<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01696461</url>
  </required_header>
  <id_info>
    <org_study_id>09-PLEX</org_study_id>
    <nct_id>NCT01696461</nct_id>
  </id_info>
  <brief_title>A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor</brief_title>
  <official_title>A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Recipients With Hematological Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Center for International Blood and Marrow Transplant Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genzyme, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Center for International Blood and Marrow Transplant Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase II, open-label, two strata, multicenter, prospective study of&#xD;
      plerixafor-mobilized HLA-identical sibling allografts in recipients with hematological&#xD;
      malignancies. This study will establish the safety and efficacy of subcutaneous plerixafor&#xD;
      for this purpose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective is to determine the proportion of donors whose cells can be&#xD;
      successfully mobilized and collected with a sufficient CD34+ cell dose using plerixafor as&#xD;
      the mobilizing agent, using an intention-to-treat analysis. Donor mobilization following&#xD;
      plerixafor will be considered successful if ≥ 2.0x10e6 CD34+ cells/kg recipient weight are&#xD;
      collected in no more than two leukapheresis collections.&#xD;
&#xD;
      All donors receiving plerixafor will be included in the analysis of the primary objective&#xD;
      based on the intention-to-treat principle.Recipients will be classified into one of the two&#xD;
      strata, myeloablative or reduced intensity, according to his/her conditioning regimen. The&#xD;
      target enrollment is 64 donor/recipient pairs, 32 pairs per stratum.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Donors Whose Cells Were Successfully Mobilized and Collected With a Sufficient CD34+ Cell Dose Using Plerixafor as the Mobilizing Agent, Using an Intention-to-treat Analysis.</measure>
    <time_frame>donation</time_frame>
    <description>Donor mobilization following plerixafor was considered successful if ≥ 2.0x106 CD34+ cells/kg recipient weight was collected in no more than two leukapheresis collections.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and Severity of Acute Toxicities</measure>
    <time_frame>baseline, Day 1, Day 2, Day 3</time_frame>
    <description>Incidence and severity of acute toxicities before and during apheresis experienced by donors receiving plerixafor. Acute toxicities are graded according to the NCI Common Terminology Criteria for Adverse Events, version 4.0. This outcome measure is descriptive. Grade of maximum toxicity across all time points is reported. Higher grades denote worse outcomes. 0 = None, 1 = Mild, 2 = Moderate, 3 = severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Effects</measure>
    <time_frame>30 minutes, 60 minutes, 120 minutes, 240 minutes, 1 month, 6 months, 12 months post donation for each subject</time_frame>
    <description>Adverse effects experienced by donors receiving plerixafor up to one year post donation. Number of participants with a maximum MTC &gt;0 reported at each individual time point. Adverse effects are graded according to the NCI Common Terminology Criteria for Adverse Events, version 4.0. This outcome measure is descriptive. Participants can experience adverse effects at more than one time point evaluated. Higher grades denote worse outcomes. 0 = None, 1 = Mild, 2 = Moderate, 3 = severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of and Kinetics of Neutrophil and Platelet Recovery After Transplantation of Hematopoietic Cells Mobilized With Plerixafor</measure>
    <time_frame>Day +1 through neutrophil recovery or Day 21 (whichever is first)</time_frame>
    <description>Incidence of and kinetics of neutrophil and platelet recovery by day 100 in recipients after transplantation of hematopoietic cells mobilized with plerixafor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor</measure>
    <time_frame>Chimerism was evaluated at serial timepoints post HCT in patients in both RIC and MAC strata. Chimerism was assessed at Day +28, +100, +180, and +365</time_frame>
    <description>T-cell (CD3+) and myeloid (CD33+) chimerism in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor</measure>
    <time_frame>Day 28</time_frame>
    <description>Incidence of primary graft failure in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Acute Graft-versus-host Disease (GVHD)</measure>
    <time_frame>Day 100</time_frame>
    <description>Incidence of acute graft-versus-host disease (GVHD) in recipients after transplantation of hematopoietic cells mobilized with plerixafor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune Reconstitution</measure>
    <time_frame>Day 28, 100, 180, 365</time_frame>
    <description>Rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with plerixafor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Cytomegalovirus (CMV) Reactivation After Transplantation With Cells Mobilized With Plerixafor.</measure>
    <time_frame>day 365</time_frame>
    <description>Percentage of recipients with prior CMV infection whose CMV was reactivated after transplantation with cell mobilized with plerixafor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-related Mortality and Disease Relapse/Progression</measure>
    <time_frame>Day 180, 365</time_frame>
    <description>Incidence of treatment-related mortality and disease relapse/progression in recipients after transplantation of hematopoietic cells mobilized with plerixafor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free and Overall Survival</measure>
    <time_frame>Day 180, 365</time_frame>
    <description>Probability of progression-free and overall survival after transplantation of hematopoietic cells mobilized with plerixafor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cellular Composition of Allografts</measure>
    <time_frame>donation</time_frame>
    <description>Cellular composition of allografts mobilized with plerixafor (stem/progenitor cells, T/B/ (Natural killer) NK-cells)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Chronic Graft-versus-host Disease (GVHD)</measure>
    <time_frame>Day 365</time_frame>
    <description>Incidence of chronic graft-versus-host disease (GVHD) in recipients after transplantation of hematopoietic cells mobilized with plerixafor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor</measure>
    <time_frame>Day 365</time_frame>
    <description>Incidence of secondary graft failure in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD34+ Cell Count of Allografts</measure>
    <time_frame>donation</time_frame>
    <description>CD34+ cell count of allografts mobilized with plerixafor</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Related Donors Donating Peripheral Blood Stem Cells (PBSC) to a Family Member</condition>
  <condition>Acute Myelogenous Leukemia</condition>
  <condition>Acute Lymphoblastic Leukemia</condition>
  <condition>Myelodysplastic Syndrome</condition>
  <condition>Chronic Myelogenous Leukemia</condition>
  <condition>Non-Hodgkin's Lymphoma</condition>
  <condition>Hodgkin's Disease</condition>
  <condition>Chronic Lymphocytic Leukemia</condition>
  <arm_group>
    <arm_group_label>Related donors receiving plerixafor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent.&#xD;
Eligible donors determined according to institutional standards&#xD;
18-65 years of age&#xD;
6/6 HLA-matched sibling&#xD;
Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor&#xD;
Serum creatinine &lt;1.5 x institution upper limit of normal (ULN) or estimated creatinine clearance (CLCR) &gt;50 mL/min&#xD;
Treatment Description:&#xD;
Receive subcutaneous plerixafor at 240 μg/kg and commence leukapheresis approximately 4 hours later.&#xD;
Leukapheresis will be performed up to two consecutive days. The target CD34+ cell dose is &gt; 4.0 x 106/kg with a minimum of &gt; 2.0 x 106/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recipients, myeloablative regimen</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients undergoing conditioning under a myeloablative regimen&#xD;
Myeloablative (one of four general regimens):&#xD;
Busulfan (&gt; 9 mg/kg po or iv total) with fludarabine Busulfan (&gt; 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (&gt; 1000 cGy) plus etoposide Total body irradiation (&gt; 500 cGy) plus cyclophosphamide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recipients, reduced intensity conditioning regimen.</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients undergoing conditioning using a reduced intensity conditioning regimen.&#xD;
Reduced Intensity (one of three general regimens):&#xD;
Busulfan (&lt; 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (&gt; 2000 mg/m2 total)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Plerixafor</intervention_name>
    <arm_group_label>Related donors receiving plerixafor</arm_group_label>
    <other_name>Mozobil</other_name>
    <other_name>AMD3000</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Donor:&#xD;
&#xD;
          -  Donor eligibility will be determined according to applicable federal, state and local&#xD;
             regulations and institutional standards&#xD;
&#xD;
          -  18-65 years of age&#xD;
&#xD;
          -  6/6 HLA-matched sibling&#xD;
&#xD;
          -  Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor&#xD;
&#xD;
          -  Serum creatinine &lt;2.0mg/dl&#xD;
&#xD;
        Recipient:&#xD;
&#xD;
          -  18 to 65 years of age&#xD;
&#xD;
          -  6/6 HLA antigen matched sibling willing to donate PBSC for transplant&#xD;
&#xD;
          -  Fulfill individual Transplant Center Criteria for transplant&#xD;
&#xD;
          -  One of the following diagnoses:&#xD;
&#xD;
               -  Acute myelogenous leukemia (AML) in 1st remission or beyond with &lt;5% marrow&#xD;
                  blasts and no circulating blasts. Marrow must be done within 30 days of the start&#xD;
                  of transplant conditioning regimen in alignment with other pre-transplant&#xD;
                  assessments.&#xD;
&#xD;
               -  Acute lymphoblastic leukemia (ALL) in 1st remission or beyond with &lt;5% marrow&#xD;
                  blasts and no circulating blasts&#xD;
&#xD;
               -  Myelodysplastic syndrome, either intermediate-1,2, or high risk by International&#xD;
                  Prognostic Scoring System or transfusion dependent&#xD;
&#xD;
               -  Chronic myelogenous leukemia (CML) failing or intolerant to tyrosine kinase&#xD;
                  inhibitor based therapy&#xD;
&#xD;
               -  Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater complete&#xD;
                  remission, partial remission, or in relapse (but with at least stable disease&#xD;
                  after most recent therapy)&#xD;
&#xD;
               -  Chronic lymphocytic leukemia (CLL), relapsing after at least one prior regimen,&#xD;
                  or in remission with 17p deletion&#xD;
&#xD;
          -  Serum creatinine must be &lt;2.0mg/dl&#xD;
&#xD;
          -  Total bilirubin and aspartate aminotransferase (AST) &lt;3x normal&#xD;
&#xD;
          -  Infectious disease marker (IDM) monitoring will be performed per institutional&#xD;
             standards&#xD;
&#xD;
          -  Karnofsky performance status of 70% or greater.&#xD;
&#xD;
          -  Patients who have undergone a prior autologous transplantation are eligible for a&#xD;
             reduced intensity transplant only&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Donor:&#xD;
&#xD;
          -  Donor unwilling or unable to give informed consent, or unable to comply with the&#xD;
             protocol including required follow-up and testing&#xD;
&#xD;
          -  Donor already enrolled on another investigational agent study&#xD;
&#xD;
          -  Pregnant or breast feeding females, or females not willing or able to use adequate&#xD;
             contraception if sexually active&#xD;
&#xD;
        Recipient:&#xD;
&#xD;
          -  Patient unwilling or unable to give informed consent, or unable to comply with the&#xD;
             protocol including required follow-up and testing&#xD;
&#xD;
          -  Patients with active, uncontrolled infection at the time of the transplant preparative&#xD;
             regimen&#xD;
&#xD;
          -  Pregnant or breast feeding females, or females not willing or able to use adequate&#xD;
             contraception if sexually active&#xD;
&#xD;
          -  Patients with a history of previous central nervous system (CNS) tumor involvement&#xD;
             showing active symptoms or signs along with documented disease on lumbar puncture and&#xD;
             MRI of the brain within 30 days of start of conditioning&#xD;
&#xD;
          -  A condition, which, in the opinion of the clinical investigator, would interfere with&#xD;
             the evaluation of primary and secondary endpoints.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steve Devine, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NMDP/BeTheMatch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <results_first_submitted>January 28, 2021</results_first_submitted>
  <results_first_submitted_qc>September 8, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">September 14, 2023</results_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Hodgkin Disease</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Plerixafor</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Eligible donor-recipient pairs were recruited at 12 US hematopoietic cell transplantation (HCT) transplant centers between July 2013 and December 2014. Recipients who met eligibility criteria provided written informed consent prior to any study procedure being performed. In order for the recipient to proceed in the study, intended donors were required to consent as well.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Related Donors Receiving Plerixafor</title>
          <description>Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent.&#xD;
Donor eligibility was determined according to institutional standards Donors met the following criteria:&#xD;
18-65 years of age&#xD;
6/6 HLA-matched sibling&#xD;
Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor&#xD;
Serum creatinine &lt;1.5 x institution ULN or estimated creatinine clearance (CLCR) &gt;50 mL/min&#xD;
Treatment Description:&#xD;
Receive subcutaneous plerixafor at 240 μg/kg and commence leukapheresis approximately 4 hours later.&#xD;
Leukapheresis will be performed up to two consecutive days. The target CD34+ cell dose is &gt; 4.0 x 106/kg with a minimum of &gt; 2.0 x 106/kg.</description>
        </group>
        <group group_id="P2">
          <title>Recipients, Reduced Intensity</title>
          <description>Reduced Intensity (one of three general regimens):&#xD;
Busulfan (&lt; 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (&gt; 2000 mg/m2 total).</description>
        </group>
        <group group_id="P3">
          <title>Recipients Myeloablative Regimen</title>
          <description>Myeloablative (one of four general regimens):&#xD;
Busulfan (&gt; 9 mg/kg po or iv total) with fludarabine Busulfan (&gt; 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (&gt; 1000 cGy) plus etoposide Total body irradiation (&gt; 500 cGy) plus cyclophosphamide</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="64">First donor-recipient pair was enrolled in July, 2013.</participants>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="64">Last donor-recipient pair was enrolled in December, 2014</participants>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Related Donors Receiving Plerixafor</title>
          <description>Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent.&#xD;
Eligible donors determined according to institutional standards&#xD;
18-65 years of age&#xD;
6/6 HLA-matched sibling&#xD;
Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor&#xD;
Serum creatinine &lt;1.5 x institution ULN or estimated creatinine clearance (CLCR) &gt;50 mL/min&#xD;
Treatment Description:&#xD;
Receive subcutaneous plerixafor at 240 μg/kg and commence leukapheresis approximately 4 hours later.&#xD;
Leukapheresis will be performed up to two consecutive days. The target CD34+ cell dose is &gt; 4.0 x 106/kg with a minimum of &gt; 2.0 x 10E6/kg.</description>
        </group>
        <group group_id="B2">
          <title>Recipients, Myeloablative Conditioning Regimen</title>
          <description>Myeloablative (one of four general regimens):&#xD;
Busulfan (&gt; 9 mg/kg po or iv total) with fludarabine Busulfan (&gt; 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (&gt; 1000 cGy) plus etoposide Total body irradiation (&gt; 500 cGy) plus cyclophosphamide</description>
        </group>
        <group group_id="B3">
          <title>Recipients, Reduced Intensity Conditioning Regimen</title>
          <description>Reduced Intensity (one of three general regimens):&#xD;
Busulfan (&lt; 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (&gt; 2000 mg/m2 total)</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="64"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="33"/>
            <count group_id="B4" value="127"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Donor age at collection, years</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="121"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Information collected by subject response to questions on case report forms</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Donors Whose Cells Were Successfully Mobilized and Collected With a Sufficient CD34+ Cell Dose Using Plerixafor as the Mobilizing Agent, Using an Intention-to-treat Analysis.</title>
        <description>Donor mobilization following plerixafor was considered successful if ≥ 2.0x106 CD34+ cells/kg recipient weight was collected in no more than two leukapheresis collections.</description>
        <time_frame>donation</time_frame>
        <population>Recipients were not mobilized with plerixafor.</population>
        <group_list>
          <group group_id="O1">
            <title>Related Donors Receiving Plerixafor</title>
            <description>Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent.&#xD;
Eligible donors determined according to institutional standards&#xD;
18-65 years of age&#xD;
6/6 HLA-matched sibling&#xD;
Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor&#xD;
Serum creatinine &lt;1.5 x institution ULN or estimated creatinine clearance (CLCR) &gt;50 mL/min&#xD;
Treatment Description:&#xD;
Receive subcutaneous plerixafor at 240 μg/kg and commence leukapheresis approximately 4 hours later.&#xD;
Leukapheresis will be performed up to two consecutive days. The target CD34+ cell dose is &gt; 4.0 x 106/kg with a minimum of &gt; 2.0 x 10E6/kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Donors Whose Cells Were Successfully Mobilized and Collected With a Sufficient CD34+ Cell Dose Using Plerixafor as the Mobilizing Agent, Using an Intention-to-treat Analysis.</title>
          <description>Donor mobilization following plerixafor was considered successful if ≥ 2.0x106 CD34+ cells/kg recipient weight was collected in no more than two leukapheresis collections.</description>
          <population>Recipients were not mobilized with plerixafor.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Percentage of donors mobilized with plerixafor. No comparison group was analyzed.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence and Severity of Acute Toxicities</title>
        <description>Incidence and severity of acute toxicities before and during apheresis experienced by donors receiving plerixafor. Acute toxicities are graded according to the NCI Common Terminology Criteria for Adverse Events, version 4.0. This outcome measure is descriptive. Grade of maximum toxicity across all time points is reported. Higher grades denote worse outcomes. 0 = None, 1 = Mild, 2 = Moderate, 3 = severe.</description>
        <time_frame>baseline, Day 1, Day 2, Day 3</time_frame>
        <population>Recipients were not analyzed for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Related Donors Receiving Plerixafor</title>
            <description>Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent.&#xD;
Eligible donors determined according to institutional standards&#xD;
18-65 years of age&#xD;
6/6 HLA-matched sibling&#xD;
Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor&#xD;
Serum creatinine &lt;1.5 x institution ULN or estimated creatinine clearance (CLCR) &gt;50 mL/min&#xD;
Treatment Description:&#xD;
Receive subcutaneous plerixafor at 240 μg/kg and commence leukapheresis approximately 4 hours later.&#xD;
Leukapheresis will be performed up to two consecutive days. The target CD34+ cell dose is &gt; 4.0 x 106/kg with a minimum of &gt; 2.0 x 106/kg.&#xD;
Plerixafor</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence and Severity of Acute Toxicities</title>
          <description>Incidence and severity of acute toxicities before and during apheresis experienced by donors receiving plerixafor. Acute toxicities are graded according to the NCI Common Terminology Criteria for Adverse Events, version 4.0. This outcome measure is descriptive. Grade of maximum toxicity across all time points is reported. Higher grades denote worse outcomes. 0 = None, 1 = Mild, 2 = Moderate, 3 = severe.</description>
          <population>Recipients were not analyzed for this outcome measure</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Max Modified toxicity criteria (MTC) = 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Max Modified toxicity criteria (MTC) = 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Max Modified toxicity criteria (MTC) = 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Max Modified toxicity criteria (MTC) = 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>This is a descriptive analysis. Percentage of donor experiencing toxicities was assessed at 30, 60, 120, and 240 minutes after administration of plerixafor on each day of collection and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.3. Grade of maximum toxicity across all time points is reported.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Effects</title>
        <description>Adverse effects experienced by donors receiving plerixafor up to one year post donation. Number of participants with a maximum MTC &gt;0 reported at each individual time point. Adverse effects are graded according to the NCI Common Terminology Criteria for Adverse Events, version 4.0. This outcome measure is descriptive. Participants can experience adverse effects at more than one time point evaluated. Higher grades denote worse outcomes. 0 = None, 1 = Mild, 2 = Moderate, 3 = severe.</description>
        <time_frame>30 minutes, 60 minutes, 120 minutes, 240 minutes, 1 month, 6 months, 12 months post donation for each subject</time_frame>
        <population>Recipients did not receive plerixafor and were not examined for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Related Donors Receiving Plerixafor</title>
            <description>Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent.&#xD;
Donor eligibility was determined according to institutional standards Donors met the following criteria:&#xD;
18-65 years of age&#xD;
6/6 HLA-matched sibling&#xD;
Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor&#xD;
Serum creatinine &lt;1.5 x institution ULN or estimated creatinine clearance (CLCR) &gt;50 mL/min&#xD;
Treatment Description:&#xD;
Receive subcutaneous plerixafor at 240 μg/kg and commence leukapheresis approximately 4 hours later.&#xD;
Leukapheresis will be performed up to two consecutive days. The target CD34+ cell dose is &gt; 4.0 x 106/kg with a minimum of &gt; 2.0 x 106/kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Effects</title>
          <description>Adverse effects experienced by donors receiving plerixafor up to one year post donation. Number of participants with a maximum MTC &gt;0 reported at each individual time point. Adverse effects are graded according to the NCI Common Terminology Criteria for Adverse Events, version 4.0. This outcome measure is descriptive. Participants can experience adverse effects at more than one time point evaluated. Higher grades denote worse outcomes. 0 = None, 1 = Mild, 2 = Moderate, 3 = severe.</description>
          <population>Recipients did not receive plerixafor and were not examined for this outcome.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 minutes after administration of plerixafor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes after administration of plerixafor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 minutes after administration of plerixafor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>240 minutes after administration of plerixafor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>One month after administration of plerixafor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Six months after administration of plerixafor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Twelve months after administration of plerixafor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>This is a descriptive analysis. The number of donors experiencing toxicities was assessed at 30, 60, 120, and 240 minutes after administration of plerixafor on each day of collection and one, six, and 12 months post-donation. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.3.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of and Kinetics of Neutrophil and Platelet Recovery After Transplantation of Hematopoietic Cells Mobilized With Plerixafor</title>
        <description>Incidence of and kinetics of neutrophil and platelet recovery by day 100 in recipients after transplantation of hematopoietic cells mobilized with plerixafor.</description>
        <time_frame>Day +1 through neutrophil recovery or Day 21 (whichever is first)</time_frame>
        <population>Patients were classified to one of the two conditioning regimens - myeloablative (MAC) or reduced intensity conditioning (RIC). A total of 30 MAC and 33 RIC patients were analyzed for this outcome. Neutrophil engraftment was defined as time from day 0 of HCT to the first of 3 consecutive measurements of absolute neutrophil count ≥0.5 × 109/L. Platelet engraftment was defined as the number of days from day 0 of HCT to the first of 3 consecutive values of platelet count ≥20 × 109/L.</population>
        <group_list>
          <group group_id="O1">
            <title>Recipients, Myeloablative Conditioning Regimen</title>
            <description>Myeloablative (one of four general regimens):&#xD;
Busulfan (&gt; 9 mg/kg po or iv total) with fludarabine Busulfan (&gt; 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (&gt; 1000 cGy) plus etoposide Total body irradiation (&gt; 500 cGy) plus cyclophosphamide</description>
          </group>
          <group group_id="O2">
            <title>Recipients, Reduced Intensity Conditioning Regimen</title>
            <description>Reduced Intensity (one of three general regimens):&#xD;
Busulfan (&lt; 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (&gt; 2000 mg/m2 total)</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of and Kinetics of Neutrophil and Platelet Recovery After Transplantation of Hematopoietic Cells Mobilized With Plerixafor</title>
          <description>Incidence of and kinetics of neutrophil and platelet recovery by day 100 in recipients after transplantation of hematopoietic cells mobilized with plerixafor.</description>
          <population>Patients were classified to one of the two conditioning regimens - myeloablative (MAC) or reduced intensity conditioning (RIC). A total of 30 MAC and 33 RIC patients were analyzed for this outcome. Neutrophil engraftment was defined as time from day 0 of HCT to the first of 3 consecutive measurements of absolute neutrophil count ≥0.5 × 109/L. Platelet engraftment was defined as the number of days from day 0 of HCT to the first of 3 consecutive values of platelet count ≥20 × 109/L.</population>
          <units>Percentage probability of engraftment</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Neutrophil engraftment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="100" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="100" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet engraftment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="100" upper_limit="100"/>
                    <measurement group_id="O2" value="97" lower_limit="97" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>At 100 days after HCT, all patients in both the MAC and the RIC cohorts had achieved neutrophil engraftment. All patients in the MAC arm and 97% of patients in the RIC arm had achieved platelet engraftment. The median time to neutrophil engraftment was 13 and 15 days for MAC and RIC, respectively. The median time to platelet engraftment was 19 and 18 days for MAC and RIC, respectively.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor</title>
        <description>T-cell (CD3+) and myeloid (CD33+) chimerism in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.</description>
        <time_frame>Chimerism was evaluated at serial timepoints post HCT in patients in both RIC and MAC strata. Chimerism was assessed at Day +28, +100, +180, and +365</time_frame>
        <population>Chimerism is not evaluated in donor arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Recipients, Myeloablative Conditioning Regimen</title>
            <description>Myeloablative (one of four general regimens):&#xD;
Busulfan (&gt; 9 mg/kg po or iv total) with fludarabine Busulfan (&gt; 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (&gt; 1000 cGy) plus etoposide Total body irradiation (&gt; 500 cGy) plus cyclophosphamide</description>
          </group>
          <group group_id="O2">
            <title>Recipients, Reduced Intensity Conditioning Regimen</title>
            <description>Reduced Intensity (one of three general regimens):&#xD;
Busulfan (&lt; 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (&gt; 2000 mg/m2 total)</description>
          </group>
        </group_list>
        <measure>
          <title>T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor</title>
          <description>T-cell (CD3+) and myeloid (CD33+) chimerism in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.</description>
          <population>Chimerism is not evaluated in donor arm.</population>
          <units>percentage of donor cell chimerism</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Myeloid chimerism (Day 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="91" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T-cell chimerism (Day 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92" lower_limit="59" upper_limit="100"/>
                    <measurement group_id="O2" value="80" lower_limit="50" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myeloid chimerism (Day 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="91" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="17" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T-cell chimerism (Day 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97" lower_limit="76" upper_limit="100"/>
                    <measurement group_id="O2" value="84" lower_limit="64" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myeloid chimerism (Day 180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="89" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="5" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T-cell chimerism (Day 180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="91" upper_limit="100"/>
                    <measurement group_id="O2" value="95" lower_limit="5" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myeloid chimerism (Day 365)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="100" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T-cell chimerism (Day 365)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="100" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Full donor myeloid chimerism was achieved relatively quickly in both RIC and MAC groups (median 100% at day +28 in both RIC and MAC), but conversion to full donor T-cell chimerism appeared to be slower in the RIC patients.&#xD;
T-cell chimerism for MAC patients: median donor cell % (range):&#xD;
Day +28: 92(59-100)%, Day +100: 97(76-100)%, Day +180: 100(91-100)%, Day +365: 100(100-100)%&#xD;
T-cell chimerism for RIC patients: median donor cell % (range):&#xD;
Day +28: 80(50-100)%, Day +100: 84(64-100)%, Day +180: 95(74-100)%, Day +365: 100(87-100)%</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Primary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor</title>
        <description>Incidence of primary graft failure in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.</description>
        <time_frame>Day 28</time_frame>
        <population>Donor population did not receive a transplant</population>
        <group_list>
          <group group_id="O1">
            <title>Recipients, Myeloablative Conditioning Regimen</title>
            <description>Myeloablative (one of four general regimens):&#xD;
Busulfan (&gt; 9 mg/kg po or iv total) with fludarabine Busulfan (&gt; 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (&gt; 1000 cGy) plus etoposide Total body irradiation (&gt; 500 cGy) plus cyclophosphamide</description>
          </group>
          <group group_id="O2">
            <title>Recipients, Reduced Intensity Conditioning Regimen</title>
            <description>Busulfan (&lt; 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (&gt; 2000 mg/m2 total)</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor</title>
          <description>Incidence of primary graft failure in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.</description>
          <population>Donor population did not receive a transplant</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>This is a descriptive outcome.There were no cases of primary graft failure.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Acute Graft-versus-host Disease (GVHD)</title>
        <description>Incidence of acute graft-versus-host disease (GVHD) in recipients after transplantation of hematopoietic cells mobilized with plerixafor</description>
        <time_frame>Day 100</time_frame>
        <population>Donor arm did not receive a transplant. This group was not analyzed for graft-vs-host disease</population>
        <group_list>
          <group group_id="O1">
            <title>Recipients, Myeloablative Conditioning Regimen</title>
            <description>Myeloablative (one of four general regimens):&#xD;
Busulfan (&gt; 9 mg/kg po or iv total) with fludarabine Busulfan (&gt; 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (&gt; 1000 cGy) plus etoposide Total body irradiation (&gt; 500 cGy) plus cyclophosphamide</description>
          </group>
          <group group_id="O2">
            <title>Recipients, Reduced Intensity Conditioning Regimen</title>
            <description>Busulfan (&lt; 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (&gt; 2000 mg/m2 total)</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Acute Graft-versus-host Disease (GVHD)</title>
          <description>Incidence of acute graft-versus-host disease (GVHD) in recipients after transplantation of hematopoietic cells mobilized with plerixafor</description>
          <population>Donor arm did not receive a transplant. This group was not analyzed for graft-vs-host disease</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 2-4 aGVHD by day 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53" lower_limit="35" upper_limit="71"/>
                    <measurement group_id="O2" value="18" lower_limit="7" upper_limit="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3-4 aGVHD by day 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" lower_limit="6" upper_limit="32"/>
                    <measurement group_id="O2" value="3" lower_limit="0" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The cumulative incidence of acute graft-vs-host disease was examined in the RIC and MAC groups but was not directly compared with a statistical test.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>The incidence of acute GVHD was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. Death was treated as a competing risk.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immune Reconstitution</title>
        <description>Rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with plerixafor.</description>
        <time_frame>Day 28, 100, 180, 365</time_frame>
        <population>Donor population did not receive a transplant. Immune reconstitution was not measured in the donor population.</population>
        <group_list>
          <group group_id="O1">
            <title>Recipients, Myeloablative Conditioning Regimen</title>
            <description>Myeloablative (one of four general regimens):&#xD;
Busulfan (&gt; 9 mg/kg po or iv total) with fludarabine Busulfan (&gt; 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (&gt; 1000 cGy) plus etoposide Total body irradiation (&gt; 500 cGy) plus cyclophosphamide</description>
          </group>
          <group group_id="O2">
            <title>Recipients, Reduced Intensity Conditioning Regimen</title>
            <description>Reduced Intensity (one of three general regimens):&#xD;
Busulfan (&lt; 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (&gt; 2000 mg/m2 total)</description>
          </group>
        </group_list>
        <measure>
          <title>Immune Reconstitution</title>
          <description>Rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with plerixafor.</description>
          <population>Donor population did not receive a transplant. Immune reconstitution was not measured in the donor population.</population>
          <units>Cells*10^3/mm^3</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD3+ (Day 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="589" lower_limit="48" upper_limit="2250"/>
                    <measurement group_id="O2" value="478" lower_limit="49" upper_limit="1485"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ (Day 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="363" lower_limit="23" upper_limit="1364"/>
                    <measurement group_id="O2" value="214" lower_limit="28" upper_limit="676"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ (Day 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="197" lower_limit="19" upper_limit="837"/>
                    <measurement group_id="O2" value="127" lower_limit="8" upper_limit="918"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD3+ (Day100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="647" lower_limit="61" upper_limit="1671"/>
                    <measurement group_id="O2" value="529" lower_limit="40" upper_limit="1387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ (Day 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="339" lower_limit="20" upper_limit="714"/>
                    <measurement group_id="O2" value="265" lower_limit="25" upper_limit="650"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ (Day 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="242" lower_limit="12" upper_limit="1069"/>
                    <measurement group_id="O2" value="162" lower_limit="13" upper_limit="998"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD3+ (Day 180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="638" lower_limit="58" upper_limit="1964"/>
                    <measurement group_id="O2" value="699" lower_limit="69" upper_limit="1517"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ (Day 180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="352" lower_limit="16" upper_limit="851"/>
                    <measurement group_id="O2" value="257" lower_limit="18" upper_limit="769"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ (Day 180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="272" lower_limit="26" upper_limit="1080"/>
                    <measurement group_id="O2" value="219" lower_limit="37" upper_limit="862"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD3+ (Day 365)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="794" lower_limit="62" upper_limit="1780"/>
                    <measurement group_id="O2" value="1094" lower_limit="207" upper_limit="2448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ (Day 365)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="495" lower_limit="27" upper_limit="932"/>
                    <measurement group_id="O2" value="457" lower_limit="92" upper_limit="775"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ (Day 365)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="264" lower_limit="25" upper_limit="963"/>
                    <measurement group_id="O2" value="460" lower_limit="106" upper_limit="1608"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Immune reconstitution was measured by CD3+CD4+ and CD3+CD8+ T cells in the peripheral blood of patients at days 28, 100, 180, and 365 after HCT. Notably, median CD3+CD4+ cell counts were &gt;200/µL at all times analyzed, including day 28 in both MAC and RIC groups.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Cytomegalovirus (CMV) Reactivation After Transplantation With Cells Mobilized With Plerixafor.</title>
        <description>Percentage of recipients with prior CMV infection whose CMV was reactivated after transplantation with cell mobilized with plerixafor</description>
        <time_frame>day 365</time_frame>
        <population>Donor population did not receive a transplant. Only those with prior infection were eligible to be analyzed for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Recipients, Myeloablative Conditioning Regimen</title>
            <description>Myeloablative (one of four general regimens):&#xD;
Busulfan (&gt; 9 mg/kg po or iv total) with fludarabine Busulfan (&gt; 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (&gt; 1000 cGy) plus etoposide Total body irradiation (&gt; 500 cGy) plus cyclophosphamide</description>
          </group>
          <group group_id="O2">
            <title>Recipients, Reduced Intensity Conditioning Regimen</title>
            <description>Reduced Intensity (one of three general regimens):&#xD;
Busulfan (&lt; 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (&gt; 2000 mg/m2 total)</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Cytomegalovirus (CMV) Reactivation After Transplantation With Cells Mobilized With Plerixafor.</title>
          <description>Percentage of recipients with prior CMV infection whose CMV was reactivated after transplantation with cell mobilized with plerixafor</description>
          <population>Donor population did not receive a transplant. Only those with prior infection were eligible to be analyzed for this outcome measure</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Groups were not directly compared using a statistical test.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Percentage of recipients at-risk for CMV reactivation who experienced a reactivation.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment-related Mortality and Disease Relapse/Progression</title>
        <description>Incidence of treatment-related mortality and disease relapse/progression in recipients after transplantation of hematopoietic cells mobilized with plerixafor</description>
        <time_frame>Day 180, 365</time_frame>
        <population>Related donors did not receive a transplant and were not examined for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Recipients, Myeloablative Conditioning Regimen</title>
            <description>Myeloablative (one of four general regimens):&#xD;
Busulfan (&gt; 9 mg/kg po or iv total) with fludarabine Busulfan (&gt; 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (&gt; 1000 cGy) plus etoposide Total body irradiation (&gt; 500 cGy) plus cyclophosphamide</description>
          </group>
          <group group_id="O2">
            <title>Recipients, Reduced Intensity Conditioning Regimen</title>
            <description>Reduced Intensity (one of three general regimens):&#xD;
Busulfan (&lt; 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (&gt; 2000 mg/m2 total)</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment-related Mortality and Disease Relapse/Progression</title>
          <description>Incidence of treatment-related mortality and disease relapse/progression in recipients after transplantation of hematopoietic cells mobilized with plerixafor</description>
          <population>Related donors did not receive a transplant and were not examined for this outcome.</population>
          <units>Percentage probability of outcome</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment-related mortality (180 days)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="1" upper_limit="18"/>
                    <measurement group_id="O2" value="3" lower_limit="0" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related mortality (365 days)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" lower_limit="6" upper_limit="32"/>
                    <measurement group_id="O2" value="6" lower_limit="1" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relapse/progression of disease (180 days)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="15" upper_limit="47"/>
                    <measurement group_id="O2" value="28" lower_limit="14" upper_limit="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relapse/progression of disease (365 days)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="15" upper_limit="48"/>
                    <measurement group_id="O2" value="30" lower_limit="16" upper_limit="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The probability of treatment-related mortality and disease relapse/progression were examined in the RIC and MAC cohorts but were not directly compared between the two groups using a statistical test.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>The incidence of treatment-related mortality and relapse was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. When computing the cumulative incidence probability of treatment-related mortality and relapse, relapse and treatment-related mortality, respectively, were considered as a competing risk.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free and Overall Survival</title>
        <description>Probability of progression-free and overall survival after transplantation of hematopoietic cells mobilized with plerixafor</description>
        <time_frame>Day 180, 365</time_frame>
        <population>Donor population did not receive a transplantation and therefore was not analyzed for this outcome</population>
        <group_list>
          <group group_id="O1">
            <title>Recipients, Myeloablative Conditioning Regimen</title>
            <description>Myeloablative (one of four general regimens):&#xD;
Busulfan (&gt; 9 mg/kg po or iv total) with fludarabine Busulfan (&gt; 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (&gt; 1000 cGy) plus etoposide Total body irradiation (&gt; 500 cGy) plus cyclophosphamide</description>
          </group>
          <group group_id="O2">
            <title>Recipients, Reduced Intensity Conditioning Regimen</title>
            <description>Reduced Intensity (one of three general regimens):&#xD;
Busulfan (&lt; 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (&gt; 2000 mg/m2 total)</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free and Overall Survival</title>
          <description>Probability of progression-free and overall survival after transplantation of hematopoietic cells mobilized with plerixafor</description>
          <population>Donor population did not receive a transplantation and therefore was not analyzed for this outcome</population>
          <units>Percentage probability of outcome</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Progression free survival (180 days)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63" lower_limit="46" upper_limit="79"/>
                    <measurement group_id="O2" value="69" lower_limit="52" upper_limit="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progression free survival (365 days)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53" lower_limit="36" upper_limit="71"/>
                    <measurement group_id="O2" value="64" lower_limit="47" upper_limit="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall survival (180 days)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87" lower_limit="72" upper_limit="96"/>
                    <measurement group_id="O2" value="79" lower_limit="63" upper_limit="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall survival (365 days)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63" lower_limit="46" upper_limit="79"/>
                    <measurement group_id="O2" value="70" lower_limit="53" upper_limit="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The probability of progression free survival and overall survival were examined in the RIC and MAC cohorts but were not directly compared between the two groups using a statistical test.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Kaplan-Meier curves were used to estimate the probability of progression-free survival and overall survival. Progression-free survival at 1 year was 53% (95% CI, 36% to 71%) after MAC and 64% (95% CI, 47% to 79%) after RIC. Overall survival at 1 year was 63% (95% CI, 46% to 79%) after MAC and 70% (95% CI, 53% to 84%) after RIC.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cellular Composition of Allografts</title>
        <description>Cellular composition of allografts mobilized with plerixafor (stem/progenitor cells, T/B/ (Natural killer) NK-cells)</description>
        <time_frame>donation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Related Donors Receiving Plerixafor</title>
            <description>Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent.&#xD;
Donor eligibility was determined according to institutional standards Donors met the following criteria:&#xD;
18-65 years of age&#xD;
6/6 HLA-matched sibling&#xD;
Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor&#xD;
Serum creatinine &lt;1.5 x institution ULN or estimated creatinine clearance (CLCR) &gt;50 mL/min&#xD;
Treatment Description:&#xD;
Receive subcutaneous plerixafor at 240 μg/kg and commence leukapheresis approximately 4 hours later.&#xD;
Leukapheresis will be performed up to two consecutive days. The target CD34+ cell dose is &gt; 4.0 x 106/kg with a minimum of &gt; 2.0 x 106/kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Cellular Composition of Allografts</title>
          <description>Cellular composition of allografts mobilized with plerixafor (stem/progenitor cells, T/B/ (Natural killer) NK-cells)</description>
          <units>cells*10^8/kg</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.96" lower_limit="2.72" upper_limit="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD3+CD4+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.57" lower_limit="2.0" upper_limit="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD3+CD8+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.18" lower_limit="0.48" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD19+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.47" lower_limit="0.23" upper_limit="7.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD56+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" lower_limit="0.0" upper_limit="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>This outcome measure is descriptive.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>This outcome measure is descriptive. The median cell dose and range are reported.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Chronic Graft-versus-host Disease (GVHD)</title>
        <description>Incidence of chronic graft-versus-host disease (GVHD) in recipients after transplantation of hematopoietic cells mobilized with plerixafor</description>
        <time_frame>Day 365</time_frame>
        <population>Donor arm did not receive a transplant. This group was not analyzed for graft-versus-host disease.</population>
        <group_list>
          <group group_id="O1">
            <title>Recipients, Myeloablative Conditioning Regimen</title>
            <description>Myeloablative (one of four general regimens):&#xD;
Busulfan (&gt; 9 mg/kg po or iv total) with fludarabine Busulfan (&gt; 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (&gt; 1000 cGy) plus etoposide Total body irradiation (&gt; 500 cGy) plus cyclophosphamide</description>
          </group>
          <group group_id="O2">
            <title>Recipients, Reduced Intensity Conditioning Regimen</title>
            <description>Busulfan (&lt; 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (&gt; 2000 mg/m2 total)</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Chronic Graft-versus-host Disease (GVHD)</title>
          <description>Incidence of chronic graft-versus-host disease (GVHD) in recipients after transplantation of hematopoietic cells mobilized with plerixafor</description>
          <population>Donor arm did not receive a transplant. This group was not analyzed for graft-versus-host disease.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52" lower_limit="33" upper_limit="70"/>
                    <measurement group_id="O2" value="39" lower_limit="23" upper_limit="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The cumulative incidence of chronic graft-vs-host disease was examined in the RIC and MAC groups but was not directly compared with a statistical test.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>The incidence of chronic GVHD was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. Death was treated as a competing event.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor</title>
        <description>Incidence of secondary graft failure in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.</description>
        <time_frame>Day 365</time_frame>
        <population>Donor population did not receive a transplant.</population>
        <group_list>
          <group group_id="O1">
            <title>Recipients, Myeloablative Conditioning Regimen</title>
            <description>Myeloablative (one of four general regimens):&#xD;
Busulfan (&gt; 9 mg/kg po or iv total) with fludarabine Busulfan (&gt; 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (&gt; 1000 cGy) plus etoposide Total body irradiation (&gt; 500 cGy) plus cyclophosphamide</description>
          </group>
          <group group_id="O2">
            <title>Recipients, Reduced Intensity Conditioning Regimen</title>
            <description>Busulfan (&lt; 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (&gt; 2000 mg/m2 total)</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor</title>
          <description>Incidence of secondary graft failure in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.</description>
          <population>Donor population did not receive a transplant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>This is a descriptive analysis. There were no cases of secondary graft failure.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CD34+ Cell Count of Allografts</title>
        <description>CD34+ cell count of allografts mobilized with plerixafor</description>
        <time_frame>donation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Related Donors Receiving Plerixafor</title>
            <description>Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent.&#xD;
Eligible donors determined according to institutional standards&#xD;
18-65 years of age&#xD;
6/6 HLA-matched sibling&#xD;
Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor&#xD;
Serum creatinine &lt;1.5 x institution ULN or estimated creatinine clearance (CLCR) &gt;50 mL/min&#xD;
Treatment Description:&#xD;
Receive subcutaneous plerixafor at 240 μg/kg and commence leukapheresis approximately 4 hours later.&#xD;
Leukapheresis will be performed up to two consecutive days. The target CD34+ cell dose is &gt; 4.0 x 106/kg with a minimum of &gt; 2.0 x 10E6/kg.</description>
          </group>
        </group_list>
        <measure>
          <title>CD34+ Cell Count of Allografts</title>
          <description>CD34+ cell count of allografts mobilized with plerixafor</description>
          <units>cells*10^6/kg</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.68" lower_limit="0.9" upper_limit="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>This outcome measure is descriptive. The median cell dose and range are reported.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Recipients were not followed for adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Related Donors Receiving Plerixafor</title>
          <description>Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent.&#xD;
Donor eligibility was determined according to institutional standards Donors met the following criteria:&#xD;
18-65 years of age&#xD;
6/6 HLA-matched sibling&#xD;
Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor&#xD;
Serum creatinine &lt;1.5 x institution ULN or estimated creatinine clearance (CLCR) &gt;50 mL/min&#xD;
Treatment Description:&#xD;
Receive subcutaneous plerixafor at 240 μg/kg and commence leukapheresis approximately 4 hours later.&#xD;
Leukapheresis will be performed up to two consecutive days. The target CD34+ cell dose is &gt; 4.0 x 106/kg with a minimum of &gt; 2.0 x 106/kg.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vasovagal reaction</sub_title>
                <description>One donor experienced a grade 3 vasovagal event at commencement of leukapheresis, which was unrelated to plerixafor.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Periorbital edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Arthalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Although this was a prospective multicenter trial, conclusions are limited by the single arm design and small sample size.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Steven Devine</name_or_title>
      <organization>National Marrow Donor Program/BeTheMatch</organization>
      <phone>7634068239</phone>
      <email>sdevine2@nmdp.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01696461
org study id: 09-PLEX
nct id: NCT01696461
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This is a Phase II, open-label, two strata, multicenter, prospective study of
      plerixafor-mobilized HLA-identical sibling allografts in recipients with hematological
      malignancies. This study will establish the safety and efficacy of subcutaneous plerixafor
      for this purpose.
The primary objective is to determine the proportion of donors whose cells can be
      successfully mobilized and collected with a sufficient CD34+ cell dose using plerixafor as
      the mobilizing agent, using an intention-to-treat analysis. Donor mobilization following
      plerixafor will be considered successful if ≥ 2.0x10e6 CD34+ cells/kg recipient weight are
      collected in no more than two leukapheresis collections.

      All donors receiving plerixafor will be included in the analysis of the primary objective
      based on the intention-to-treat principle.Recipients will be classified into one of the two
      strata, myeloablative or reduced intensity, according to his/her conditioning regimen. The
      target enrollment is 64 donor/recipient pairs, 32 pairs per stratum.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Donors Whose Cells Were Successfully Mobilized and Collected With a Sufficient CD34+ Cell Dose Using Plerixafor as the Mobilizing Agent, Using an Intention-to-treat Analysis.
time frame: donation
description: Donor mobilization following plerixafor was considered successful if ≥ 2.0x106 CD34+ cells/kg recipient weight was collected in no more than two leukapheresis collections.
measure: Incidence and Severity of Acute Toxicities
time frame: baseline, Day 1, Day 2, Day 3
description: Incidence and severity of acute toxicities before and during apheresis experienced by donors receiving plerixafor. Acute toxicities are graded according to the NCI Common Terminology Criteria for Adverse Events, version 4.0. This outcome measure is descriptive. Grade of maximum toxicity across all time points is reported. Higher grades denote worse outcomes. 0 = None, 1 = Mild, 2 = Moderate, 3 = severe.
measure: Adverse Effects
time frame: 30 minutes, 60 minutes, 120 minutes, 240 minutes, 1 month, 6 months, 12 months post donation for each subject
description: Adverse effects experienced by donors receiving plerixafor up to one year post donation. Number of participants with a maximum MTC >0 reported at each individual time point. Adverse effects are graded according to the NCI Common Terminology Criteria for Adverse Events, version 4.0. This outcome measure is descriptive. Participants can experience adverse effects at more than one time point evaluated. Higher grades denote worse outcomes. 0 = None, 1 = Mild, 2 = Moderate, 3 = severe.
measure: Incidence of and Kinetics of Neutrophil and Platelet Recovery After Transplantation of Hematopoietic Cells Mobilized With Plerixafor
time frame: Day +1 through neutrophil recovery or Day 21 (whichever is first)
description: Incidence of and kinetics of neutrophil and platelet recovery by day 100 in recipients after transplantation of hematopoietic cells mobilized with plerixafor.
measure: T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor
time frame: Chimerism was evaluated at serial timepoints post HCT in patients in both RIC and MAC strata. Chimerism was assessed at Day +28, +100, +180, and +365
description: T-cell (CD3+) and myeloid (CD33+) chimerism in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.
measure: Primary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor
time frame: Day 28
description: Incidence of primary graft failure in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.
measure: Incidence of Acute Graft-versus-host Disease (GVHD)
time frame: Day 100
description: Incidence of acute graft-versus-host disease (GVHD) in recipients after transplantation of hematopoietic cells mobilized with plerixafor
measure: Immune Reconstitution
time frame: Day 28, 100, 180, 365
description: Rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with plerixafor.
measure: Incidence of Cytomegalovirus (CMV) Reactivation After Transplantation With Cells Mobilized With Plerixafor.
time frame: day 365
description: Percentage of recipients with prior CMV infection whose CMV was reactivated after transplantation with cell mobilized with plerixafor
measure: Treatment-related Mortality and Disease Relapse/Progression
time frame: Day 180, 365
description: Incidence of treatment-related mortality and disease relapse/progression in recipients after transplantation of hematopoietic cells mobilized with plerixafor
measure: Progression-free and Overall Survival
time frame: Day 180, 365
description: Probability of progression-free and overall survival after transplantation of hematopoietic cells mobilized with plerixafor
measure: Cellular Composition of Allografts
time frame: donation
description: Cellular composition of allografts mobilized with plerixafor (stem/progenitor cells, T/B/ (Natural killer) NK-cells)
measure: Incidence of Chronic Graft-versus-host Disease (GVHD)
time frame: Day 365
description: Incidence of chronic graft-versus-host disease (GVHD) in recipients after transplantation of hematopoietic cells mobilized with plerixafor
measure: Secondary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor
time frame: Day 365
description: Incidence of secondary graft failure in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.
measure: CD34+ Cell Count of Allografts
time frame: donation
description: CD34+ cell count of allografts mobilized with plerixafor
arm group label: Related donors receiving plerixafor
arm group type: Experimental
description: Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent.
Eligible donors determined according to institutional standards
18-65 years of age
6/6 HLA-matched sibling
Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor
Serum creatinine <1.5 x institution upper limit of normal (ULN) or estimated creatinine clearance (CLCR) >50 mL/min
Treatment Description:
Receive subcutaneous plerixafor at 240 μg/kg and commence leukapheresis approximately 4 hours later.
Leukapheresis will be performed up to two consecutive days. The target CD34+ cell dose is > 4.0 x 106/kg with a minimum of > 2.0 x 106/kg.
arm group label: Recipients, myeloablative regimen
arm group type: No Intervention
description: Patients undergoing conditioning under a myeloablative regimen
Myeloablative (one of four general regimens):
Busulfan (> 9 mg/kg po or iv total) with fludarabine Busulfan (> 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (> 1000 cGy) plus etoposide Total body irradiation (> 500 cGy) plus cyclophosphamide
arm group label: Recipients, reduced intensity conditioning regimen.
arm group type: No Intervention
description: Patients undergoing conditioning using a reduced intensity conditioning regimen.
Reduced Intensity (one of three general regimens):
Busulfan (< 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (> 2000 mg/m2 total)
intervention type: Drug
intervention name: Plerixafor
arm group label: Related donors receiving plerixafor
other name: Mozobil
other name: AMD3000
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Steve Devine, MD
role: Principal Investigator
affiliation: NMDP/BeTheMatch
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
mesh term: Leukemia, Myeloid, Acute
mesh term: Hodgkin Disease
mesh term: Myelodysplastic Syndromes
mesh term: Plerixafor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Although this was a prospective multicenter trial, conclusions are limited by the single arm design and small sample size.
point of contact: 