<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/NCT02200380</url>
  </required_header>
  <id_info>
    <org_study_id>CDX301-03</org_study_id>
    <nct_id>NCT02200380</nct_id>
  </id_info>
  <brief_title>A Safety and Tolerability Study of CDX-301 With or Without Plerixafor for Stem Cell Mobilization in Matched Related Allogeneic Donor/Recipient Sibling Transplant Pairs</brief_title>
  <official_title>A Pilot Study of CDX-301 (rhuFlt3L) With or Without Plerixafor for the Mobilization and Transplantation of Allogeneic Blood Cell Grafts in HLA-Matched Donor/Recipient Sibling Pairs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Celldex Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Celldex Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, multicenter, prospective pilot study of CDX-301 with or without&#xD;
      plerixafor as a stem cell mobilizer for allogeneic transplantation (stem cells that come from&#xD;
      another person). HLA-matched sibling healthy volunteers (donors) and patients with protocol&#xD;
      specified hematologic malignancies (recipients) will be enrolled.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">April 13, 2016</completion_date>
  <primary_completion_date type="Actual">March 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability profile of CDX-301 with or without plerixafor in healthy adult sibling stem cell donors.</measure>
    <time_frame>1 Year</time_frame>
    <description>Safety and tolerability will be evaluated by comparing the treatment regimens in regards to vital sign measurements, physical examinations and adverse event reporting.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of donors whose stem cells can be successfully mobilized and collected with a sufficient CD34+ cell count using CDX-301 with or without plerixafor as the mobilizing agent.</measure>
    <time_frame>Day 6 - Day 12</time_frame>
    <description>Donor mobilization will be considered successful if ≥ 2 million CD34+ cells/kg recipient weight are collected in no more than two leukapheresis collections.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe the cellular composition of allografts mobilized with CDX-301 with or without plerixafor (stem/progenitor cells, T/B/NK-cells).</measure>
    <time_frame>Day 6 - Day 12</time_frame>
    <description>To describe the cellular composition of allografts mobilized with CDX-301 with or without plerixafor (stem/progenitor cells, T/B/NK-cells).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of and kinetics of neutrophil and platelet recovery after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor</measure>
    <time_frame>Day 21, Day 28, Day 56, Day 100, Day 180, Day 270, Day 365.</time_frame>
    <description>To determine the incidence of and kinetics of neutrophil, and platelet recovery after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of primary and secondary graft failure after transplantation of hematopoietic cells mobilized with CDX301-03 with or without plerixafor.</measure>
    <time_frame>Day 28, Day 100, Day 180, Day 365.</time_frame>
    <description>To determine the incidence of primary and secondary graft failure after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.</measure>
    <time_frame>Day 28, 100, 180, 365.</time_frame>
    <description>To assess the rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of acute and chronic graft-versus host disease (GVHD) after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.</measure>
    <time_frame>Day 28, Day 56, Day 100, Day 180, Day 270, Day 365.</time_frame>
    <description>To determine the incidence of acute and chronic graft-versus host disease (GVHD) after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of CMV reactivation after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor in transplant recipients.</measure>
    <time_frame>Day 28, Day 56, Day 100, Day 180, Day 270, Day 365.</time_frame>
    <description>To determine the incidence of CMV reactivation after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor in transplant recipients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of post-transplant days of hospitalization in patients that received hematopoietic cells mobilized with CDX-301 with or without plerixafor.</measure>
    <time_frame>Day 21, 28, 56, 100, 180, 270, 365</time_frame>
    <description>To determine the number of post transplant days of hospitalization after receiving hematopoietic cells mobilized with CDX-301 with or without plerixafor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-related mortality and disease relapse/progression after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.</measure>
    <time_frame>Day 21, 28, 56, 100, 180, 270, 365.</time_frame>
    <description>To determine the incidence of treatment-related mortality and disease relapse/progression after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>For Donors</condition>
  <condition>Related Donors Giving Peripheral Blood Stem Cells (PBSC) to a Sibling</condition>
  <condition>For Recipients</condition>
  <condition>Acute Myelogenous Leukemia (AML)</condition>
  <condition>Acute Lymphoblastic Leukemia (ALL)</condition>
  <condition>Myelodysplastic Syndrome (MDS)</condition>
  <condition>Chronic Myelogenous Leukemia (CML)</condition>
  <condition>Non-Hodgkins Lymphoma (NHL)</condition>
  <condition>Hodgkins Disease (HD)</condition>
  <condition>Chronic Lymphocytic Leukemia (CLL)</condition>
  <arm_group>
    <arm_group_label>CDX-301</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CDX-301 and plerixafor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CDX-301</intervention_name>
    <description>Related donors will receive CDX-301 for 5 days or 7 days.</description>
    <arm_group_label>CDX-301</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CDX-301 and plerixafor</intervention_name>
    <description>Related donors will receive CDX-301 for 5 or 7 days plus plerixafor.</description>
    <arm_group_label>CDX-301 and plerixafor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Donors:&#xD;
&#xD;
          -  Read, understood and provided written informed consent and willing to comply with all&#xD;
             study requirements and procedures&#xD;
&#xD;
          -  6 out of 6 HLA-matched sibling&#xD;
&#xD;
          -  Negative test for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C&#xD;
&#xD;
          -  Both male and female patients of childbearing potential enrolled in this trial must&#xD;
             use adequate birth control measures&#xD;
&#xD;
          -  Subjects should be in generally good health and without significant medical&#xD;
             conditions, based upon pre-study medical history, physical examination,&#xD;
             electrocardiogram (ECG), chest X- ray, and laboratory tests&#xD;
&#xD;
          -  Meets all criteria to serve as a mobilized blood cell donor in accordance with all&#xD;
             applicable individual Transplant Center criteria&#xD;
&#xD;
        Recipient:&#xD;
&#xD;
          -  Read, understood and provided written informed consent and willing to comply with all&#xD;
             study requirements and procedures&#xD;
&#xD;
          -  6 out of 6 HLA-matched sibling&#xD;
&#xD;
          -  Both male and female patients of childbearing potential enrolled in this trial must&#xD;
             use adequate birth control measures&#xD;
&#xD;
        Diagnosis of one of following:&#xD;
&#xD;
          -  Acute Myelogenous Leukemia (AML) in 1st remission or beyond&#xD;
&#xD;
          -  Acute Lymphoblastic Leukemia (ALL) in 1st remission or beyond&#xD;
&#xD;
          -  Chronic Myelogenous Leukemia (CML)&#xD;
&#xD;
          -  Chronic Lymphoblastic Leukemia (CLL), relapsing after at least one prior regimen&#xD;
&#xD;
          -  Myelodysplastic Syndrome (MDS), either intermediate 1,2, or high risk by IPI Scoring&#xD;
             System or transfusion dependent&#xD;
&#xD;
          -  Non-Hodgkins Lymphoma (NHL) or Hodgkins Disease (HD) in 2nd or greater complete&#xD;
             remission, partial remission, or in relapse&#xD;
&#xD;
          -  Meets all criteria to serve as a transplant recipient in accordance with all&#xD;
             applicable individual Transplant Center criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Donors:&#xD;
&#xD;
          -  Unwilling or unable to give informed consent, or unable to comply with the protocol&#xD;
             including required follow-up and testing&#xD;
&#xD;
          -  Prior treatment with any rhuFlt3L product&#xD;
&#xD;
          -  Any vaccination within 4 weeks prior to CDX-301 dosing&#xD;
&#xD;
          -  Donation of blood within 8 weeks, or donation of plasma within 2 weeks prior to&#xD;
             CDX-301 dosing&#xD;
&#xD;
          -  Any experimental treatment within 4 weeks prior to CDX-301 dosing&#xD;
&#xD;
          -  Use of systemic immunosuppressive agents (excluding topical steroids) within 12 months&#xD;
             prior to CDX-301 dosing.&#xD;
&#xD;
          -  History of first degree relatives with primary or secondary immunodeficiency to&#xD;
             include type 1 diabetes, multiple sclerosis, rheumatoid arthritis, scleroderma or&#xD;
             psoriasis&#xD;
&#xD;
          -  History of tuberculosis infection&#xD;
&#xD;
          -  Herpes zoster within 3 months prior to starting study drug&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
        Recipient:&#xD;
&#xD;
          -  Unwilling or unable to give informed consent, or unable to comply with the protocol&#xD;
             including required follow-up and testing&#xD;
&#xD;
          -  Prior allogeneic transplant&#xD;
&#xD;
          -  More than one prior autologous transplant&#xD;
&#xD;
          -  Prior treatment with any rhuFlt3L product&#xD;
&#xD;
          -  Any vaccination within 4 weeks prior to transplant&#xD;
&#xD;
          -  Uncontrolled infection at the time of the transplant conditioning regimen&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Any condition, which, in the opinion of the clinical investigator, would interfere&#xD;
             with the evaluation of the study outcome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University-Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana Blood and Marrow Transplant</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Arthur G. James Cancer Hospital and Richard J. Solove Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Medical Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University Medical Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>June 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <disposition_first_submitted>April 6, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>April 6, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 7, 2017</disposition_first_posted>
  <last_update_submitted>April 6, 2017</last_update_submitted>
  <last_update_submitted_qc>April 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2017</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>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Preleukemia</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>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02200380
org study id: CDX301-03
nct id: NCT02200380
lead sponsor: 
has dmc: No
This is an open-label, multicenter, prospective pilot study of CDX-301 with or without
      plerixafor as a stem cell mobilizer for allogeneic transplantation (stem cells that come from
      another person). HLA-matched sibling healthy volunteers (donors) and patients with protocol
      specified hematologic malignancies (recipients) will be enrolled.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability profile of CDX-301 with or without plerixafor in healthy adult sibling stem cell donors.
time frame: 1 Year
description: Safety and tolerability will be evaluated by comparing the treatment regimens in regards to vital sign measurements, physical examinations and adverse event reporting.
measure: The proportion of donors whose stem cells can be successfully mobilized and collected with a sufficient CD34+ cell count using CDX-301 with or without plerixafor as the mobilizing agent.
time frame: Day 6 - Day 12
description: Donor mobilization will be considered successful if ≥ 2 million CD34+ cells/kg recipient weight are collected in no more than two leukapheresis collections.
measure: Describe the cellular composition of allografts mobilized with CDX-301 with or without plerixafor (stem/progenitor cells, T/B/NK-cells).
time frame: Day 6 - Day 12
description: To describe the cellular composition of allografts mobilized with CDX-301 with or without plerixafor (stem/progenitor cells, T/B/NK-cells).
measure: Incidence of and kinetics of neutrophil and platelet recovery after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor
time frame: Day 21, Day 28, Day 56, Day 100, Day 180, Day 270, Day 365.
description: To determine the incidence of and kinetics of neutrophil, and platelet recovery after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.
measure: Incidence of primary and secondary graft failure after transplantation of hematopoietic cells mobilized with CDX301-03 with or without plerixafor.
time frame: Day 28, Day 100, Day 180, Day 365.
description: To determine the incidence of primary and secondary graft failure after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.
measure: Rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.
time frame: Day 28, 100, 180, 365.
description: To assess the rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.
measure: Incidence of acute and chronic graft-versus host disease (GVHD) after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.
time frame: Day 28, Day 56, Day 100, Day 180, Day 270, Day 365.
description: To determine the incidence of acute and chronic graft-versus host disease (GVHD) after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.
measure: Incidence of CMV reactivation after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor in transplant recipients.
time frame: Day 28, Day 56, Day 100, Day 180, Day 270, Day 365.
description: To determine the incidence of CMV reactivation after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor in transplant recipients.
measure: Number of post-transplant days of hospitalization in patients that received hematopoietic cells mobilized with CDX-301 with or without plerixafor.
time frame: Day 21, 28, 56, 100, 180, 270, 365
description: To determine the number of post transplant days of hospitalization after receiving hematopoietic cells mobilized with CDX-301 with or without plerixafor.
measure: Incidence of treatment-related mortality and disease relapse/progression after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.
time frame: Day 21, 28, 56, 100, 180, 270, 365.
description: To determine the incidence of treatment-related mortality and disease relapse/progression after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.
arm group label: CDX-301
arm group type: Experimental
arm group label: CDX-301 and plerixafor
arm group type: Experimental
intervention type: Drug
intervention name: CDX-301
description: Related donors will receive CDX-301 for 5 days or 7 days.
arm group label: CDX-301
intervention type: Drug
intervention name: CDX-301 and plerixafor
description: Related donors will receive CDX-301 for 5 or 7 days plus plerixafor.
arm group label: CDX-301 and plerixafor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Lymphoma, Non-Hodgkin
mesh term: Preleukemia
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