<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/NCT03016806</url>
  </required_header>
  <id_info>
    <org_study_id>UBMT 15029</org_study_id>
    <nct_id>NCT03016806</nct_id>
  </id_info>
  <brief_title>Umbilical Cord Blood Transplantation From Unrelated Donors</brief_title>
  <official_title>Umbilical Cord Blood Transplantation From Unrelated Donors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a single-center, treatment protocol with 4 possible preparative regimens,&#xD;
      designed to validate the process of umbilical cord blood stem cell transplantation at our&#xD;
      institution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a single-center treatment protocol with four possible preparative regimens,&#xD;
      designed to validate the process of umbilical cord blood stem cell transplantation at our&#xD;
      institution. Enrolled patients will receive chemotherapy +/-total body radiation as a&#xD;
      pre-transplant conditioning regimen. Patients will then receive cord blood stem cells&#xD;
      followed by GvHD prophylaxis that will include Tacrolimus and Mycophenolate Mofetil, or&#xD;
      Cyclosporin A and Methylprednisolone. Multiple data points will be collected prior to,&#xD;
      during, and following transplantation to ensure safety of the process and to evaluate the&#xD;
      stated objectives.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Anticipated">June 2026</completion_date>
  <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
  <phase>Phase 1</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>Engraftment of ANC and Platelets</measure>
    <time_frame>42 days following the infusion of stem cells for ANC [If engraftment of ANC does not occur within 42 days, a subsequent transplant will be performed if a donor is available.]</time_frame>
    <description>The date of engraftment of ANC is the first of 3 consecutive days of ANC of 500 or higher based on daily CBC and Differential Counts. The date of engraftment of platelets is the first of three consecutive days of platelet counts of 20,000 or higher in the absence of platelet transfusions for a t least 7 days prior.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of non-engraftment and of secondary graft failure</measure>
    <time_frame>At 30 days, 100 days, 6 months and yearly from the date of transplant until the date of documented graft failure or the subject's death up to 120 months.</time_frame>
    <description>The percentage of patients who fail to initially engraft ANC will be tabulated as well as the percentage of patients who have primary engraftment of ANC but whose graft fails as evidenced by pancytopenia, failure of bone marrow function and loss of donor chimerism following initial engraftment of ANC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of acute graft-versus-host disease</measure>
    <time_frame>At 30 days and 100 days after transplant from the date of transplant until the date of documented acute GvHD.</time_frame>
    <description>Routine physical exams, liver function tests, and clinical history of diarrhea and upper GI symptoms will be used to assess the presence of, the maximum severity of and the date of onset of Acute GvHD based on the criteria published by Przepioka et al., Bone Marrow Transplant 1995; 15(6):825-8 as used by the Center for International Blood &amp; Marrow Transplant Research. The percentage of patients developing symptoms of acute graft-versus-host disease will be tabulated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of chronic graft-versus-host disease</measure>
    <time_frame>At 100 days, 6 months and yearly after transplant from the date of transplant until the date of documented graft failure or the subject's death up to 120 months.</time_frame>
    <description>Assess the presence of and the maximum severity of and the date of onset of chronic GvHD based on Sullivan KM, Blood 1981;57-267 as used by the Cneter for International Blood &amp; Marrow Transplant Research.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>At 30 days, 100 days, 6 months and yearly after transplant from the date of transplant until the date of documented graft failure or the subject's death up to 120 months.</time_frame>
    <description>Document and update the length of time a subject survives without recurrence of the disease for which they were transplanted at 30 days, 100 days, 6 months and yearly following the infusion of cord blood stem cells for as long as the subjects survive and remain disease-free.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Acute Leukemia</condition>
  <condition>Immune Deficiency Disorder</condition>
  <condition>Congenital Hematological Disorder</condition>
  <condition>Metabolism Disorder</condition>
  <condition>Aplastic Anemia</condition>
  <condition>Myelodysplastic Syndromes</condition>
  <condition>Chronic Leukemia</condition>
  <condition>Lymphoma</condition>
  <condition>Multiple Myeloma</condition>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>Full Intensity, TBI-based Conditioning</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Full Intensity TBI-based Conditioning Total Body Irradiation 1200 cGy in fractions of 150 cGy days -8 or -7 to -4 Cyclophosphamide 60 mg/kg/day x 2 doses days -3 and -2 Mesna 60 mg/kg/day with 20% loading dose with first Cyclophosphamide followed by continuous infusion over 24 hours x 2 doses [to be completed 24 hours after final Cyclophosphamide dose] followed by Cord Blood Infusion Other names: TBI/Cy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Full Intensity, Chemo-based Conditioning</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Full Intensity, Chemotherapy Conditioning Busulfan days -7 to -4 Recipients &lt;5 years - 1 mg/kg/dose x 16 doses every 6 hours Recipients &gt;/= 5 years - 0.8 mg/kg/dose x 16 doses every 6 hours Cyclophosphamide 60 mg/kg/day x 2 doses days -3 and -2 Mesna 60 mg/kg/day with 20% loading dose with first Cyclophosphamide followed by continuous infusion over 24 hours x 2 doses [to be completed 24 hours after final Cyclophosphamide dose] followed by Cord Blood Infusion Other names: Bu/Cy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reduced Intensity Chemotherapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Reduced Intensity Chemotherapy Fludarabine 30 mg/m2/day x 5 doses days -6 to -2 Melphalan 140 mg/m2/day x 1 dose day -2 Cord Blood Infusion Other names: Flu/Mel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Myeloablative Conditioning</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Fludarabine 40 mg/m2/day x 5 doses days -6 to -2 Cyclophosphamide 50 mg/kg/day x 1 dose day -6 Mesna 50 mg/kg/day with 20% loading dose with Cyclophosphamide dose followed by continuous infusion over 24 hours x 1 dose [to be completed 24 hours after Cyclophosphamide dose] Total Body Irradiation 200 cGy in a single fraction day -1 Cord Blood Infusion Other names: Flu/Cy/TBI</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Total Body Irradiation 1200 cGy</intervention_name>
    <description>Total Body Irradiation 1200 cGy in 8 fractions</description>
    <arm_group_label>Full Intensity, TBI-based Conditioning</arm_group_label>
    <other_name>TBI 1200 cGy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Total Body Irradiation 200 cGy</intervention_name>
    <description>Total Body Irradiation 200 cGy in one fraction</description>
    <arm_group_label>Non-Myeloablative Conditioning</arm_group_label>
    <other_name>TBI 200 cGy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>50 mg/kg or 60 mg/kg</description>
    <arm_group_label>Full Intensity, Chemo-based Conditioning</arm_group_label>
    <arm_group_label>Full Intensity, TBI-based Conditioning</arm_group_label>
    <arm_group_label>Non-Myeloablative Conditioning</arm_group_label>
    <other_name>Cy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mesna</intervention_name>
    <description>50 mg/kg or 60 mg/kg plus 10% loading dose</description>
    <arm_group_label>Full Intensity, Chemo-based Conditioning</arm_group_label>
    <arm_group_label>Full Intensity, TBI-based Conditioning</arm_group_label>
    <arm_group_label>Non-Myeloablative Conditioning</arm_group_label>
    <other_name>Pre-Mesna</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cord Blood Infusion</intervention_name>
    <description>Intravenous infusion of cord blood stem cells</description>
    <arm_group_label>Full Intensity, Chemo-based Conditioning</arm_group_label>
    <arm_group_label>Full Intensity, TBI-based Conditioning</arm_group_label>
    <arm_group_label>Reduced Intensity Chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Busulfan</intervention_name>
    <description>0.8 mg/kg x 16 doses</description>
    <arm_group_label>Full Intensity, Chemo-based Conditioning</arm_group_label>
    <other_name>Bu</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fludarabine</intervention_name>
    <description>30 mg/m2/day x 5 or 40 mg/m2/day x 5</description>
    <arm_group_label>Non-Myeloablative Conditioning</arm_group_label>
    <arm_group_label>Reduced Intensity Chemotherapy</arm_group_label>
    <other_name>Flu</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melphalan</intervention_name>
    <description>140 mg/m2</description>
    <arm_group_label>Reduced Intensity Chemotherapy</arm_group_label>
    <other_name>Mel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Appropriate diagnosis: Patients must have a disease or syndrome amenable to therapy&#xD;
             with hematopoietic stem cell transplantation. Diagnoses include, but are not limited&#xD;
             to:&#xD;
&#xD;
          -  Congenital and Other Non-malignant Disorders:&#xD;
&#xD;
          -  Immunodeficiency disorders (e.g. Severe Combined Immunodeficiency, Wiskott-Aldrich&#xD;
             Syndrome)&#xD;
&#xD;
          -  Congenital hematopoietic stem cell defects (e.g. Chediak-Higashi Syndrome, Congenital&#xD;
             Osteopetrosis, Osteogenesis Imperfecta)&#xD;
&#xD;
          -  Metabolic disorders (e.g. Hurler's Syndrome)&#xD;
&#xD;
          -  Severe aplastic anemia&#xD;
&#xD;
          -  High-Risk Leukemia:&#xD;
&#xD;
          -  Acute Myelogenous Leukemia&#xD;
&#xD;
          -  Refractory to standard induction therapy (more than 1 cycle required to achieve&#xD;
             remission)&#xD;
&#xD;
               -  Recurrent (in CR ≥ 2)&#xD;
&#xD;
               -  Treatment-related AML or MDS&#xD;
&#xD;
               -  Evolved from myelodysplastic syndrome&#xD;
&#xD;
               -  Presence of FLT3 abnormalities&#xD;
&#xD;
               -  FAB M6 or M7&#xD;
&#xD;
               -  Adverse cytogenetics&#xD;
&#xD;
               -  Myelodysplastic Syndrome&#xD;
&#xD;
               -  Acute Lymphoblastic Leukemia including T lymphoblastic leukemia:&#xD;
&#xD;
               -  Refractory to standard induction therapy (time to CR &gt;4 weeks)&#xD;
&#xD;
               -  Recurrent (in CR ≥ 2)&#xD;
&#xD;
               -  WBC count &gt;30,000/mcL at diagnosis&#xD;
&#xD;
               -  Age &gt;30 at diagnosis&#xD;
&#xD;
          -  Adverse cytogenetics, such as t(9:22), t(1:19), t(4:11), and other MLL rearrangements.&#xD;
&#xD;
          -  Chronic Myelogenous Leukemia in accelerated phase or blast crisis&#xD;
&#xD;
          -  Biphenotypic or undifferentiated leukemia&#xD;
&#xD;
          -  Burkitt's leukemia or lymphoma&#xD;
&#xD;
          -  Lymphoma:&#xD;
&#xD;
          -  Large cell, Mantle cell, Hodgkin lymphoma refractory or recurrent, chemo-sensitive,&#xD;
             and ineligible for an autologous stem cell transplant or previously treated with&#xD;
             autologous SCT&#xD;
&#xD;
          -  Marginal zone or follicular lymphoma that is progressive after at least two prior&#xD;
             therapies&#xD;
&#xD;
          -  Multiple Myeloma, recurrent following high-dose therapy and autologous SCT or&#xD;
             ineligible for an autologous HSCT&#xD;
&#xD;
          -  Solid tumors, with efficacy of allogeneic HSCT demonstrated for the specific disease&#xD;
             and disease status&#xD;
&#xD;
          -  Adequate organ function:&#xD;
&#xD;
          -  Cardiac - LVEF &gt;45%, or shortening fraction &gt;25%, Absence of congestive heart failure&#xD;
             or conduction disturbances with high risk for sudden death&#xD;
&#xD;
          -  Pulmonary - DLCO (corrected for hemoglobin), FEV1 and FVC ≥ 50% predicted;&#xD;
&#xD;
          -  Renal - serum Cr &lt; 1.5 times the upper limit of normal for age or GFR ≥ 50&#xD;
             ml/min/1.73m2&#xD;
&#xD;
          -  Hepatic - total bilirubin level &lt; 2 times the upper limit of normal (except for&#xD;
             patients with Gilbert's syndrome or hemolysis); if the primary disease process is&#xD;
             causal, this criterion will be reconsidered. ALT, AST, and Alkaline phosphatase ≤ 5&#xD;
             times upper limit of normal.&#xD;
&#xD;
          -  Performance Status Karnofsky or Lansky score ≥ 70%.&#xD;
&#xD;
          -  Informed Consent must be obtained prior to initiating conditioning therapy.&#xD;
&#xD;
          -  Receipt of viable cord blood product(s), single or dual, must be confirmed with the&#xD;
             stem cell processing laboratory prior to initiating conditioning therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Availability of 10/10 or 9/10 HLA-matched related or unrelated donor within a&#xD;
             reasonable timeframe dictated by the clinical urgency of the transplant&#xD;
&#xD;
          -  Autologous HSCT &lt; 6 months prior to proposed UCB transplant&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Current uncontrolled infection&#xD;
&#xD;
          -  Evidence of HIV infection or positive HIV serology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jane L Liesveld, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Director, Blood &amp; Marrow Transplant Unit</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jane L Liesveld, MD</last_name>
    <phone>585-275-4099</phone>
    <email>jane_liesveld@urmc.rochester.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael W Becker, MD</last_name>
    <phone>585-275-4099</phone>
    <email>michael_becker@urmc.rochester.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Wilmot Cancer Institute</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jane L Liesveld, MD</last_name>
      <phone>585-275-4099</phone>
      <email>jane_liesveld@urmc.rochester.edu</email>
    </contact>
    <contact_backup>
      <last_name>Michael W Becker, MD</last_name>
      <phone>585-275-4099</phone>
      <email>michael_becker@urmc.rochester.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>January 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>July 17, 2023</last_update_submitted>
  <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Jane Liesveld</investigator_full_name>
    <investigator_title>Clinical Director, BMT Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Anemia, Aplastic</mesh_term>
    <mesh_term>Hematologic Diseases</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Melphalan</mesh_term>
    <mesh_term>Busulfan</mesh_term>
    <mesh_term>Fludarabine</mesh_term>
    <mesh_term>Mesna</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03016806
org study id: UBMT 15029
nct id: NCT03016806
lead sponsor: 
has dmc: Yes
This study is a single-center, treatment protocol with 4 possible preparative regimens,
      designed to validate the process of umbilical cord blood stem cell transplantation at our
      institution.
This study is a single-center treatment protocol with four possible preparative regimens,
      designed to validate the process of umbilical cord blood stem cell transplantation at our
      institution. Enrolled patients will receive chemotherapy +/-total body radiation as a
      pre-transplant conditioning regimen. Patients will then receive cord blood stem cells
      followed by GvHD prophylaxis that will include Tacrolimus and Mycophenolate Mofetil, or
      Cyclosporin A and Methylprednisolone. Multiple data points will be collected prior to,
      during, and following transplantation to ensure safety of the process and to evaluate the
      stated objectives.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Engraftment of ANC and Platelets
time frame: 42 days following the infusion of stem cells for ANC [If engraftment of ANC does not occur within 42 days, a subsequent transplant will be performed if a donor is available.]
description: The date of engraftment of ANC is the first of 3 consecutive days of ANC of 500 or higher based on daily CBC and Differential Counts. The date of engraftment of platelets is the first of three consecutive days of platelet counts of 20,000 or higher in the absence of platelet transfusions for a t least 7 days prior.
measure: Rate of non-engraftment and of secondary graft failure
time frame: At 30 days, 100 days, 6 months and yearly from the date of transplant until the date of documented graft failure or the subject's death up to 120 months.
description: The percentage of patients who fail to initially engraft ANC will be tabulated as well as the percentage of patients who have primary engraftment of ANC but whose graft fails as evidenced by pancytopenia, failure of bone marrow function and loss of donor chimerism following initial engraftment of ANC.
measure: Incidence of acute graft-versus-host disease
time frame: At 30 days and 100 days after transplant from the date of transplant until the date of documented acute GvHD.
description: Routine physical exams, liver function tests, and clinical history of diarrhea and upper GI symptoms will be used to assess the presence of, the maximum severity of and the date of onset of Acute GvHD based on the criteria published by Przepioka et al., Bone Marrow Transplant 1995; 15(6):825-8 as used by the Center for International Blood & Marrow Transplant Research. The percentage of patients developing symptoms of acute graft-versus-host disease will be tabulated.
measure: Incidence of chronic graft-versus-host disease
time frame: At 100 days, 6 months and yearly after transplant from the date of transplant until the date of documented graft failure or the subject's death up to 120 months.
description: Assess the presence of and the maximum severity of and the date of onset of chronic GvHD based on Sullivan KM, Blood 1981;57-267 as used by the Cneter for International Blood & Marrow Transplant Research.
measure: Disease-free survival
time frame: At 30 days, 100 days, 6 months and yearly after transplant from the date of transplant until the date of documented graft failure or the subject's death up to 120 months.
description: Document and update the length of time a subject survives without recurrence of the disease for which they were transplanted at 30 days, 100 days, 6 months and yearly following the infusion of cord blood stem cells for as long as the subjects survive and remain disease-free.
arm group label: Full Intensity, TBI-based Conditioning
arm group type: Other
description: Full Intensity TBI-based Conditioning Total Body Irradiation 1200 cGy in fractions of 150 cGy days -8 or -7 to -4 Cyclophosphamide 60 mg/kg/day x 2 doses days -3 and -2 Mesna 60 mg/kg/day with 20% loading dose with first Cyclophosphamide followed by continuous infusion over 24 hours x 2 doses [to be completed 24 hours after final Cyclophosphamide dose] followed by Cord Blood Infusion Other names: TBI/Cy
arm group label: Full Intensity, Chemo-based Conditioning
arm group type: Other
description: Full Intensity, Chemotherapy Conditioning Busulfan days -7 to -4 Recipients <5 years - 1 mg/kg/dose x 16 doses every 6 hours Recipients >/= 5 years - 0.8 mg/kg/dose x 16 doses every 6 hours Cyclophosphamide 60 mg/kg/day x 2 doses days -3 and -2 Mesna 60 mg/kg/day with 20% loading dose with first Cyclophosphamide followed by continuous infusion over 24 hours x 2 doses [to be completed 24 hours after final Cyclophosphamide dose] followed by Cord Blood Infusion Other names: Bu/Cy
arm group label: Reduced Intensity Chemotherapy
arm group type: Other
description: Reduced Intensity Chemotherapy Fludarabine 30 mg/m2/day x 5 doses days -6 to -2 Melphalan 140 mg/m2/day x 1 dose day -2 Cord Blood Infusion Other names: Flu/Mel
arm group label: Non-Myeloablative Conditioning
arm group type: Other
description: Fludarabine 40 mg/m2/day x 5 doses days -6 to -2 Cyclophosphamide 50 mg/kg/day x 1 dose day -6 Mesna 50 mg/kg/day with 20% loading dose with Cyclophosphamide dose followed by continuous infusion over 24 hours x 1 dose [to be completed 24 hours after Cyclophosphamide dose] Total Body Irradiation 200 cGy in a single fraction day -1 Cord Blood Infusion Other names: Flu/Cy/TBI
intervention type: Radiation
intervention name: Total Body Irradiation 1200 cGy
description: Total Body Irradiation 1200 cGy in 8 fractions
arm group label: Full Intensity, TBI-based Conditioning
other name: TBI 1200 cGy
intervention type: Radiation
intervention name: Total Body Irradiation 200 cGy
description: Total Body Irradiation 200 cGy in one fraction
arm group label: Non-Myeloablative Conditioning
other name: TBI 200 cGy
intervention type: Drug
intervention name: Cyclophosphamide
description: 50 mg/kg or 60 mg/kg
arm group label: Full Intensity, Chemo-based Conditioning
arm group label: Full Intensity, TBI-based Conditioning
arm group label: Non-Myeloablative Conditioning
other name: Cy
intervention type: Drug
intervention name: Mesna
description: 50 mg/kg or 60 mg/kg plus 10% loading dose
arm group label: Full Intensity, Chemo-based Conditioning
arm group label: Full Intensity, TBI-based Conditioning
arm group label: Non-Myeloablative Conditioning
other name: Pre-Mesna
intervention type: Procedure
intervention name: Cord Blood Infusion
description: Intravenous infusion of cord blood stem cells
arm group label: Full Intensity, Chemo-based Conditioning
arm group label: Full Intensity, TBI-based Conditioning
arm group label: Reduced Intensity Chemotherapy
intervention type: Drug
intervention name: Busulfan
description: 0.8 mg/kg x 16 doses
arm group label: Full Intensity, Chemo-based Conditioning
other name: Bu
intervention type: Drug
intervention name: Fludarabine
description: 30 mg/m2/day x 5 or 40 mg/m2/day x 5
arm group label: Non-Myeloablative Conditioning
arm group label: Reduced Intensity Chemotherapy
other name: Flu
intervention type: Drug
intervention name: Melphalan
description: 140 mg/m2
arm group label: Reduced Intensity Chemotherapy
other name: Mel
criteria: 
gender: All
minimum age: 2 Months
maximum age: 75 Years
healthy volunteers: No
last name: Jane L Liesveld, MD
role: Principal Investigator
affiliation: Medical Director, Blood & Marrow Transplant Unit
last name: Jane L Liesveld, MD
phone: 585-275-4099
email: jane_liesveld@urmc.rochester.edu
last name: Michael W Becker, MD
phone: 585-275-4099
email: michael_becker@urmc.rochester.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Jane Liesveld
investigator title: Clinical Director, BMT Unit
mesh term: Leukemia
mesh term: Multiple Myeloma
mesh term: Myelodysplastic Syndromes
mesh term: Anemia, Aplastic
mesh term: Hematologic Diseases
mesh term: Immunologic Deficiency Syndromes
mesh term: Cyclophosphamide
mesh term: Melphalan
mesh term: Busulfan
mesh term: Fludarabine
mesh term: Mesna