Non-Myeloablative Conditioning for Unrelated Donor Umbilical Cord Blood Transplant

Sponsor
Masonic Cancer Center, University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT00305682
Collaborator
(none)
295
Enrollment
1
Location
6
Arms
174.4
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. An umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving sirolimus and mycophenolate mofetil after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by an umbilical cord blood transplant, sirolimus, and mycophenolate mofetil works in treating patients with hematologic cancer.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Detailed Description

OBJECTIVES:

Primary

  • Determine the one- and two-year survival of patients with hematologic malignancies treated with a nonmyeloablative conditioning regimen comprising fludarabine, cyclophosphamide, and total-body irradiation followed by umbilical cord blood transplantation and post-transplant immunosuppression comprising sirolimus and mycophenolate mofetil.

Secondary

  • Determine the six-month nonrelapse mortality of patients treated with this regimen.

  • Determine the presence of chimerism in patients treated with this regimen at days 21, 60, 100, 180, and 365.

  • Determine the incidence of neutrophil engraftment by day 42 in patients treated with this regimen.

  • Determine the incidence of platelet engraftment by six months in patients treated with this regimen.

  • Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 in patients treated with this regimen.

  • Determine the incidence of chronic GVHD at one year in patients treated with this regimen.

  • Determine the probability of overall survival within one or two years in patients treated with this regimen.

  • Determine the probability of progression-free survival within one or two years in patients treated with this regimen.

  • Determine the incidence of relapse or disease progression within one or two years in patients treated with this regimen.

OUTLINE: This is a nonrandomized study. Patients are stratified into five disease groups: 1. acute myeloid leukemia, myelodysplastic syndromes, chronic myelogenous leukemia [CML] in first chronic phase and second chronic phase [CP2] after myeloid blast crisis; 2. acute lymphoblastic leukemia, Burkitt's lymphoma, CML CP2 post lymphoid blast crisis, 3. large-cell B and T-cell lymphoma, mantle cell lymphoma; 4. chronic lymphocytic leukemia/small lymphocytic lymphoma, prolymphocytic leukemia, marginal zone B-cell lymphoma, follicular lymphoma; 5. Hodgkin's lymphoma and multiple myeloma.

  • Nonmyeloablative conditioning: Patients receive fludarabine intravenously on days -6 to -2 and cyclophosphamide IV on day -6. Patients who did not undergo prior autologous transplant or who received ≤ 1 course of prior multiagent chemotherapy or no severely immunosuppressive therapy in the past 3 months also receive anti-thymocyte globulin IV on days -6 to -4. All patients also undergo total-body irradiation on day -1.

  • Umbilical cord blood transplant: Patients undergo umbilical cord blood transplantation on day 0.

  • Post-transplant immunosuppression: Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL. Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation. Patients also receive mycophenolate mofetil IV on days -3 to 5 and then orally on days 6-30.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 320 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
295 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Non-Myeloablative Preparative Regimen
Actual Study Start Date :
Jun 1, 2005
Actual Primary Completion Date :
Dec 12, 2019
Actual Study Completion Date :
Dec 12, 2019

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Arm 1-Previous Autologous Transplant

Arm 1 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.

Drug: cyclophosphamide
Cyclophosphamide 50mg/kg x 1 to be administered IV over 2 hours with high volume fluid flush on day -6.
Other Names:
  • Cytoxan
  • Drug: Fludarabine
    Fludarabine 40 mg/m2/day or 30 mg/m2/day intravenously (IV) as one hour infusion x 5 days, on day -6 to -2.
    Other Names:
  • Fludara
  • Drug: mycophenolate mofetil
    Mycophenolate mofetil (MMF) 3 gram/day for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours.
    Other Names:
  • MMF
  • Procedure: umbilical cord blood transplantation
    One or 2 UCB units may be infused to achieve the required cell dose.
    Other Names:
  • UCBT
  • Radiation: total body irradiation
    Administered Day -1, 200 cGy
    Other Names:
  • TBI
  • Drug: Sirolimus
    Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL. Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation.
    Other Names:
  • rapamycin
  • Active Comparator: Arm 2 - No Prior Autologous Transplant

    Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.

    Biological: anti-thymocyte globulin
    Equine ATG dose is 15 mg/kg intravenously (IV) every 12 hours for 6 doses on days -6, - 5, and -4.
    Other Names:
  • ATGAM
  • ATG
  • Drug: cyclophosphamide
    Cyclophosphamide 50mg/kg x 1 to be administered IV over 2 hours with high volume fluid flush on day -6.
    Other Names:
  • Cytoxan
  • Drug: Fludarabine
    Fludarabine 40 mg/m2/day or 30 mg/m2/day intravenously (IV) as one hour infusion x 5 days, on day -6 to -2.
    Other Names:
  • Fludara
  • Drug: mycophenolate mofetil
    Mycophenolate mofetil (MMF) 3 gram/day for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours.
    Other Names:
  • MMF
  • Procedure: umbilical cord blood transplantation
    One or 2 UCB units may be infused to achieve the required cell dose.
    Other Names:
  • UCBT
  • Radiation: total body irradiation
    Administered Day -1, 200 cGy
    Other Names:
  • TBI
  • Drug: Sirolimus
    Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL. Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation.
    Other Names:
  • rapamycin
  • Active Comparator: Arm 3 - Refractory Leukemia/Lymphoma

    Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.

    Biological: anti-thymocyte globulin
    Equine ATG dose is 15 mg/kg intravenously (IV) every 12 hours for 6 doses on days -6, - 5, and -4.
    Other Names:
  • ATGAM
  • ATG
  • Drug: cyclophosphamide
    Cyclophosphamide 50mg/kg x 1 to be administered IV over 2 hours with high volume fluid flush on day -6.
    Other Names:
  • Cytoxan
  • Drug: Fludarabine
    Fludarabine 40 mg/m2/day or 30 mg/m2/day intravenously (IV) as one hour infusion x 5 days, on day -6 to -2.
    Other Names:
  • Fludara
  • Drug: mycophenolate mofetil
    Mycophenolate mofetil (MMF) 3 gram/day for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours.
    Other Names:
  • MMF
  • Procedure: umbilical cord blood transplantation
    One or 2 UCB units may be infused to achieve the required cell dose.
    Other Names:
  • UCBT
  • Radiation: total body irradiation
    Administered Day -1, 200 cGy
    Other Names:
  • TBI
  • Drug: Sirolimus
    Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL. Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation.
    Other Names:
  • rapamycin
  • Active Comparator: Arm 4: MT2006-01 coenrolling patients

    Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.

    Drug: cyclophosphamide
    Cyclophosphamide 50mg/kg x 1 to be administered IV over 2 hours with high volume fluid flush on day -6.
    Other Names:
  • Cytoxan
  • Drug: Fludarabine
    Fludarabine 40 mg/m2/day or 30 mg/m2/day intravenously (IV) as one hour infusion x 5 days, on day -6 to -2.
    Other Names:
  • Fludara
  • Drug: mycophenolate mofetil
    Mycophenolate mofetil (MMF) 3 gram/day for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours.
    Other Names:
  • MMF
  • Procedure: umbilical cord blood transplantation
    One or 2 UCB units may be infused to achieve the required cell dose.
    Other Names:
  • UCBT
  • Radiation: total body irradiation
    Administered Day -1, 200 cGy
    Other Names:
  • TBI
  • Drug: Sirolimus
    Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL. Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation.
    Other Names:
  • rapamycin
  • Active Comparator: Arm 5 - Previous Autologous Transplant

    Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.

    Drug: cyclophosphamide
    Cyclophosphamide 50mg/kg x 1 to be administered IV over 2 hours with high volume fluid flush on day -6.
    Other Names:
  • Cytoxan
  • Drug: Fludarabine
    Fludarabine 40 mg/m2/day or 30 mg/m2/day intravenously (IV) as one hour infusion x 5 days, on day -6 to -2.
    Other Names:
  • Fludara
  • Drug: mycophenolate mofetil
    Mycophenolate mofetil (MMF) 3 gram/day for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours.
    Other Names:
  • MMF
  • Procedure: umbilical cord blood transplantation
    One or 2 UCB units may be infused to achieve the required cell dose.
    Other Names:
  • UCBT
  • Radiation: total body irradiation
    Administered Day -1, 200 cGy
    Other Names:
  • TBI
  • Drug: Sirolimus
    Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL. Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation.
    Other Names:
  • rapamycin
  • Active Comparator: Arm 6 - No prior autologous transplant

    Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.

    Biological: anti-thymocyte globulin
    Equine ATG dose is 15 mg/kg intravenously (IV) every 12 hours for 6 doses on days -6, - 5, and -4.
    Other Names:
  • ATGAM
  • ATG
  • Drug: cyclophosphamide
    Cyclophosphamide 50mg/kg x 1 to be administered IV over 2 hours with high volume fluid flush on day -6.
    Other Names:
  • Cytoxan
  • Drug: Fludarabine
    Fludarabine 40 mg/m2/day or 30 mg/m2/day intravenously (IV) as one hour infusion x 5 days, on day -6 to -2.
    Other Names:
  • Fludara
  • Drug: mycophenolate mofetil
    Mycophenolate mofetil (MMF) 3 gram/day for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours.
    Other Names:
  • MMF
  • Procedure: umbilical cord blood transplantation
    One or 2 UCB units may be infused to achieve the required cell dose.
    Other Names:
  • UCBT
  • Radiation: total body irradiation
    Administered Day -1, 200 cGy
    Other Names:
  • TBI
  • Drug: Sirolimus
    Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL. Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation.
    Other Names:
  • rapamycin
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Who Were Alive at 1 Year Post Transplant [1 Year]

      Overall Survival - Number of patients alive at 1 year post transplant

    2. Number of Participants Who Were Alive at 2 Years Post Transplant [2 Years]

      Overall Survival - Number of patients alive at 2 years post transplant

    Secondary Outcome Measures

    1. Number of Participants Who Were Dead at 6 Months After Study Completion [Month 6]

      Incidence of Non-relapse mortality - Number of Patients Dead at 6 Months after study completion

    2. Percentage of Donor Chimerism at 21 Days [21 days]

      Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.

    3. Percentage of Donor Chimerism at 100 Days [100 days]

      Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.

    4. Percentage of Donor Chimerism at 180 Days [180 Days]

      Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.

    5. Percentage of Donor Chimerism at 365 Days [365 days]

      Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.

    6. Number of Participants With Neutrophil Engraftment [Day 42]

      Time to 1st 3 consecutive days with absolute neutrophil count (ANC) > 5 x 10^8/L and percentage of patients with neutrophil recovery by day 42 (Cumulative incidence).

    7. Number of Participants With Platelet Engraftment [Day 180]

      Time to platelets > 20,000 (first of 3 consecutive days) with no platelet transfusions for seven days and percentage of patients with platelet engraftment >50,000 by day 100.

    8. Number of Participants With Acute Graft-versus-host Disease (GVHD) [Day 100]

      Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

    9. Number of Participants With Chronic Graft-Versus-Host Disease [1 Year]

      Determine the incidence of chronic GVHD at 1 year after transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

    10. Number of Participants Experiencing Progression-free Survival [1 Year]

      Incidence of Progression-free survival - Number of patients who were alive and did not have disease progression. Patients with leukemia and lymphoma involving the bone marrow (BM) and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

    11. Number of Participants Experiencing Progression-free Survival at 2 Years [2 Years]

      Incidence of Progression-free survival - Number of patients who were alive and did not have disease progression

    12. Number of Participants Experiencing Relapse (Incidence of Relapse) [Year 1]

      Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

    13. Number of Participants Experiencing Relapse (Incidence of Relapse) at 2 Years [2 years]

      Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Age, Graft Cell Dose and Graft HLA Criteria

    • Subjects must be <70 years old. Subjects ages ≥ 70 and ≤ 75 may be eligible if they have a Co-Morbidity Scoring (HCT-CI) score ≤ 2.

    • The UCB graft is matched at 4-6 HLA-A, B, DRB1 antigens with the recipient.

    • Patients co-enrolled in MT-2006-01 Phase I Study of Infusion of Umbilical Cord Blood Derived CD25+CD4+ T-Regulatory (Treg) Cells after Non-Myeloablative Cord\Blood Transplantation will receive grafts composed of 2 UCB units.

    Disease Criteria:
    • Acute Leukemias:

    • Acute myeloid leukemia: high risk complete remission 1 (CR1) (as evidenced by preceding myelodysplastic syndrome (MDS), high risk cytogenetics such as those associated with MDS or complex karyotype, > 2 cycles to obtain CR or erythroblastic and megakaryocytic); second or greater CR.

    • Acute lymphoblastic leukemia/lymphoma: high risk CR1 as evidenced by high risk cytogenetics (e.g. t(9;22), t(1;19),t(4;11), other myeloid/lymphoid or mixed lineage leukemia [MLL] rearrangements, hypodiploidy or Ikaros family zinc finger 1 [IKZF1]), > 1 cycle to obtain CR or evidence of minimal residual disease (MRD). Patients in second or greater CR are also eligible.

    • Burkitt's lymphoma in CR2 or subsequent CR

    • Natural Killer cell malignancies

    • Chronic myelogenous leukemia: all types except refractory blast crisis. Chronic phase patients must have failed or been intolerant to Gleevec

    • Myelodysplastic syndrome:

    • Large-cell lymphoma, Hodgkin lymphoma and multiple myeloma with chemotherapy sensitive disease that has failed or patients who are ineligible for an autologous transplant.

    • Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma, which have progressed within 12 months of achieving a partial or complete remission. Patients who had remissions lasting > 12 months, are eligible after at least two prior therapies. Patients with bulky disease should be considered for debulking chemotherapy before transplant. Patients with refractory disease are eligible, unless has bulky disease and an estimated tumor doubling time of less than one month.

    • Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are eligible after initial therapy if chemotherapy sensitive.

    • Refractory leukemia or MDS.

    • Bone marrow failure syndromes, except for Fanconi Anemia

    • Myeloproliferative syndromes Patients who have undergone an autologous transplant >12 months prior to allogeneic transplantation

    Adequate Organ Function and Performance Status

    Exclusion Criteria:
    • < 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor

    • Pregnancy or breastfeeding

    • Evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology

    • Current active serious infection

    • Unless in post-chemotherapy and radioimmunoconjugated antibody induced aplasia, when he/she would be eligible for Arm 3, patients with acute leukemia in morphologic relapse/ persistent disease defined as > 5% blasts in normocellular bone marrow OR any % blasts if blasts have unique morphologic markers (e.g. Auer rods) or associated cytogenetic markers that allows morphologic relapse to be distinguished are not eligible.

    • Chronic myelogenous leukemia (CML) in refractory blast crisis

    • Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.

    • Active central nervous system malignancy

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Masonic Cancer Center at University of MinnesotaMinneapolisMinnesotaUnited States55455

    Sponsors and Collaborators

    • Masonic Cancer Center, University of Minnesota

    Investigators

    • Principal Investigator: Claudio G. Brunstein, MD, PhD, Masonic Cancer Center, University of Minnesota

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Masonic Cancer Center, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT00305682
    Other Study ID Numbers:
    • 2005LS036
    • UMN-MT-2005-02
    • UMN-0507M70121
    First Posted:
    Mar 22, 2006
    Last Update Posted:
    Nov 19, 2020
    Last Verified:
    Oct 1, 2020

    Study Results

    Participant Flow

    Recruitment Details7 patients were excluded from receiving the treatment as they were not eligible. 4 patients were removed from the study because the participating site withdrew the participation from the study
    Pre-assignment Detail
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Period Title: Overall Study
    STARTED98717343935
    COMPLETED98717343935
    NOT COMPLETED000000

    Baseline Characteristics

    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous TransplantTotal
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Total of all reporting groups
    Overall Participants98717343935284
    Age (Count of Participants)
    <=18 years
    7
    7.1%
    3
    4.2%
    0
    0%
    0
    0%
    0
    0%
    1
    2.9%
    11
    3.9%
    Between 18 and 65 years
    79
    80.6%
    55
    77.5%
    6
    85.7%
    30
    88.2%
    29
    74.4%
    19
    54.3%
    218
    76.8%
    >=65 years
    12
    12.2%
    13
    18.3%
    1
    14.3%
    4
    11.8%
    10
    25.6%
    15
    42.9%
    55
    19.4%
    Sex: Female, Male (Count of Participants)
    Female
    37
    37.8%
    29
    40.8%
    5
    71.4%
    16
    47.1%
    14
    35.9%
    15
    42.9%
    116
    40.8%
    Male
    61
    62.2%
    42
    59.2%
    2
    28.6%
    18
    52.9%
    25
    64.1%
    20
    57.1%
    168
    59.2%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.4%
    Asian
    0
    0%
    2
    2.8%
    1
    14.3%
    1
    2.9%
    0
    0%
    2
    5.7%
    6
    2.1%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    0
    0%
    1
    2.9%
    2
    0.7%
    Black or African American
    6
    6.1%
    1
    1.4%
    0
    0%
    2
    5.9%
    0
    0%
    1
    2.9%
    10
    3.5%
    White
    82
    83.7%
    61
    85.9%
    5
    71.4%
    31
    91.2%
    39
    100%
    30
    85.7%
    248
    87.3%
    More than one race
    1
    1%
    1
    1.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    0.7%
    Unknown or Not Reported
    9
    9.2%
    4
    5.6%
    1
    14.3%
    0
    0%
    0
    0%
    1
    2.9%
    15
    5.3%
    Region of Enrollment (participants) [Number]
    United States
    98
    100%
    71
    100%
    7
    100%
    34
    100%
    39
    100%
    35
    100%
    284
    100%

    Outcome Measures

    1. Primary Outcome
    TitleNumber of Participants Who Were Alive at 1 Year Post Transplant
    DescriptionOverall Survival - Number of patients alive at 1 year post transplant
    Time Frame1 Year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Measure Participants98717343935
    Count of Participants [Participants]
    59
    60.2%
    40
    56.3%
    1
    14.3%
    26
    76.5%
    26
    66.7%
    25
    71.4%
    2. Primary Outcome
    TitleNumber of Participants Who Were Alive at 2 Years Post Transplant
    DescriptionOverall Survival - Number of patients alive at 2 years post transplant
    Time Frame2 Years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Measure Participants98717343935
    Count of Participants [Participants]
    50
    51%
    31
    43.7%
    1
    14.3%
    20
    58.8%
    21
    53.8%
    23
    65.7%
    3. Secondary Outcome
    TitleNumber of Participants Who Were Dead at 6 Months After Study Completion
    DescriptionIncidence of Non-relapse mortality - Number of Patients Dead at 6 Months after study completion
    Time FrameMonth 6

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Measure Participants98717343935
    Count of Participants [Participants]
    10
    10.2%
    20
    28.2%
    2
    28.6%
    5
    14.7%
    3
    7.7%
    6
    17.1%
    4. Secondary Outcome
    TitlePercentage of Donor Chimerism at 21 Days
    DescriptionChimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
    Time Frame21 days

    Outcome Measure Data

    Analysis Population Description
    A total of 43 participants were not evaluable
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Measure Participants86616253528
    Mean (Standard Deviation) [percentage of donor cells]
    77
    (25)
    73
    (32)
    57
    (29)
    77
    (21)
    69
    (32)
    68
    (33)
    5. Secondary Outcome
    TitlePercentage of Donor Chimerism at 100 Days
    DescriptionChimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
    Time Frame100 days

    Outcome Measure Data

    Analysis Population Description
    A total of 85 participants were not evaluable.
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Measure Participants64502302726
    Mean (Standard Deviation) [percentage of donor cells]
    94
    (18)
    94
    (21)
    100
    (0)
    93
    (23)
    85
    (31)
    86
    (32)
    6. Secondary Outcome
    TitlePercentage of Donor Chimerism at 180 Days
    DescriptionChimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
    Time Frame180 Days

    Outcome Measure Data

    Analysis Population Description
    A total of 134 participants were not evaluable
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Measure Participants49322222223
    Mean (Standard Deviation) [percentage of donor cells]
    96
    (18)
    98
    (6)
    88
    (17)
    94
    (16)
    91
    (26)
    98
    (10)
    7. Secondary Outcome
    TitlePercentage of Donor Chimerism at 365 Days
    DescriptionChimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
    Time Frame365 days

    Outcome Measure Data

    Analysis Population Description
    A total of 160 participants were not evaluable
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Measure Participants42270191620
    Mean (Standard Deviation) [percentage of donor cells]
    99
    (2)
    98
    (12)
    99
    (6)
    87
    (34)
    100
    (0)
    8. Secondary Outcome
    TitleNumber of Participants With Neutrophil Engraftment
    DescriptionTime to 1st 3 consecutive days with absolute neutrophil count (ANC) > 5 x 10^8/L and percentage of patients with neutrophil recovery by day 42 (Cumulative incidence).
    Time FrameDay 42

    Outcome Measure Data

    Analysis Population Description
    7 participants were not evaluable
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Measure Participants97677343834
    Count of Participants [Participants]
    93
    94.9%
    65
    91.5%
    6
    85.7%
    32
    94.1%
    32
    82.1%
    29
    82.9%
    9. Secondary Outcome
    TitleNumber of Participants With Platelet Engraftment
    DescriptionTime to platelets > 20,000 (first of 3 consecutive days) with no platelet transfusions for seven days and percentage of patients with platelet engraftment >50,000 by day 100.
    Time FrameDay 180

    Outcome Measure Data

    Analysis Population Description
    13 participants were not evaluable
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Measure Participants96637343734
    Count of Participants [Participants]
    75
    76.5%
    47
    66.2%
    3
    42.9%
    28
    82.4%
    34
    87.2%
    25
    71.4%
    10. Secondary Outcome
    TitleNumber of Participants With Acute Graft-versus-host Disease (GVHD)
    DescriptionDetermine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
    Time FrameDay 100

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Measure Participants98717343935
    Count of Participants [Participants]
    45
    45.9%
    24
    33.8%
    1
    14.3%
    12
    35.3%
    13
    33.3%
    13
    37.1%
    11. Secondary Outcome
    TitleNumber of Participants With Chronic Graft-Versus-Host Disease
    DescriptionDetermine the incidence of chronic GVHD at 1 year after transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
    Time Frame1 Year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Measure Participants98717343935
    Count of Participants [Participants]
    18
    18.4%
    20
    28.2%
    0
    0%
    3
    8.8%
    3
    7.7%
    3
    8.6%
    12. Secondary Outcome
    TitleNumber of Participants Experiencing Progression-free Survival
    DescriptionIncidence of Progression-free survival - Number of patients who were alive and did not have disease progression. Patients with leukemia and lymphoma involving the bone marrow (BM) and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
    Time Frame1 Year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Measure Participants98717343935
    Count of Participants [Participants]
    43
    43.9%
    32
    45.1%
    1
    14.3%
    21
    61.8%
    16
    41%
    24
    68.6%
    13. Secondary Outcome
    TitleNumber of Participants Experiencing Progression-free Survival at 2 Years
    DescriptionIncidence of Progression-free survival - Number of patients who were alive and did not have disease progression
    Time Frame2 Years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Measure Participants98717343935
    Count of Participants [Participants]
    36
    36.7%
    25
    35.2%
    1
    14.3%
    17
    50%
    16
    41%
    20
    57.1%
    14. Secondary Outcome
    TitleNumber of Participants Experiencing Relapse (Incidence of Relapse)
    DescriptionPatients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
    Time FrameYear 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Measure Participants98717343935
    Count of Participants [Participants]
    43
    43.9%
    14
    19.7%
    4
    57.1%
    7
    20.6%
    20
    51.3%
    2
    5.7%
    15. Secondary Outcome
    TitleNumber of Participants Experiencing Relapse (Incidence of Relapse) at 2 Years
    DescriptionPatients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
    Time Frame2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    Measure Participants98717343935
    Count of Participants [Participants]
    49
    50%
    19
    26.8%
    4
    57.1%
    11
    32.4%
    20
    51.3%
    4
    11.4%

    Adverse Events

    Time Frame2 years
    Adverse Event Reporting Description
    Arm/Group TitleArm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Arm/Group Descriptionhematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
    All Cause Mortality
    Arm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total48/98 (49%) 40/71 (56.3%) 6/7 (85.7%) 14/34 (41.2%) 18/39 (46.2%) 12/35 (34.3%)
    Serious Adverse Events
    Arm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total53/98 (54.1%) 48/71 (67.6%) 3/7 (42.9%) 11/34 (32.4%) 2/39 (5.1%) 4/35 (11.4%)
    Blood and lymphatic system disorders
    Blood/Bone Marrow,other - relapse disease0/98 (0%) 00/71 (0%) 00/7 (0%) 02/34 (5.9%) 21/39 (2.6%) 12/35 (5.7%) 2
    Bone marrow cellularity - aplasia0/98 (0%) 00/71 (0%) 00/7 (0%) 01/34 (2.9%) 10/39 (0%) 00/35 (0%) 0
    CNS hemorrhage/bleeding1/98 (1%) 10/71 (0%) 00/7 (0%) 00/34 (0%) 01/39 (2.6%) 10/35 (0%) 0
    Cardiac disorders
    Cardiovascular, other disorder - substernal chest discomfort1/98 (1%) 10/71 (0%) 00/7 (0%) 01/34 (2.9%) 10/39 (0%) 00/35 (0%) 0
    Immune system disorders
    Graft versus host disease4/98 (4.1%) 45/71 (7%) 50/7 (0%) 01/34 (2.9%) 10/39 (0%) 00/35 (0%) 0
    Infections and infestations
    Catheter related infection0/98 (0%) 00/71 (0%) 00/7 (0%) 00/34 (0%) 00/39 (0%) 01/35 (2.9%) 1
    Infection without neutropenia1/98 (1%) 11/71 (1.4%) 10/7 (0%) 00/34 (0%) 00/39 (0%) 00/35 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Primary Graft Failure0/98 (0%) 01/71 (1.4%) 10/7 (0%) 00/34 (0%) 00/39 (0%) 01/35 (2.9%) 1
    Death19/98 (19.4%) 1924/71 (33.8%) 242/7 (28.6%) 21/34 (2.9%) 10/39 (0%) 00/35 (0%) 0
    Progressive Disease8/98 (8.2%) 82/71 (2.8%) 20/7 (0%) 00/34 (0%) 00/39 (0%) 00/35 (0%) 0
    Relapse19/98 (19.4%) 1911/71 (15.5%) 111/7 (14.3%) 13/34 (8.8%) 30/39 (0%) 00/35 (0%) 0
    Nervous system disorders
    Leukoencephalopathy associated with radiological findings0/98 (0%) 01/71 (1.4%) 10/7 (0%) 00/34 (0%) 00/39 (0%) 00/35 (0%) 0
    Guillamme Barre syndrome0/98 (0%) 00/71 (0%) 00/7 (0%) 01/34 (2.9%) 10/39 (0%) 00/35 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Adult respiratory distress syndrome (ARDS)0/98 (0%) 01/71 (1.4%) 10/7 (0%) 00/34 (0%) 00/39 (0%) 00/35 (0%) 0
    Idiopathic pneumonia0/98 (0%) 02/71 (2.8%) 20/7 (0%) 00/34 (0%) 00/39 (0%) 00/35 (0%) 0
    Skin and subcutaneous tissue disorders
    Dermatology/Skin disorder0/98 (0%) 00/71 (0%) 00/7 (0%) 01/34 (2.9%) 10/39 (0%) 00/35 (0%) 0
    Other (Not Including Serious) Adverse Events
    Arm 1-Previous Autologous TransplantArm 2 - No Prior Autologous TransplantArm 3 - Refractory Leukemia/LymphomaArm 4: MT2006-01 Coenrolling PatientsArm 5 - Previous Autologous TransplantArm 6 - No Prior Autologous Transplant
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total76/98 (77.6%) 54/71 (76.1%) 5/7 (71.4%) 20/34 (58.8%) 33/39 (84.6%) 35/35 (100%)
    Blood and lymphatic system disorders
    Anemia1/98 (1%) 10/71 (0%) 00/7 (0%) 02/34 (5.9%) 20/39 (0%) 00/35 (0%) 0
    Bleeding8/98 (8.2%) 96/71 (8.5%) 61/7 (14.3%) 11/34 (2.9%) 14/39 (10.3%) 72/35 (5.7%) 3
    Deep vein thrombosis (DVT)4/98 (4.1%) 42/71 (2.8%) 20/7 (0%) 00/34 (0%) 03/39 (7.7%) 30/35 (0%) 0
    Hemorrhage3/98 (3.1%) 32/71 (2.8%) 20/7 (0%) 01/34 (2.9%) 12/39 (5.1%) 22/35 (5.7%) 2
    thrombocytopenia0/98 (0%) 00/71 (0%) 01/7 (14.3%) 11/34 (2.9%) 11/39 (2.6%) 11/35 (2.9%) 1
    Thrombotic thrombocytopenic purpura1/98 (1%) 11/71 (1.4%) 11/7 (14.3%) 11/34 (2.9%) 10/39 (0%) 00/35 (0%) 0
    Cardiac disorders
    Heart disorder4/98 (4.1%) 76/71 (8.5%) 101/7 (14.3%) 13/34 (8.8%) 46/39 (15.4%) 107/35 (20%) 10
    Heart failure1/98 (1%) 10/71 (0%) 01/7 (14.3%) 10/34 (0%) 00/39 (0%) 00/35 (0%) 0
    pericardial effusion10/98 (10.2%) 1114/71 (19.7%) 171/7 (14.3%) 14/34 (11.8%) 45/39 (12.8%) 62/35 (5.7%) 2
    Supraventricular tachycardia (SVT)1/98 (1%) 10/71 (0%) 01/7 (14.3%) 10/34 (0%) 00/39 (0%) 01/35 (2.9%) 1
    Gastrointestinal disorders
    GI disorder5/98 (5.1%) 63/71 (4.2%) 40/7 (0%) 02/34 (5.9%) 33/39 (7.7%) 33/35 (8.6%) 3
    General disorders
    Engraftment syndrome1/98 (1%) 12/71 (2.8%) 20/7 (0%) 02/34 (5.9%) 27/39 (17.9%) 73/35 (8.6%) 3
    Infections and infestations
    Cytomegaloviral infection13/98 (13.3%) 145/71 (7%) 61/7 (14.3%) 22/34 (5.9%) 21/39 (2.6%) 16/35 (17.1%) 6
    Infection32/98 (32.7%) 11418/71 (25.4%) 514/7 (57.1%) 2311/34 (32.4%) 2733/39 (84.6%) 10133/35 (94.3%) 122
    mastoiditis0/98 (0%) 01/71 (1.4%) 21/7 (14.3%) 11/34 (2.9%) 10/39 (0%) 01/35 (2.9%) 1
    Metabolism and nutrition disorders
    hyperglycemia4/98 (4.1%) 43/71 (4.2%) 31/7 (14.3%) 13/34 (8.8%) 39/39 (23.1%) 910/35 (28.6%) 10
    Musculoskeletal and connective tissue disorders
    Myopathy2/98 (2%) 20/71 (0%) 00/7 (0%) 00/34 (0%) 00/39 (0%) 02/35 (5.7%) 2
    Nervous system disorders
    Encephalopathy1/98 (1%) 11/71 (1.4%) 10/7 (0%) 01/34 (2.9%) 11/39 (2.6%) 12/35 (5.7%) 2
    Neuropathy6/98 (6.1%) 62/71 (2.8%) 20/7 (0%) 03/34 (8.8%) 40/39 (0%) 03/35 (8.6%) 3
    neurotoxicity2/98 (2%) 311/71 (15.5%) 142/7 (28.6%) 41/34 (2.9%) 12/39 (5.1%) 33/35 (8.6%) 4
    Seizure1/98 (1%) 50/71 (0%) 01/7 (14.3%) 10/34 (0%) 01/39 (2.6%) 12/35 (5.7%) 2
    Renal and urinary disorders
    Acute kidney injury3/98 (3.1%) 33/71 (4.2%) 30/7 (0%) 02/34 (5.9%) 31/39 (2.6%) 14/35 (11.4%) 5
    Dialysis4/98 (4.1%) 48/71 (11.3%) 90/7 (0%) 02/34 (5.9%) 20/39 (0%) 03/35 (8.6%) 3
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome8/98 (8.2%) 165/71 (7%) 51/7 (14.3%) 11/34 (2.9%) 11/39 (2.6%) 11/35 (2.9%) 1
    Intubation12/98 (12.2%) 2015/71 (21.1%) 202/7 (28.6%) 55/34 (14.7%) 72/39 (5.1%) 26/35 (17.1%) 10
    Pneumonia39/98 (39.8%) 8637/71 (52.1%) 814/7 (57.1%) 1513/34 (38.2%) 2818/39 (46.2%) 3720/35 (57.1%) 60
    pulmonary hemorrhage3/98 (3.1%) 310/71 (14.1%) 113/7 (42.9%) 31/34 (2.9%) 11/39 (2.6%) 14/35 (11.4%) 5
    Skin and subcutaneous tissue disorders
    Skin rashes due to drug toxicity0/98 (0%) 00/71 (0%) 00/7 (0%) 01/34 (2.9%) 43/39 (7.7%) 31/35 (2.9%) 1
    Vascular disorders
    Hypertension4/98 (4.1%) 42/71 (2.8%) 21/7 (14.3%) 12/34 (5.9%) 26/39 (15.4%) 65/35 (14.3%) 5

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    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.

    Results Point of Contact

    Name/TitleDr.Claudio G. Brunstein MD, PhD
    OrganizationMasonic Cancer Center, University of Minnesota
    Phone612-625-3918
    Emailbruns072@umn.edu
    Responsible Party:
    Masonic Cancer Center, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT00305682
    Other Study ID Numbers:
    • 2005LS036
    • UMN-MT-2005-02
    • UMN-0507M70121
    First Posted:
    Mar 22, 2006
    Last Update Posted:
    Nov 19, 2020
    Last Verified:
    Oct 1, 2020