Stem Cell Transplant for Hematological Malignancy

Sponsor
Masonic Cancer Center, University of Minnesota (Other)
Overall Status
Terminated
CT.gov ID
NCT00176930
Collaborator
(none)
330
Enrollment
1
Location
8
Arms
218
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to develop a standard of care treatment using allogeneic stem cells for patients with cancers of the blood.

The protocol was revised to reflect that this study is considered "treatment guidelines", rather than a research study.

Condition or DiseaseIntervention/TreatmentPhase
N/A

Detailed Description

Preparative regimen using total body irradiation (TBI) and cyclophosphamide:
  1. on day -6 and -5: cyclophosphamide is given,

  2. on day -4, -3, -2, and -1: TBI is given,

  3. on day 0: stem cell or bone marrow is infused.

Alternate preparative therapy for patients not able to receive TBI

The chemotherapy (cyclophosphamide and busulfan) is given with the intent of destroying the bone marrow, eliminating any cancerous and preparing for the transplant of the donor's blood stem cells by suppressing the immune system.

  1. Ten days before the transplant (Day 10), subjects will be admitted to the bone marrow transplant unit and placed in isolation to reduce exposure to infections. Isolation will be continued until adequate numbers of cells are present in the blood to fight infection.
  1. On day -9, -8, -7, -6 busulfan is given.

  2. On day -5, -4, -3, -2 cyclophosphamide is given.

  3. On day -1 no therapy is given (day of rest).

  4. On day 0 the donor stem cells are given intravenously. Additional cells may be given on day +1 or 2 as needed.

Transplant:

Subjects will be admitted to the bone marrow transplant unit and put in isolation to reduce exposure to infectious agents. During this time, they will receive the preparative treatment outlined above. Once they have received the preparative regimen, stem cells will be obtained from the donor and given intravenously.

The new stem cells will replace the bone marrow that was damaged by the treatment for the cancer.

Isolation will be continued until adequate numbers of cells are present in the blood to fight infection. Subjects will then be transferred from the bone marrow transplant unit and discharged from the hospital when medically ready. Subjects will be expected to return for follow-up to the bone marrow transplant clinic at specific dates as determined by their physician.

Study Design

Study Type:
Interventional
Actual Enrollment :
330 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Allogeneic Transplant for Hematological Malignancy
Actual Study Start Date :
Oct 1, 2001
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

ArmIntervention/Treatment
Experimental: PBSC: No TBI

Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant

Biological: Stem Cell Transplant
Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. (Allowable sources of stem cells = related or unrelated bone marrow or peripheral blood, for Busulfan/cyclophosphamide/ATG preparative chemo only, umbilical cord blood is also permitted.)
Other Names:
  • Bone Marrow Transplant.
  • Drug: Cyclophosphamide
    60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
    Other Names:
  • Cytoxan
  • Drug: Busulfan
    When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.
    Other Names:
  • Busulfex
  • Myleran
  • Experimental: Marrow : No TBI

    Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant

    Biological: Stem Cell Transplant
    Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. (Allowable sources of stem cells = related or unrelated bone marrow or peripheral blood, for Busulfan/cyclophosphamide/ATG preparative chemo only, umbilical cord blood is also permitted.)
    Other Names:
  • Bone Marrow Transplant.
  • Drug: Cyclophosphamide
    60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
    Other Names:
  • Cytoxan
  • Drug: Busulfan
    When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.
    Other Names:
  • Busulfex
  • Myleran
  • Experimental: UCB : No TBI

    Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant

    Biological: Stem Cell Transplant
    Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. (Allowable sources of stem cells = related or unrelated bone marrow or peripheral blood, for Busulfan/cyclophosphamide/ATG preparative chemo only, umbilical cord blood is also permitted.)
    Other Names:
  • Bone Marrow Transplant.
  • Drug: Cyclophosphamide
    60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
    Other Names:
  • Cytoxan
  • Drug: Busulfan
    When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.
    Other Names:
  • Busulfex
  • Myleran
  • Experimental: UCB : No TBI/Bu/Cy/ATG

    Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen

    Biological: Stem Cell Transplant
    Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. (Allowable sources of stem cells = related or unrelated bone marrow or peripheral blood, for Busulfan/cyclophosphamide/ATG preparative chemo only, umbilical cord blood is also permitted.)
    Other Names:
  • Bone Marrow Transplant.
  • Drug: Cyclophosphamide
    60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
    Other Names:
  • Cytoxan
  • Drug: Busulfan
    When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.
    Other Names:
  • Busulfex
  • Myleran
  • Drug: Equine ATG (ATGAM)
    UCB recipients who have not had chemotherapy in the preceding 3 months will also receive Equine ATG (ATGAM) 15 mg/kg IV will be administered every 12 hours for 6 doses beginning on day -3 per institutional guidelines

    Experimental: PBSC

    Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant

    Biological: Stem Cell Transplant
    Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. (Allowable sources of stem cells = related or unrelated bone marrow or peripheral blood, for Busulfan/cyclophosphamide/ATG preparative chemo only, umbilical cord blood is also permitted.)
    Other Names:
  • Bone Marrow Transplant.
  • Drug: Cyclophosphamide
    60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
    Other Names:
  • Cytoxan
  • Radiation: Total Body Irradiation
    On Day -4, -3, -2, -1 total body irradiation is given twice daily.
    Other Names:
  • Radiation therapy
  • Experimental: Marrow

    Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant

    Biological: Stem Cell Transplant
    Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. (Allowable sources of stem cells = related or unrelated bone marrow or peripheral blood, for Busulfan/cyclophosphamide/ATG preparative chemo only, umbilical cord blood is also permitted.)
    Other Names:
  • Bone Marrow Transplant.
  • Drug: Cyclophosphamide
    60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
    Other Names:
  • Cytoxan
  • Radiation: Total Body Irradiation
    On Day -4, -3, -2, -1 total body irradiation is given twice daily.
    Other Names:
  • Radiation therapy
  • Experimental: UCB

    Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant

    Biological: Stem Cell Transplant
    Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. (Allowable sources of stem cells = related or unrelated bone marrow or peripheral blood, for Busulfan/cyclophosphamide/ATG preparative chemo only, umbilical cord blood is also permitted.)
    Other Names:
  • Bone Marrow Transplant.
  • Drug: Cyclophosphamide
    60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
    Other Names:
  • Cytoxan
  • Radiation: Total Body Irradiation
    On Day -4, -3, -2, -1 total body irradiation is given twice daily.
    Other Names:
  • Radiation therapy
  • Experimental: Co-Enroll From MT0403

    Patients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)

    Biological: Stem Cell Transplant
    Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. (Allowable sources of stem cells = related or unrelated bone marrow or peripheral blood, for Busulfan/cyclophosphamide/ATG preparative chemo only, umbilical cord blood is also permitted.)
    Other Names:
  • Bone Marrow Transplant.
  • Drug: Cyclophosphamide
    60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
    Other Names:
  • Cytoxan
  • Radiation: Total Body Irradiation
    On Day -4, -3, -2, -1 total body irradiation is given twice daily.
    Other Names:
  • Radiation therapy
  • Biological: CD4+/CD25+ cells
    On days -2, patients will receive CD4+/CD25+ cells intravenously.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant [2 years]

      Disease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working.

    2. Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant [5 years]

      Disease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working.

    Secondary Outcome Measures

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

      Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm^3 (0.5 x 10^9/L) or greater.

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

      Acute Graft-Versus-Host Disease (aGVHD) is a severe short-term complication created by infusion of donor cells into a foreign host. Determine the incidence of grade II-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.

    3. Number of Participants With Chronic Graft-Versus-Host Disease [1 year]

      Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Determine the incidence of chronic GVHD 1 year post 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.

    4. Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant [2 years]

      Defined as the return of disease after its apparent recovery/cessation. 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.

    5. Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant [5 years]

      Defined as the return of disease after its apparent recovery/cessation. 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.

    6. Number of Participants Who Were Alive at 2 Year Post Transplant [2 years]

      The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer.

    7. Number of Participants Who Were Alive at 5 Year Post Transplant [5 years]

      The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer.

    8. Number of Participants Experiencing Engraftment Failure [Day 42]

      Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Donor will be <75 years of age and in good health.

    • Recipients will be < or = 55 years, will have normal organ function (excluding bone marrow) and will have a Karnofsky activity assessment > or = 90%.

    • Recipients with related or unrelated donor matched at the HLA A, B, DRB1 loci, or mismatched related or unrelated (if < 35 years old) at a single HLA A, B, DRB1 locus.

    • Recipients will be eligible in one of the following disease categories

    • Chronic myelogenous leukemia in accelerated phase or in post blast crisis second or greater chronic phase; or in chronic phase but intolerant of or resistant to tyrosine kinase inhibitors.

    • Acute myelocytic leukemia in first or greater remission, or first, second or third relapse.

    • Acute lymphocytic leukemia in the 2nd or greater bone marrow remission.

    • High risk children will be transplanted in first remission if they meet criteria

    • Myelodysplastic syndrome.

    • Myeloproliferative Diseases - (i.e. myelofibrosis, chronic myelomonocytic leukemia (CMML))

    • Juvenile myelomonocytic leukemia

    • Chronic lymphocytic leukemia

    • Advanced non-Hodgkin's (NHL).

    • Advanced Hodgkin's disease beyond PR2 (> CR3, > PR3).

    • Multiple Myeloma after initial therapy.

    • Donors and recipients signed informed consent

    Exclusion Criteria

    donors and recipients should meet the following test criteria.

    • required for donors:

    • anti-HIV, Hepatitis B, surface antigen, anti-HCV, CMV, HSV, EBV serologies, pre-priming.

    • CBC, platelet count each day of apheresis, day 0 (or 1 or 2 as needed)

    • required for recipients:

    • anti-HIV, Hepatitis B, surface antigen, anti-HCV, CMV, HSV, EBV serologies, pre-transplant.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Masonic Cancer Center, University of MinnesotaMinneapolisMinnesotaUnited States55455

    Sponsors and Collaborators

    • Masonic Cancer Center, University of Minnesota

    Investigators

    • Principal Investigator: Daniel Weisdorf, MD, Masonic Cancer Center, University of Minnesota

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Masonic Cancer Center, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT00176930
    Other Study ID Numbers:
    • 2001LS049
    • MT2001-02
    • 0107M05202
    • NCT00393133
    First Posted:
    Sep 15, 2005
    Last Update Posted:
    Jan 22, 2021
    Last Verified:
    Dec 1, 2020

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment DetailOne patient withdrew consent.
    Arm/Group TitlePBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403
    Arm/Group DescriptionPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Busulfan: When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Busulfan: When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Busulfan: When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Busulfan: When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours. Equine ATG (ATGAM): UCB recipients who have not had chemotherapy in the preceding 3 months will also receive Equine ATG (ATGAM) 15 mg/kg IV will be administered every 12 hours for 6 doses beginning on day -3 per institutional guidelinesPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Total Body Irradiation: On Day -4, -3, -2, -1 total body irradiation is given twice daily.Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Total Body Irradiation: On Day -4, -3, -2, -1 total body irradiation is given twice daily.Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Total Body Irradiation: On Day -4, -3, -2, -1 total body irradiation is given twice daily.Patients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062) Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Total Body Irradiation: On Day -4, -3, -2, -1 total body irradiation is given twice daily. CD4+/CD25+ cells: On days -2, patients will receive CD4+/CD25+ cells intravenously.
    Period Title: Overall Study
    STARTED1213112138522
    COMPLETED1213112138522
    NOT COMPLETED00000000

    Baseline Characteristics

    Arm/Group TitlePBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403Total
    Arm/Group DescriptionPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimenPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)Total of all reporting groups
    Overall Participants1213112138522329
    Age (Count of Participants)
    <=18 years
    0
    0%
    12
    92.3%
    0
    0%
    0
    0%
    9
    4.2%
    51
    60%
    2
    100%
    2
    100%
    76
    23.1%
    Between 18 and 65 years
    12
    100%
    1
    7.7%
    1
    100%
    1
    100%
    204
    95.8%
    34
    40%
    0
    0%
    0
    0%
    253
    76.9%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    10
    83.3%
    4
    30.8%
    0
    0%
    1
    100%
    78
    36.6%
    35
    41.2%
    1
    50%
    1
    50%
    130
    39.5%
    Male
    2
    16.7%
    9
    69.2%
    1
    100%
    0
    0%
    135
    63.4%
    50
    58.8%
    1
    50%
    1
    50%
    199
    60.5%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.5%
    4
    4.7%
    0
    0%
    0
    0%
    5
    1.5%
    Not Hispanic or Latino
    5
    41.7%
    11
    84.6%
    1
    100%
    1
    100%
    82
    38.5%
    41
    48.2%
    2
    100%
    2
    100%
    145
    44.1%
    Unknown or Not Reported
    7
    58.3%
    2
    15.4%
    0
    0%
    0
    0%
    130
    61%
    40
    47.1%
    0
    0%
    0
    0%
    179
    54.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    4
    1.9%
    3
    3.5%
    0
    0%
    0
    0%
    7
    2.1%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    6
    2.8%
    4
    4.7%
    0
    0%
    0
    0%
    10
    3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    1.2%
    0
    0%
    0
    0%
    1
    0.3%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    5
    2.3%
    3
    3.5%
    0
    0%
    0
    0%
    8
    2.4%
    White
    11
    91.7%
    13
    100%
    1
    100%
    1
    100%
    178
    83.6%
    64
    75.3%
    2
    100%
    2
    100%
    272
    82.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    1
    8.3%
    0
    0%
    0
    0%
    0
    0%
    20
    9.4%
    10
    11.8%
    0
    0%
    0
    0%
    31
    9.4%
    Region of Enrollment (participants) [Number]
    United States
    12
    100%
    13
    100%
    1
    100%
    1
    100%
    213
    100%
    85
    100%
    2
    100%
    2
    100%
    329
    100%

    Outcome Measures

    1. Primary Outcome
    TitleNumber of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant
    DescriptionDisease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working.
    Time Frame2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403
    Arm/Group DescriptionPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimenPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
    Measure Participants1213112138522
    Count of Participants [Participants]
    4
    33.3%
    9
    69.2%
    0
    0%
    0
    0%
    100
    46.9%
    52
    61.2%
    2
    100%
    2
    100%
    2. Primary Outcome
    TitleNumber of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant
    DescriptionDisease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working.
    Time Frame5 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403
    Arm/Group DescriptionPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimenPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
    Measure Participants1213112138522
    Count of Participants [Participants]
    3
    25%
    9
    69.2%
    0
    0%
    0
    0%
    85
    39.9%
    48
    56.5%
    2
    100%
    2
    100%
    3. Secondary Outcome
    TitleNumber of Participants With Neutrophil Engraftment
    DescriptionNeutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm^3 (0.5 x 10^9/L) or greater.
    Time FrameDay 42

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403
    Arm/Group DescriptionPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimenPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
    Measure Participants1213112138522
    Count of Participants [Participants]
    11
    91.7%
    13
    100%
    0
    0%
    1
    100%
    206
    96.7%
    83
    97.6%
    2
    100%
    2
    100%
    4. Secondary Outcome
    TitleNumber of Participants With Acute Graft-versus-host Disease (GVHD)
    DescriptionAcute Graft-Versus-Host Disease (aGVHD) is a severe short-term complication created by infusion of donor cells into a foreign host. Determine the incidence of grade II-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 TitlePBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403
    Arm/Group DescriptionPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimenPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
    Measure Participants1213112138522
    Count of Participants [Participants]
    6
    50%
    2
    15.4%
    1
    100%
    0
    0%
    89
    41.8%
    23
    27.1%
    0
    0%
    0
    0%
    5. Secondary Outcome
    TitleNumber of Participants With Chronic Graft-Versus-Host Disease
    DescriptionChronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Determine the incidence of chronic GVHD 1 year post 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 TitlePBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403
    Arm/Group DescriptionPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimenPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
    Measure Participants1213112138522
    Count of Participants [Participants]
    4
    33.3%
    2
    15.4%
    0
    0%
    0
    0%
    87
    40.8%
    14
    16.5%
    0
    0%
    1
    50%
    6. Secondary Outcome
    TitleNumber of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant
    DescriptionDefined as the return of disease after its apparent recovery/cessation. 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.
    Time Frame2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403
    Arm/Group DescriptionPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimenPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
    Measure Participants1213112138522
    Count of Participants [Participants]
    3
    25%
    4
    30.8%
    0
    0%
    0
    0%
    63
    29.6%
    17
    20%
    0
    0%
    0
    0%
    7. Secondary Outcome
    TitleNumber of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant
    DescriptionDefined as the return of disease after its apparent recovery/cessation. 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.
    Time Frame5 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403
    Arm/Group DescriptionPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimenPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
    Measure Participants1213112138522
    Count of Participants [Participants]
    4
    33.3%
    4
    30.8%
    0
    0%
    0
    0%
    69
    32.4%
    20
    23.5%
    0
    0%
    0
    0%
    8. Secondary Outcome
    TitleNumber of Participants Who Were Alive at 2 Year Post Transplant
    DescriptionThe percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer.
    Time Frame2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403
    Arm/Group DescriptionPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimenPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
    Measure Participants1213112138522
    Count of Participants [Participants]
    5
    41.7%
    11
    84.6%
    0
    0%
    0
    0%
    122
    57.3%
    59
    69.4%
    2
    100%
    2
    100%
    9. Secondary Outcome
    TitleNumber of Participants Who Were Alive at 5 Year Post Transplant
    DescriptionThe percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer.
    Time Frame5 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403
    Arm/Group DescriptionPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimenPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
    Measure Participants1213112138522
    Count of Participants [Participants]
    3
    25%
    9
    69.2%
    0
    0%
    0
    0%
    100
    46.9%
    54
    63.5%
    2
    100%
    2
    100%
    10. Secondary Outcome
    TitleNumber of Participants Experiencing Engraftment Failure
    DescriptionGraft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
    Time FrameDay 42

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403
    Arm/Group DescriptionPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimenPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
    Measure Participants1213112138522
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.5%
    0
    0%
    0
    0%
    0
    0%

    Adverse Events

    Time Frame5 years
    Adverse Event Reporting Description
    Arm/Group TitlePBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403
    Arm/Group DescriptionPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplantPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimenPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplantPatients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
    All Cause Mortality
    PBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total9/12 (75%) 4/13 (30.8%) 1/1 (100%) 1/1 (100%) 113/213 (53.1%) 31/85 (36.5%) 0/2 (0%) 0/2 (0%)
    Serious Adverse Events
    PBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total3/12 (25%) 0/13 (0%) 0/1 (0%) 0/1 (0%) 32/213 (15%) 10/85 (11.8%) 0/2 (0%) 0/2 (0%)
    Blood and lymphatic system disorders
    Hemorrhage0/12 (0%) 00/13 (0%) 00/1 (0%) 00/1 (0%) 01/213 (0.5%) 10/85 (0%) 00/2 (0%) 00/2 (0%) 0
    General disorders
    Death due to accident0/12 (0%) 00/13 (0%) 00/1 (0%) 00/1 (0%) 01/213 (0.5%) 10/85 (0%) 00/2 (0%) 00/2 (0%) 0
    Immune system disorders
    Graft versus host disease1/12 (8.3%) 10/13 (0%) 00/1 (0%) 00/1 (0%) 02/213 (0.9%) 20/85 (0%) 00/2 (0%) 00/2 (0%) 0
    Syndromes0/12 (0%) 00/13 (0%) 00/1 (0%) 00/1 (0%) 01/213 (0.5%) 10/85 (0%) 00/2 (0%) 00/2 (0%) 0
    Infections and infestations
    Death0/12 (0%) 00/13 (0%) 00/1 (0%) 00/1 (0%) 04/213 (1.9%) 40/85 (0%) 00/2 (0%) 00/2 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Primary Graft Failure1/12 (8.3%) 10/13 (0%) 00/1 (0%) 00/1 (0%) 00/213 (0%) 01/85 (1.2%) 10/2 (0%) 00/2 (0%) 0
    Death1/12 (8.3%) 10/13 (0%) 00/1 (0%) 00/1 (0%) 020/213 (9.4%) 208/85 (9.4%) 80/2 (0%) 00/2 (0%) 0
    Relapse1/12 (8.3%) 10/13 (0%) 00/1 (0%) 00/1 (0%) 08/213 (3.8%) 83/85 (3.5%) 30/2 (0%) 00/2 (0%) 0
    Other (Not Including Serious) Adverse Events
    PBSC: No TBIMarrow : No TBIUCB : No TBIUCB : No TBI/Bu/Cy/ATGPBSCMarrowUmbilical Cord BloodCo-Enroll From MT0403
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total12/12 (100%) 10/13 (76.9%) 1/1 (100%) 1/1 (100%) 183/213 (85.9%) 71/85 (83.5%) 2/2 (100%) 2/2 (100%)
    Cardiac disorders
    Pericardial effusion1/12 (8.3%) 15/13 (38.5%) 50/1 (0%) 01/1 (100%) 112/213 (5.6%) 1213/85 (15.3%) 130/2 (0%) 01/2 (50%) 2
    Cardiac disorder1/12 (8.3%) 11/13 (7.7%) 11/1 (100%) 10/1 (0%) 08/213 (3.8%) 86/85 (7.1%) 70/2 (0%) 01/2 (50%) 1
    Gastrointestinal disorders
    GI Bleeding3/12 (25%) 40/13 (0%) 00/1 (0%) 00/1 (0%) 024/213 (11.3%) 266/85 (7.1%) 70/2 (0%) 00/2 (0%) 0
    Mucositis2/12 (16.7%) 20/13 (0%) 00/1 (0%) 00/1 (0%) 013/213 (6.1%) 132/85 (2.4%) 20/2 (0%) 00/2 (0%) 0
    Hepatobiliary disorders
    Elevated Liver Function Tests2/12 (16.7%) 21/13 (7.7%) 10/1 (0%) 00/1 (0%) 025/213 (11.7%) 2610/85 (11.8%) 110/2 (0%) 00/2 (0%) 0
    Infections and infestations
    Infection10/12 (83.3%) 379/13 (69.2%) 321/1 (100%) 61/1 (100%) 4114/213 (53.5%) 37554/85 (63.5%) 1691/2 (50%) 20/2 (0%) 0
    Metabolism and nutrition disorders
    Hyperglycemia0/12 (0%) 00/13 (0%) 00/1 (0%) 00/1 (0%) 012/213 (5.6%) 124/85 (4.7%) 40/2 (0%) 00/2 (0%) 0
    Nervous system disorders
    Neuropathy2/12 (16.7%) 21/13 (7.7%) 10/1 (0%) 00/1 (0%) 014/213 (6.6%) 155/85 (5.9%) 50/2 (0%) 01/2 (50%) 1
    Neurotoxicity2/12 (16.7%) 40/13 (0%) 00/1 (0%) 00/1 (0%) 011/213 (5.2%) 113/85 (3.5%) 30/2 (0%) 00/2 (0%) 0
    Renal and urinary disorders
    Cystitis6/12 (50%) 62/13 (15.4%) 21/1 (100%) 10/1 (0%) 025/213 (11.7%) 2511/85 (12.9%) 110/2 (0%) 00/2 (0%) 0
    Dialysis2/12 (16.7%) 20/13 (0%) 01/1 (100%) 10/1 (0%) 016/213 (7.5%) 168/85 (9.4%) 120/2 (0%) 00/2 (0%) 0
    Acute renal failure1/12 (8.3%) 10/13 (0%) 00/1 (0%) 00/1 (0%) 016/213 (7.5%) 167/85 (8.2%) 80/2 (0%) 00/2 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia5/12 (41.7%) 146/13 (46.2%) 81/1 (100%) 141/1 (100%) 191/213 (42.7%) 14342/85 (49.4%) 701/2 (50%) 12/2 (100%) 7
    Intubation3/12 (25%) 42/13 (15.4%) 20/1 (0%) 00/1 (0%) 034/213 (16%) 4514/85 (16.5%) 220/2 (0%) 01/2 (50%) 2
    Veno occlusive disease (VOD)2/12 (16.7%) 31/13 (7.7%) 10/1 (0%) 00/1 (0%) 015/213 (7%) 187/85 (8.2%) 100/2 (0%) 00/2 (0%) 0
    Pumonary hemorrhage1/12 (8.3%) 10/13 (0%) 01/1 (100%) 10/1 (0%) 016/213 (7.5%) 187/85 (8.2%) 70/2 (0%) 00/2 (0%) 0
    Sinusitis0/12 (0%) 00/13 (0%) 00/1 (0%) 00/1 (0%) 010/213 (4.7%) 106/85 (7.1%) 60/2 (0%) 00/2 (0%) 0
    Vascular disorders
    Hypertension2/12 (16.7%) 26/13 (46.2%) 60/1 (0%) 00/1 (0%) 026/213 (12.2%) 2721/85 (24.7%) 231/2 (50%) 10/2 (0%) 0

    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. Daniel J.Weisdorf, M.D
    OrganizationMasonic Cancer Center, University of Minnesota
    Phone612 624-3101
    Emailweisd001@umn.edu
    Responsible Party:
    Masonic Cancer Center, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT00176930
    Other Study ID Numbers:
    • 2001LS049
    • MT2001-02
    • 0107M05202
    • NCT00393133
    First Posted:
    Sep 15, 2005
    Last Update Posted:
    Jan 22, 2021
    Last Verified:
    Dec 1, 2020