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NCT00589316 · BASELINE

Baseline characteristics

Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or High-Risk Myelodysplastic Syndrome · Source last updated 2023-02-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      1
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      5
    4. group Id
      BG003
      value
      1
    5. group Id
      BG004
      value
      1
    6. group Id
      BG005
      value
      2
    7. group Id
      BG006
      value
      7
    8. group Id
      BG007
      value
      7
    9. group Id
      BG008
      value
      25
    units
    Participants
groups
  1. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG000
    title
    Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody
  2. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG001
    title
    Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody
  3. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG002
    title
    Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody
  4. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG003
    title
    Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody
  5. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG004
    title
    Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody
  6. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG005
    title
    Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody
  7. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG006
    title
    Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody
  8. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG007
    title
    Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          22
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          3
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    This is a dose-escalation study.
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          16
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          24
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          15
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          25
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      5
    4. group Id
      BG003
      value
      1
    5. group Id
      BG004
      value
      1
    6. group Id
      BG005
      value
      2
    7. group Id
      BG006
      value
      7
    8. group Id
      BG007
      value
      7
    9. group Id
      BG008
      value
      25
    units
    Participants
groups
  1. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG000
    title
    Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody
  2. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG001
    title
    Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody
  3. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG002
    title
    Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody
  4. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG003
    title
    Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody
  5. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG004
    title
    Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody
  6. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG005
    title
    Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody
  7. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG006
    title
    Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody
  8. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    BG007
    title
    Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          22
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          3
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    This is a dose-escalation study.
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          16
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          24
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          15
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          25
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice