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NCT00589316 · OUTCOME

Number of Participants With Dose-limiting Toxicities (DLT) 30 Days After Transplant

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 30 days post-transplant

What was measured

The criteria of Grade III/IV regimen-related toxicity (Bearman) or dose-limiting toxicity (DLT) are as follows: Grade 1 Development of transient chemical abnormalities which are not of major clinical consequence and which reverse without requiring major medical interventions. In general, the intent of this toxicity scale is to observe transient target organ toxicity which is reversible. Grade 2 Development of chemical or laboratory abnormalities that are persistent and which may represent target organ damage that may not be readily reversed. It is anticipated that at this dose of the drug, the toxicity obtained would be manageable by clinical methods but may interfere with other therapies. Grade 3 Development of major clinical, chemical or laboratory abnormalities which represent maximum toxicities without being fatal. This grade of toxicity is designed to be the dose-limiting toxicity. Grade 4 Fatal

Analysis population: Number of participants that experienced a dose-limiting toxicity (DLT) within 30 days following transplant.

Groups in this outcome

Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody

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

Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody

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

Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody

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

Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody

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

Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody

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

Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody

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

Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody

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

Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody1
Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody1
Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody5
Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody1
Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody1
Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody2
Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody6
Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody8

Reported measurements

Source class 1

Number of participants with no dose-limiting toxicities 30 days after transplant

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody1Not reportedNot reportedNot reportedNot reported
Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody1Not reportedNot reportedNot reportedNot reported
Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody5Not reportedNot reportedNot reportedNot reported
Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody1Not reportedNot reportedNot reportedNot reported
Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody1Not reportedNot reportedNot reportedNot reported
Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody2Not reportedNot reportedNot reportedNot reported
Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody6Not reportedNot reportedNot reportedNot reported
Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody7Not reportedNot reportedNot reportedNot reported

Number of participants with dose-limiting toxicities 30 days after transplant

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody0Not reportedNot reportedNot reportedNot reported
Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody0Not reportedNot reportedNot reportedNot reported
Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody0Not reportedNot reportedNot reportedNot reported
Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody0Not reportedNot reportedNot reportedNot reported
Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody0Not reportedNot reportedNot reportedNot reported
Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody0Not reportedNot reportedNot reportedNot reported
Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody0Not reportedNot reportedNot reportedNot reported
Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        6
      8. group Id
        OG007
        value
        7
      title
      Number of participants with no dose-limiting toxicities 30 days after transplant
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        1
      title
      Number of participants with dose-limiting toxicities 30 days after transplant
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      2
    7. group Id
      OG006
      value
      6
    8. group Id
      OG007
      value
      8
    units
    Participants
description
The criteria of Grade III/IV regimen-related toxicity (Bearman) or dose-limiting toxicity (DLT) are as follows: Grade 1 Development of transient chemical abnormalities which are not of major clinical consequence and which reverse without requiring major medical interventions. In general, the intent of this toxicity scale is to observe transient target organ toxicity which is reversible. Grade 2 Development of chemical or laboratory abnormalities that are persistent and which may represent target organ damage that may not be readily reversed. It is anticipated that at this dose of the drug, the toxicity obtained would be manageable by clinical methods but may interfere with other therapies. Grade 3 Development of major clinical, chemical or laboratory abnormalities which represent maximum toxicities without being fatal. This grade of toxicity is designed to be the dose-limiting toxicity. Grade 4 Fatal
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
    OG000
    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
    OG001
    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
    OG002
    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
    OG003
    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
    OG004
    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
    OG005
    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
    OG006
    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
    OG007
    title
    Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody
param Type
COUNT_OF_PARTICIPANTS
population Description
Number of participants that experienced a dose-limiting toxicity (DLT) within 30 days following transplant.
reporting Status
POSTED
time Frame
Up to 30 days post-transplant
title
Number of Participants With Dose-limiting Toxicities (DLT) 30 Days After Transplant
type
PRIMARY
unit Of Measure
Participants

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