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NCT00119366 · OUTCOME

Severity of Acute GVHD in Patients Who Completed the Study Treatment

Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Total Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome · Source last updated 2022-12-12

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
100 days after transplant

What was measured

The severity of acute GVHD is measured based on Graft-vs-Host Disease: Severity of GVHD Grade I +1 to +2 skin rash No gut or liver involvement Grade II +3 skin rash or * 1 gastrointestinal involvement and/or +1 liver involvement Grade III +2 to +4 gastrointestinal involvement and/or * 2 to +4 liver involvement with or without a rash Grade IV Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

Analysis population: Study participants that completed study treatment

Groups in this outcome

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

RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies

Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody

RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies

Dose Level 8: 24 Gy Iodine-131 + BC8 Monoclonal Antibody

RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies

Dose Level 9: 26 Gy Iodine-131 + BC8 Monoclonal Antibody

RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies

Dose Level 10: 28 Gy Iodine-131 + BC8 Monoclonal Antibody

RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies

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 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody2
Dose Level 8: 24 Gy Iodine-131 + BC8 Monoclonal Antibody3
Dose Level 9: 26 Gy Iodine-131 + BC8 Monoclonal Antibody2
Dose Level 10: 28 Gy Iodine-131 + BC8 Monoclonal Antibody8

Reported measurements

Source class 1

Number of participants with Grade 0-1 GVHD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody0Not reportedNot reportedNot reportedNot reported
Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody0Not reportedNot reportedNot reportedNot reported
Dose Level 8: 24 Gy Iodine-131 + BC8 Monoclonal Antibody0Not reportedNot reportedNot reportedNot reported
Dose Level 9: 26 Gy Iodine-131 + BC8 Monoclonal Antibody0Not reportedNot reportedNot reportedNot reported
Dose Level 10: 28 Gy Iodine-131 + BC8 Monoclonal Antibody3Not reportedNot reportedNot reportedNot reported

Number of participants with Grade 2 GVHD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody1Not reportedNot reportedNot reportedNot reported
Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody2Not reportedNot reportedNot reportedNot reported
Dose Level 8: 24 Gy Iodine-131 + BC8 Monoclonal Antibody3Not reportedNot reportedNot reportedNot reported
Dose Level 9: 26 Gy Iodine-131 + BC8 Monoclonal Antibody2Not reportedNot reportedNot reportedNot reported
Dose Level 10: 28 Gy Iodine-131 + BC8 Monoclonal Antibody4Not reportedNot reportedNot reportedNot reported

Number of participants with Grade 3 GVHD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody0Not reportedNot reportedNot reportedNot reported
Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody0Not reportedNot reportedNot reportedNot reported
Dose Level 8: 24 Gy Iodine-131 + BC8 Monoclonal Antibody0Not reportedNot reportedNot reportedNot reported
Dose Level 9: 26 Gy Iodine-131 + BC8 Monoclonal Antibody0Not reportedNot reportedNot reportedNot reported
Dose Level 10: 28 Gy Iodine-131 + BC8 Monoclonal Antibody1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. 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
        3
      title
      Number of participants with Grade 0-1 GVHD
    2. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        4
      title
      Number of participants with Grade 2 GVHD
    3. 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
        1
      title
      Number of participants with Grade 3 GVHD
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      8
    units
    Participants
description
The severity of acute GVHD is measured based on Graft-vs-Host Disease: Severity of GVHD Grade I +1 to +2 skin rash No gut or liver involvement Grade II +3 skin rash or * 1 gastrointestinal involvement and/or +1 liver involvement Grade III +2 to +4 gastrointestinal involvement and/or * 2 to +4 liver involvement with or without a rash Grade IV Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
groups
  1. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies
    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 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies
    id
    OG001
    title
    Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody
  3. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies
    id
    OG002
    title
    Dose Level 8: 24 Gy Iodine-131 + BC8 Monoclonal Antibody
  4. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies
    id
    OG003
    title
    Dose Level 9: 26 Gy Iodine-131 + BC8 Monoclonal Antibody
  5. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies
    id
    OG004
    title
    Dose Level 10: 28 Gy Iodine-131 + BC8 Monoclonal Antibody
param Type
COUNT_OF_PARTICIPANTS
population Description
Study participants that completed study treatment
reporting Status
POSTED
time Frame
100 days after transplant
title
Severity of Acute GVHD in Patients Who Completed the Study Treatment
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice