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NCT01231412 · FLOW

Participant flow

Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant · Source last updated 2026-04-30

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

groups
  1. description
    Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Total-Body Irradiation: Undergo TBI
    id
    FG000
    title
    Arm I (MMF and CSP)
  2. description
    Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Sirolimus: Given PO Total-Body Irradiation: Undergo TBI
    id
    FG001
    title
    Arm II (MMF, CSP, and Sirolimus)
  3. description
    Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
    id
    FG002
    title
    Arm 0 (CSP and Sirolimus)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        77
      2. group Id
        FG001
        num Subjects
        91
      3. group Id
        FG002
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        77
      2. group Id
        FG001
        num Subjects
        90
      3. group Id
        FG002
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Total-Body Irradiation: Undergo TBI
    id
    FG000
    title
    Arm I (MMF and CSP)
  2. description
    Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Sirolimus: Given PO Total-Body Irradiation: Undergo TBI
    id
    FG001
    title
    Arm II (MMF, CSP, and Sirolimus)
  3. description
    Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
    id
    FG002
    title
    Arm 0 (CSP and Sirolimus)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        77
      2. group Id
        FG001
        num Subjects
        91
      3. group Id
        FG002
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        77
      2. group Id
        FG001
        num Subjects
        90
      3. group Id
        FG002
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice