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NCT00075478 · FLOW

Participant flow

Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer · Source last updated 2017-05-15

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

groups
  1. description
    Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
    id
    FG000
    title
    Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
  2. description
    Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
    id
    FG001
    title
    Arm II (TBI, Transplant, GVHD Prophylaxis)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      not eligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        45
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        44
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
    id
    FG000
    title
    Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
  2. description
    Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
    id
    FG001
    title
    Arm II (TBI, Transplant, GVHD Prophylaxis)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      not eligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        45
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        44
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice