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NCT01118013 · FLOW

Participant flow

Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant · Source last updated 2017-03-24

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

groups
  1. description
    Participants will receive: Busulfan test dose of 25 mg/m\^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m\^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m\^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC \> 1000/mL for 3 consecutive days.
    id
    FG000
    title
    Treatment
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Between May 2010 and March 2012, 6 participants were recruited.
Complete source fields
groups
  1. description
    Participants will receive: Busulfan test dose of 25 mg/m\^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m\^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m\^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC \> 1000/mL for 3 consecutive days.
    id
    FG000
    title
    Treatment
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Between May 2010 and March 2012, 6 participants were recruited.

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

Preserved source evidence · Not medical advice