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NCT01640301 · FLOW

Participant flow

Laboratory-Treated T Cells in Treating Patients With High-Risk Relapsed Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Previously Treated With Donor Stem Cell Transplant · Source last updated 2022-07-14

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

groups
  1. description
    Patients with no evidence of leukemia or MDS post-HCT receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 14 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
    id
    FG000
    title
    Arm I (High-risk for Relapse After HCT)
  2. description
    Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
    id
    FG001
    title
    Arm II (Relapsed After HCT)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        15
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        7
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
47 participants were enrolled on the study, meaning they signed the consent for treatment. However, 19 did not move on to treatment for various reasons.
Complete source fields
groups
  1. description
    Patients with no evidence of leukemia or MDS post-HCT receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 14 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
    id
    FG000
    title
    Arm I (High-risk for Relapse After HCT)
  2. description
    Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
    id
    FG001
    title
    Arm II (Relapsed After HCT)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        15
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        7
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
47 participants were enrolled on the study, meaning they signed the consent for treatment. However, 19 did not move on to treatment for various reasons.

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

Preserved source evidence · Not medical advice