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NCT01640301 · OUTCOME

Disease-free Survival After T Cell Therapy

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 1 year

Groups in this outcome

Arm I (High-risk for Relapse After HCT)

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

Arm II (Relapsed After HCT)

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I (High-risk for Relapse After HCT)13
Arm II (Relapsed After HCT)15

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (High-risk for Relapse After HCT)13Not reportedNot reportedNot reportedNot reported
Arm II (Relapsed After HCT)7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        7
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      15
    units
    Participants
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
    OG000
    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
    OG001
    title
    Arm II (Relapsed After HCT)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 1 year
title
Disease-free Survival After T Cell Therapy
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice