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NCT01760655 · OUTCOME

Disease-free Survival (DFS)

Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies · Source last updated 2025-10-30

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

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
1 year post hematopoietic stem cell transplant (HSCT)

What was measured

This hypothesis will be rejected if the 95% confidence interval for year DFS rate computed from the estimated Kaplan-Meier survival curves will be entirely above 0.35.

Groups in this outcome

Treatment (RIC and allogeneic PBSCT)

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28 Fludarabine phosphate: Given IV Busulfan: Given IV Total-Body Irradiation: Undergo TBI Therapeutic Allogeneic Lymphocytes: Undergo DLI Cyclophosphamide: Given IV Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Tacrolimus: Given IV Mycophenolate Mofetil: Given IV Laboratory Biomarker Analysis: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Treatment (RIC and allogeneic PBSCT)62

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (RIC and allogeneic PBSCT).5Not reported.368.618Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        .368
        upper Limit
        .618
        value
        .5
denoms
  1. counts
    1. group Id
      OG000
      value
      62
    units
    Participants
description
This hypothesis will be rejected if the 95% confidence interval for year DFS rate computed from the estimated Kaplan-Meier survival curves will be entirely above 0.35.
dispersion Type
95% Confidence Interval
groups
  1. description
    REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28 Fludarabine phosphate: Given IV Busulfan: Given IV Total-Body Irradiation: Undergo TBI Therapeutic Allogeneic Lymphocytes: Undergo DLI Cyclophosphamide: Given IV Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Tacrolimus: Given IV Mycophenolate Mofetil: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    OG000
    title
    Treatment (RIC and allogeneic PBSCT)
param Type
NUMBER
reporting Status
POSTED
time Frame
1 year post hematopoietic stem cell transplant (HSCT)
title
Disease-free Survival (DFS)
type
PRIMARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice