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NCT02566304 · OUTCOME

Relapse Related Mortality (RRM)

Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies · Source last updated 2025-04-24

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
At 1 year post HSCT

What was measured

Will be reported descriptively. RRM may also be estimated using Kaplan Meier curves and/or cumulative incidence analyses.

Groups in this outcome

RIC HSCT, GVHD Prophylaxis

RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6. TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD. Fludarabine: Given IV Total-Body Irradiation: Undergo TBI T Cell-Depleted Donor Lymphocyte Infusion: Undergo DLI Cyclophosphamide: Given IV Peripheral Blood Stem Cell Transplantation: Undergo PBSC transplant Allogeneic Hematopoietic Stem Cell Transplantation: Undergo PBSC transplant Tacrolimus: Given PO 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
RIC HSCT, GVHD Prophylaxis35

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RIC HSCT, GVHD Prophylaxis13Not reported428Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4
        upper Limit
        28
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
Will be reported descriptively. RRM may also be estimated using Kaplan Meier curves and/or cumulative incidence analyses.
dispersion Type
95% Confidence Interval
groups
  1. description
    RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6. TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD. Fludarabine: Given IV Total-Body Irradiation: Undergo TBI T Cell-Depleted Donor Lymphocyte Infusion: Undergo DLI Cyclophosphamide: Given IV Peripheral Blood Stem Cell Transplantation: Undergo PBSC transplant Allogeneic Hematopoietic Stem Cell Transplantation: Undergo PBSC transplant Tacrolimus: Given PO Mycophenolate mofetil: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    OG000
    title
    RIC HSCT, GVHD Prophylaxis
param Type
NUMBER
reporting Status
POSTED
time Frame
At 1 year post HSCT
title
Relapse Related Mortality (RRM)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice