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NCT01384513 · OUTCOME

Treatment Related Mortality (TRM)

A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies · Source last updated 2026-04-15

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 2 years

What was measured

To compare the treatment related mortality rate (TRM) for patients treated on this study to the historical TRM rates of patients undergoing reduced intensity conditioning (RIC) matched-sibling hematopoietic stem cell transplant (HSCT) as reported in the literature

Groups in this outcome

Treatment (Allogeneic PBSCT)

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT

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 (Allogeneic PBSCT)40

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Allogeneic PBSCT)10Not reported3.121.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.1
        upper Limit
        21.7
        value
        10
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    units
    Participants
description
To compare the treatment related mortality rate (TRM) for patients treated on this study to the historical TRM rates of patients undergoing reduced intensity conditioning (RIC) matched-sibling hematopoietic stem cell transplant (HSCT) as reported in the literature
dispersion Type
95% Confidence Interval
groups
  1. description
    REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT
    id
    OG000
    title
    Treatment (Allogeneic PBSCT)
param Type
NUMBER
reporting Status
POSTED
time Frame
At 2 years
title
Treatment Related Mortality (TRM)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice