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NCT01384513 · OUTCOME

Overall Survival (OS) in Patients With Haploidentical Family Donors With Hematological Malignancies in Morphological or Radiographic Remission or With Chemosensitive, Indolent Diseases

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At 2 years

What was measured

The primary null hypothesis is that 2 year OS rate is at most 35%. This hypothesis will be rejected if the 95% confidence interval for year OS rate computed from the estimated Kaplan-Meier survival curves will be entirely above 0.35.

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

Overall survival at 2 years

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Allogeneic PBSCT)31Not reportedNot reportedNot reportedNot reported

expired prior to 2 year survival window

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Allogeneic PBSCT)9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        31
      title
      Overall survival at 2 years
    2. measurements
      1. group Id
        OG000
        value
        9
      title
      expired prior to 2 year survival window
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    units
    Participants
description
The primary null hypothesis is that 2 year OS rate is at most 35%. This hypothesis will be rejected if the 95% confidence interval for year OS rate computed from the estimated Kaplan-Meier survival curves will be entirely above 0.35.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
At 2 years
title
Overall Survival (OS) in Patients With Haploidentical Family Donors With Hematological Malignancies in Morphological or Radiographic Remission or With Chemosensitive, Indolent Diseases
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice