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NCT01384513 · OUTCOME

Engraftment Rates

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
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
44 weeks

What was measured

Hematopoietic engraftment will be defined as: * ANC ≥ 0.5x10e9/L for at least 3 days * Platelet engraftment \>20,000 with no transfusion x 7 days.

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

Median Neutrophil Engraftment
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Treatment (Allogeneic PBSCT)12Not reported914Not reported
Median Platelet Engraftment
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Treatment (Allogeneic PBSCT)17Not reported12173Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9
        upper Limit
        14
        value
        12
    title
    Median Neutrophil Engraftment
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12
        upper Limit
        173
        value
        17
    title
    Median Platelet Engraftment
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    units
    Participants
description
Hematopoietic engraftment will be defined as: * ANC ≥ 0.5x10e9/L for at least 3 days * Platelet engraftment \>20,000 with no transfusion x 7 days.
dispersion Type
Full Range
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
MEDIAN
reporting Status
POSTED
time Frame
44 weeks
title
Engraftment Rates
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice