Skip to content
← Full study record

NCT00544115 · OUTCOME

Neutrophil Engraftment - The Days Till ANC Recovery

Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders · Source last updated 2026-06-02

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

Measure
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
Up to 180 days post transplant

What was measured

The primary engraftment endpoint, neutrophil engraftment, is defined as the first of three consecutive days on which the absolute neutrophil count is \> 500/µL. The duration and extent of neutrophil engraftment is the time from transplant to neutrophil engraftment.

Analysis population: Some patients had engraftment failure and some had missing data. Therefore, the overall number of participants analyzed in each regimen is less than the overall number in the Participant Flow module.

Groups in this outcome

Regimen I

Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1. cyclophosphamide cyclosporine methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation

Regimen II

Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2. busulfan cyclophosphamide cyclosporine methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation

Regimen III

Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3. cyclosporine etoposide methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation

Regimen IV

Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2. cyclosporine fludarabine phosphate melphalan methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation

Regimen V

Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0. cyclosporine fludarabine phosphate methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation

Regimen VI

Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2. busulfan cyclosporine fludarabine phosphate methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation

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

Analysis denominator · Participants

GroupSource count
Regimen I42
Regimen II13
Regimen III113
Regimen IV3
Regimen V36
Regimen VI1

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen I17Not reported1139Not reported
Regimen II16Not reported1321Not reported
Regimen III15Not reported836Not reported
Regimen IV14Not reported1417Not reported
Regimen V18Not reported1128Not reported
Regimen VI16Not reported1616Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11
        upper Limit
        39
        value
        17
      2. group Id
        OG001
        lower Limit
        13
        upper Limit
        21
        value
        16
      3. group Id
        OG002
        lower Limit
        8
        upper Limit
        36
        value
        15
      4. group Id
        OG003
        lower Limit
        14
        upper Limit
        17
        value
        14
      5. group Id
        OG004
        lower Limit
        11
        upper Limit
        28
        value
        18
      6. group Id
        OG005
        lower Limit
        16
        upper Limit
        16
        value
        16
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    2. group Id
      OG001
      value
      13
    3. group Id
      OG002
      value
      113
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      36
    6. group Id
      OG005
      value
      1
    units
    Participants
description
The primary engraftment endpoint, neutrophil engraftment, is defined as the first of three consecutive days on which the absolute neutrophil count is \> 500/µL. The duration and extent of neutrophil engraftment is the time from transplant to neutrophil engraftment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1. cyclophosphamide cyclosporine methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
    id
    OG000
    title
    Regimen I
  2. description
    Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2. busulfan cyclophosphamide cyclosporine methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
    id
    OG001
    title
    Regimen II
  3. description
    Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3. cyclosporine etoposide methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
    id
    OG002
    title
    Regimen III
  4. description
    Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2. cyclosporine fludarabine phosphate melphalan methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
    id
    OG003
    title
    Regimen IV
  5. description
    Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0. cyclosporine fludarabine phosphate methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
    id
    OG004
    title
    Regimen V
  6. description
    Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2. busulfan cyclosporine fludarabine phosphate methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
    id
    OG005
    title
    Regimen VI
param Type
MEDIAN
population Description
Some patients had engraftment failure and some had missing data. Therefore, the overall number of participants analyzed in each regimen is less than the overall number in the Participant Flow module.
reporting Status
POSTED
time Frame
Up to 180 days post transplant
title
Neutrophil Engraftment - The Days Till ANC Recovery
type
PRIMARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice