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NCT01760655 · OUTCOME

Immune Reconstitution at Day +28

Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies · Source last updated 2025-10-30

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

Measure
MEAN
Unit
cells/mm³
Interval / dispersion
Standard Deviation
Time frame
Up to 1 year

What was measured

CD4 and CD8 values at Day +28. Reported as mean (standard deviation).

Analysis population: Participants surviving to Day +28 with evaluable data. This excludes the one subject who was a graft failure and anyone who died before 28 days.

Groups in this outcome

Treatment (RIC and allogeneic PBSCT)

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28 Fludarabine phosphate: Given IV Busulfan: Given IV Total-Body Irradiation: Undergo TBI Therapeutic Allogeneic Lymphocytes: Undergo DLI Cyclophosphamide: Given IV Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Tacrolimus: Given IV 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
Treatment (RIC and allogeneic PBSCT)56

Reported measurements

CD3/4 at Day +28
Values in cells/mm³ · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (RIC and allogeneic PBSCT)66.980.5Not reportedNot reportedNot reported
CD3/8 at Day +28
Values in cells/mm³ · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (RIC and allogeneic PBSCT)109.9137.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        80.5
        value
        66.9
    title
    CD3/4 at Day +28
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        137.4
        value
        109.9
    title
    CD3/8 at Day +28
denoms
  1. counts
    1. group Id
      OG000
      value
      56
    units
    Participants
description
CD4 and CD8 values at Day +28. Reported as mean (standard deviation).
dispersion Type
Standard Deviation
groups
  1. description
    REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28 Fludarabine phosphate: Given IV Busulfan: Given IV Total-Body Irradiation: Undergo TBI Therapeutic Allogeneic Lymphocytes: Undergo DLI Cyclophosphamide: Given IV Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Tacrolimus: Given IV Mycophenolate Mofetil: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    OG000
    title
    Treatment (RIC and allogeneic PBSCT)
param Type
MEAN
population Description
Participants surviving to Day +28 with evaluable data. This excludes the one subject who was a graft failure and anyone who died before 28 days.
reporting Status
POSTED
time Frame
Up to 1 year
title
Immune Reconstitution at Day +28
type
SECONDARY
unit Of Measure
cells/mm³

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

Preserved source evidence · Not medical advice