NCT01760655 · OUTCOME

Immune Reconstitution at Day +90

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 +90. Reported as mean (standard deviation).

Analysis population: Participants surviving to Day +90 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

Group	Source count
Treatment (RIC and allogeneic PBSCT)	44

Reported measurements

CD3/4 at Day +90

Values in cells/mm³ · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (RIC and allogeneic PBSCT)	173.7	136.1	Not reported	Not reported	Not reported

CD3/8 at Day +90

Values in cells/mm³ · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (RIC and allogeneic PBSCT)	343.1	395.4	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
136.1
value
173.7
title
CD3/4 at Day +90
categories
measurements
group Id
OG000
spread
395.4
value
343.1
title
CD3/8 at Day +90

denoms

counts
group Id
OG000
value
44
units
Participants

description

CD4 and CD8 values at Day +90. Reported as mean (standard deviation).

dispersion Type

Standard Deviation

groups

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 +90 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 +90

type

SECONDARY

unit Of Measure

cells/mm³

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

Preserved source evidence · Not medical advice