NCT01427881 · OUTCOME

Grades II-IV and III-IV Acute GVHD

Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies · Source last updated 2017-05-19

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

Measure: NUMBER
Unit: percentage of patients
Interval / dispersion: Not reported
Time frame: Through day +100 post-transplant

What was measured

Grades II-IV and III-IV GVHD will be assessed with the use of cumulative incidence plots.

Groups in this outcome

Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)

PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT

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 (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)	43

Reported measurements

Grades II-IV GVHD

Values in percentage of patients · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)	77	Not reported	Not reported	Not reported	Not reported

Grades III-IV GVHD

Values in percentage of patients · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
77
title
Grades II-IV GVHD
categories
measurements
group Id
OG000
value
0
title
Grades III-IV GVHD

denoms

counts
group Id
OG000
value
43
units
Participants

description

Grades II-IV and III-IV GVHD will be assessed with the use of cumulative incidence plots.

groups

description
PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
id
OG000
title
Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)

param Type

NUMBER

reporting Status

POSTED

time Frame

Through day +100 post-transplant

title

Grades II-IV and III-IV Acute GVHD

type

SECONDARY

unit Of Measure

percentage of patients

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

Preserved source evidence · Not medical advice