NCT02458235 · OUTCOME

Proportion of Participants With Acute and Chronic Graft Versus Host Disease (GVHD)

Donor Lymphocyte Infusion With Azacitidine to Prevent Hematologic Malignancy Relapse After Stem Cell Transplantation · Source last updated 2020-10-12

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

Measure: NUMBER
Unit: proportion of participants
Interval / dispersion: Not reported
Time frame: Up to 2 years

What was measured

Proportion of participants with Grade 3-4 acute GVHD and moderate to severe chronic GVHD will be reported.

Groups in this outcome

Azacitidine/Donor Lymphocyte Infusion

Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI. azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.

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
Azacitidine/Donor Lymphocyte Infusion	17

Reported measurements

Acute GVHD

Values in proportion of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Azacitidine/Donor Lymphocyte Infusion	0.176	Not reported	Not reported	Not reported	Not reported

Moderate to severe chronic GVHD

Values in proportion of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Azacitidine/Donor Lymphocyte Infusion	0.411	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0.176
title
Acute GVHD
categories
measurements
group Id
OG000
value
0.411
title
Moderate to severe chronic GVHD

denoms

counts
group Id
OG000
value
17
units
Participants

description

Proportion of participants with Grade 3-4 acute GVHD and moderate to severe chronic GVHD will be reported.

groups

description
Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI. azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.
id
OG000
title
Azacitidine/Donor Lymphocyte Infusion

param Type

NUMBER

reporting Status

POSTED

time Frame

Up to 2 years

title

Proportion of Participants With Acute and Chronic Graft Versus Host Disease (GVHD)

type

PRIMARY

unit Of Measure

proportion of participants

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

Preserved source evidence · Not medical advice