NCT01036009 · OUTCOME

Time Until Late Relapse

A Study of Withdrawal of Immunosuppression and Donor Lymphocyte Infusions Following Allogeneic Transplant for Pediatric Hematologic Malignancies · Source last updated 2016-06-23

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

Measure: MEAN
Unit: months
Interval / dispersion: Full Range
Time frame: 24-36 months post-transplant

What was measured

Number of months post-transplant until late relapse, in intervention patients relapsing after the 2-year primary study endpoint. Relapse defined as \>5% blasts in bone marrow

Analysis population: intervention patients who relapsed after the 2 year primary study endpoint

Groups in this outcome

Group II: Intervention

Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I. Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved.

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
Group II: Intervention	4

Reported measurements

Source class 1

Values in months · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Group II: Intervention	32.025	Not reported	25	36.32	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
25
upper Limit
36.32
value
32.025

denoms

counts
group Id
OG000
value
4
units
Participants

description

Number of months post-transplant until late relapse, in intervention patients relapsing after the 2-year primary study endpoint. Relapse defined as \>5% blasts in bone marrow

dispersion Type

Full Range

groups

description
Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I. Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved.
id
OG000
title
Group II: Intervention

param Type

MEAN

population Description

intervention patients who relapsed after the 2 year primary study endpoint

reporting Status

POSTED

time Frame

24-36 months post-transplant

title

Time Until Late Relapse

type

POST_HOC

unit Of Measure

months

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

Preserved source evidence · Not medical advice