NCT02593123 · OUTCOME

The Number of Patients With Relapse-free/Donor Lymphocyte Infusion(DLI)-Free Survival Rates Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort).

Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis · Source last updated 2023-01-23

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 2 years following stem cell transplant

What was measured

The primary outcome in this study is event-free survival, where the conditional events are the occurrence of relapse DLI.

Groups in this outcome

Arm I (MMF-15, Sargramostim)

Patients receive mycophenolate mofetil (MMF) PO or IV twice daily (BID) on days 0-15 and sargramostim subcutaneous (SC) from post-transplant day 4 until neutrophil engraftment. mycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration. Sargramostim: GM-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-15 cohort will receive sargramostim (GM-CSF) 250 mcg/m2/day beginning on post-transplant day 4 and continuing until neutrophil engraftment. Patients receiving GM-CSF will also receive inhaled corticosteroids, fluticasone (Flovent) 2 puffs twice daily, starting on post-transplant day 4 and stopping after cessation of GM-CSF, to diminish the risk of pneumonitis. Note: At investigator discretion, patients in the MMF-15 cohort who have preexisting pulmonary risk factors, will be permitted to receive G-CSF.

Arm II (MMF-30, Filgrastim)

Patients receive mycophenolate mofetil PO or IV twice daily (BID) on days 0-30 and filgrastim from post-transplant day 4 until neutrophil engraftment. mycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration. Filgrastim: G-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-30 cohort will receive filgrastim (G-CSF) 5 mcg/kg/day beginning on post-transplant day 4 and continuing until neutrophil engraftment.

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
Arm I (MMF-15, Sargramostim)	15
Arm II (MMF-30, Filgrastim)	11

Reported measurements

Source class 1

Event Free Survival Yes

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (MMF-15, Sargramostim)	7	Not reported	Not reported	Not reported	Not reported
Arm II (MMF-30, Filgrastim)	4	Not reported	Not reported	Not reported	Not reported

Event Free Survival No

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (MMF-15, Sargramostim)	8	Not reported	Not reported	Not reported	Not reported
Arm II (MMF-30, Filgrastim)	7	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
7
group Id
OG001
value
4
title
Event Free Survival Yes
measurements
group Id
OG000
value
8
group Id
OG001
value
7
title
Event Free Survival No

denoms

counts
group Id
OG000
value
15
group Id
OG001
value
11
units
Participants

description

The primary outcome in this study is event-free survival, where the conditional events are the occurrence of relapse DLI.

groups

description
Patients receive mycophenolate mofetil (MMF) PO or IV twice daily (BID) on days 0-15 and sargramostim subcutaneous (SC) from post-transplant day 4 until neutrophil engraftment. mycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration. Sargramostim: GM-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-15 cohort will receive sargramostim (GM-CSF) 250 mcg/m2/day beginning on post-transplant day 4 and continuing until neutrophil engraftment. Patients receiving GM-CSF will also receive inhaled corticosteroids, fluticasone (Flovent) 2 puffs twice daily, starting on post-transplant day 4 and stopping after cessation of GM-CSF, to diminish the risk of pneumonitis. Note: At investigator discretion, patients in the MMF-15 cohort who have preexisting pulmonary risk factors, will be permitted to receive G-CSF.
id
OG000
title
Arm I (MMF-15, Sargramostim)
description
Patients receive mycophenolate mofetil PO or IV twice daily (BID) on days 0-30 and filgrastim from post-transplant day 4 until neutrophil engraftment. mycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration. Filgrastim: G-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-30 cohort will receive filgrastim (G-CSF) 5 mcg/kg/day beginning on post-transplant day 4 and continuing until neutrophil engraftment.
id
OG001
title
Arm II (MMF-30, Filgrastim)

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

Up to 2 years following stem cell transplant

title

The Number of Patients With Relapse-free/Donor Lymphocyte Infusion(DLI)-Free Survival Rates Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort).

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice