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NCT02593123 · OUTCOME

Determine the Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) With Diagnosis of Engraftment Loss.

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
60 Days Following Stem Cell Transplant

What was measured

Number of patients with engraftment loss.

Groups in this outcome

Arm I (MMF-15, Sargramostim)

Patients receive mycophenolate mofetil (MMF) PO or IV BID on days 0-15 and sargramostim 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 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

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

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (MMF-15, Sargramostim)0Not reportedNot reportedNot reportedNot reported
Arm II (MMF-30, Filgrastim)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      11
    units
    Participants
description
Number of patients with engraftment loss.
groups
  1. description
    Patients receive mycophenolate mofetil (MMF) PO or IV BID on days 0-15 and sargramostim 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)
  2. description
    Patients receive mycophenolate mofetil PO or IV 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
60 Days Following Stem Cell Transplant
title
Determine the Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) With Diagnosis of Engraftment Loss.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice