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NCT02593123 · OUTCOME

Differences in the Rates of T-cell Recovery Kinetics Following Stem Cell Transplantation (SCT) 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
MEAN
Unit
10^3 *cells* per microliter
Interval / dispersion
Standard Deviation
Time frame
100 Days Following Stem Cell Transplantation

What was measured

Number of T Cells 10E3 per microL per arm indicating rates of T-cell recovery by Day 100 following SCT.

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 10^3 *cells* per microliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm I (MMF-15, Sargramostim)313.656.5Not reportedNot reportedNot reported
Arm II (MMF-30, Filgrastim)222.281.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        56.5
        value
        313.6
      2. group Id
        OG001
        spread
        81.3
        value
        222.2
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      11
    units
    Participants
description
Number of T Cells 10E3 per microL per arm indicating rates of T-cell recovery by Day 100 following SCT.
dispersion Type
Standard Deviation
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
MEAN
reporting Status
POSTED
time Frame
100 Days Following Stem Cell Transplantation
title
Differences in the Rates of T-cell Recovery Kinetics Following Stem Cell Transplantation (SCT) Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort).
type
SECONDARY
unit Of Measure
10^3 *cells* per microliter

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

Preserved source evidence · Not medical advice