NCT02593123 · OUTCOME
The Difference Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Day 60 Donor-derived (dd) Cluster of Differentiation (CD)3 10E3per microL Counts.
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 Error
- Time frame
- 60 Days Following Stem Cell Transplant
What was measured
Day 60 donor-derived (dd) cluster of differentiation (CD)3 counts measured by 10E3per microL.
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 | Source count |
|---|---|
| Arm I (MMF-15, Sargramostim) | 15 |
| Arm II (MMF-30, Filgrastim) | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (MMF-15, Sargramostim) | 383.0 | 539 | Not reported | Not reported | Not reported |
| Arm II (MMF-30, Filgrastim) | 254.1 | 375 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 539
- value
- 383.0
- group Id
- OG001
- spread
- 375
- value
- 254.1
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 11
- units
- Participants
- description
- Day 60 donor-derived (dd) cluster of differentiation (CD)3 counts measured by 10E3per microL.
- dispersion Type
- Standard Error
- groups
- 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)
- 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
- 60 Days Following Stem Cell Transplant
- title
- The Difference Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Day 60 Donor-derived (dd) Cluster of Differentiation (CD)3 10E3per microL Counts.
- type
- SECONDARY
- unit Of Measure
- 10^3 *cells* per microliter
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Preserved source evidence · Not medical advice
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