TriangleNCT02593123 · STUDY IN CONTEXT
Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
The primary outcome in this study is event-free survival, where the conditional events are the occurrence of relapse DLI.
Day 60 donor-derived (dd) cluster of differentiation (CD)3 counts measured by 10E3per microL.
Overall survival (days to event or survival: time-to-event; survival: categorical)
The number of patients diagnosed with acute acute GVHD between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort)
The differences in the rates of chronic GVHD between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort)
The number of patients diagnosed with an opportunistic infections.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- trial label
- Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0000
- source section id
- NCT02593123-om-0000
- source outcome index
- 0
- endpoint
- 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).
- endpoint definition
- The primary outcome in this study is event-free survival, where the conditional events are the occurrence of relapse DLI.
- time origin
- Up to 2 years following stem cell transplant
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0001
- source section id
- NCT02593123-om-0001
- source outcome index
- 1
- endpoint
- 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.
- endpoint definition
- Day 60 donor-derived (dd) cluster of differentiation (CD)3 counts measured by 10E3per microL.
- time origin
- 60 Days Following Stem Cell Transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0002
- source section id
- NCT02593123-om-0002
- source outcome index
- 2
- endpoint
- The Probability of Overall Survival (OS) Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort)
- endpoint definition
- Overall survival (days to event or survival: time-to-event; survival: categorical)
- time origin
- Randomization up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0003
- source section id
- NCT02593123-om-0003
- source outcome index
- 3
- endpoint
- Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) With Acute Graft Vs Host Disease (GVHD)
- endpoint definition
- The number of patients diagnosed with acute acute GVHD between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort)
- time origin
- 60 Days following stem cell transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0004
- source section id
- NCT02593123-om-0004
- source outcome index
- 4
- endpoint
- Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Diagnosed With Chronic Graft vs Host Disease (GVHD)
- endpoint definition
- The differences in the rates of chronic GVHD between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort)
- time origin
- 60 Days following stem cell transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0005
- source section id
- NCT02593123-om-0005
- source outcome index
- 5
- endpoint
- Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Diagnosed With Opportunistic Infections
- endpoint definition
- The number of patients diagnosed with an opportunistic infections.
- time origin
- 60 Days following stem cell transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I (MMF-15, Sargramostim)
- regimen
- 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.
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02593123-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II (MMF-30, Filgrastim)
- regimen
- 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.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02593123-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I (MMF-15, Sargramostim)
- regimen
- 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.
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02593123-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm II (MMF-30, Filgrastim)
- regimen
- 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.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02593123-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I (MMF-15, Sargramostim)
- regimen
- 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.
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02593123-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm II (MMF-30, Filgrastim)
- regimen
- 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.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02593123-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm I (MMF-15, Sargramostim)
- regimen
- 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.
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02593123-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm II (MMF-30, Filgrastim)
- regimen
- 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.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02593123-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm I (MMF-15, Sargramostim)
- regimen
- 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.
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02593123-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm II (MMF-30, Filgrastim)
- regimen
- 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.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02593123-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Arm I (MMF-15, Sargramostim)
- regimen
- 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.
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02593123-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Arm II (MMF-30, Filgrastim)
- regimen
- 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.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02593123-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- harm key
- EG000
- source section id
- NCT02593123-ae
- event group key
- EG000
- event group label
- Arm I (MMF-15, Sargramostim)
- serious affected
- 15
- serious at risk
- 15
- other affected
- 15
- other at risk
- 15
- frequency threshold
- 0
- collection period
- All Cause Mortality assessed for 2 years. Serious Adverse Events (SAE's) and Adverse Events (AE's) (Other, not included serious) assessed for 6 months.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-lymphoid-leukemia
- nct id
- NCT02593123
- harm key
- EG001
- source section id
- NCT02593123-ae
- event group key
- EG001
- event group label
- Arm II (MMF-30, Filgrastim)
- serious affected
- 11
- serious at risk
- 11
- other affected
- 10
- other at risk
- 11
- frequency threshold
- 0
- collection period
- All Cause Mortality assessed for 2 years. Serious Adverse Events (SAE's) and Adverse Events (AE's) (Other, not included serious) assessed for 6 months.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice