Trial Outcomes & Findings for Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis (NCT NCT02593123)
NCT ID: NCT02593123
Last Updated: 2023-01-23
Results Overview
The primary outcome in this study is event-free survival, where the conditional events are the occurrence of relapse DLI.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Up to 2 years following stem cell transplant
Results posted on
2023-01-23
Participant Flow
Participant milestones
| Measure |
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 G-CSF 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.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
13
|
|
Overall Study
COMPLETED
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
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 G-CSF 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.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Relapse
|
1
|
1
|
Baseline Characteristics
Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis
Baseline characteristics by cohort
| Measure |
Arm I (MMF-15, Sargramostim)
n=15 Participants
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)
n=11 Participants
Patients receive mycophenolate mofetil PO or IV BID on days 0-30 and filgrastim GCSF 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.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years following stem cell transplantThe primary outcome in this study is event-free survival, where the conditional events are the occurrence of relapse DLI.
Outcome measures
| Measure |
Arm I (MMF-15, Sargramostim)
n=15 Participants
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)
n=11 Participants
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.
|
|---|---|---|
|
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).
Event Free Survival Yes
|
7 Participants
|
4 Participants
|
|
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).
Event Free Survival No
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 60 Days Following Stem Cell TransplantDay 60 donor-derived (dd) cluster of differentiation (CD)3 counts measured by 10E3per microL.
Outcome measures
| Measure |
Arm I (MMF-15, Sargramostim)
n=15 Participants
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)
n=11 Participants
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.
|
|---|---|---|
|
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.
|
383.0 10^3 *cells* per microliter
Standard Error 539
|
254.1 10^3 *cells* per microliter
Standard Error 375
|
SECONDARY outcome
Timeframe: Randomization up to 2 yearsOverall survival (days to event or survival: time-to-event; survival: categorical)
Outcome measures
| Measure |
Arm I (MMF-15, Sargramostim)
n=15 Participants
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)
n=9 Participants
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.
|
|---|---|---|
|
The Probability of Overall Survival (OS) Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort)
|
0.78 Probablility of 2 year survival
|
0.5 Probablility of 2 year survival
|
SECONDARY outcome
Timeframe: 60 Days following stem cell transplantThe number of patients diagnosed with acute acute GVHD between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort)
Outcome measures
| Measure |
Arm I (MMF-15, Sargramostim)
n=15 Participants
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)
n=11 Participants
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.
|
|---|---|---|
|
Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) With Acute Graft Vs Host Disease (GVHD)
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 60 Days following stem cell transplantThe differences in the rates of chronic GVHD between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort)
Outcome measures
| Measure |
Arm I (MMF-15, Sargramostim)
n=15 Participants
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)
n=11 Participants
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.
|
|---|---|---|
|
Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Diagnosed With Chronic Graft vs Host Disease (GVHD)
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 60 Days following stem cell transplantThe number of patients diagnosed with an opportunistic infections.
Outcome measures
| Measure |
Arm I (MMF-15, Sargramostim)
n=15 Participants
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)
n=11 Participants
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.
|
|---|---|---|
|
Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Diagnosed With Opportunistic Infections
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 60 Days Following Stem Cell TransplantNumber of patients with engraftment loss.
Outcome measures
| Measure |
Arm I (MMF-15, Sargramostim)
n=15 Participants
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)
n=11 Participants
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.
|
|---|---|---|
|
Determine the Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) With Diagnosis of Engraftment Loss.
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 60 Days Following Stem Cell TransplantNumber of patients diagnosed with engraftment syndrome.
Outcome measures
| Measure |
Arm I (MMF-15, Sargramostim)
n=15 Participants
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)
n=11 Participants
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.
|
|---|---|---|
|
Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort)Diagnosed With Differences in the Rates of Engraftment Syndrome.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 100 Days following Stem Cell TransplantNumber of patients that achieved donor chimerisms by day 100.
Outcome measures
| Measure |
Arm I (MMF-15, Sargramostim)
n=15 Participants
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)
n=11 Participants
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.
|
|---|---|---|
|
Differences in the Rates of Achieving Donor Chimerisms (the Percentage of DNA in the Sample Which Comes From the Donor) Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort).
|
15 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 100 Days Following Stem Cell TransplantationNumber of T Cells 10E3 per microL per arm indicating rates of T-cell recovery by Day 100 following SCT.
Outcome measures
| Measure |
Arm I (MMF-15, Sargramostim)
n=15 Participants
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)
n=11 Participants
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.
|
|---|---|---|
|
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).
|
313.6 10^3 *cells* per microliter
Standard Deviation 56.5
|
222.2 10^3 *cells* per microliter
Standard Deviation 81.3
|
Adverse Events
Arm I (MMF-15, Sargramostim)
Serious events: 15 serious events
Other events: 15 other events
Deaths: 4 deaths
Arm II (MMF-30, Filgrastim)
Serious events: 11 serious events
Other events: 10 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Arm I (MMF-15, Sargramostim)
n=15 participants at risk
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)
n=11 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Lung Infection
|
13.3%
2/15 • Number of events 2 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Infections and infestations
Catheter Infection
|
20.0%
3/15 • Number of events 3 • 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.
|
18.2%
2/11 • Number of events 2 • 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.
|
|
Cardiac disorders
cardiac disorders, other
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Surgical and medical procedures
surgical and medical procedures, other
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Infections and infestations
abdominal infection
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Cardiac disorders
cardiac arrest
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/15 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/15 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Investigations
Alanine Aminotransferase
|
0.00%
0/15 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Anal Fistula
|
0.00%
0/15 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Hepatobiliary disorders
Cholecystitis
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Gastrointestinal disorders
Colitis
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Gastrointestinal disorders
Colonic Hemorrhage
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Gastrointestinal disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • Number of events 1 • 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.
|
18.2%
2/11 • Number of events 2 • 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.
|
|
Nervous system disorders
Encephalopathy
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Gastrointestinal disorders
Entercolitis
|
0.00%
0/15 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.7%
1/15 • Number of events 1 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/15 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Hepatobiliary disorders
Hepatic Failure
|
13.3%
2/15 • Number of events 2 • 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.
|
0.00%
0/11 • 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.
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1 • 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.
|
18.2%
2/11 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Ileal Obstruction
|
13.3%
2/15 • Number of events 2 • 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.
|
0.00%
0/11 • 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.
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/15 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Mucositis Oral
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • Number of events 1 • 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.
|
18.2%
2/11 • Number of events 2 • 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.
|
|
Infections and infestations
Small Intestine Infection
|
0.00%
0/15 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Infections and infestations
Upper Respiratory Infection
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Infections and infestations
Urinary Tract Infection
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Infections and infestations
Wound Infection
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
Other adverse events
| Measure |
Arm I (MMF-15, Sargramostim)
n=15 participants at risk
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)
n=11 participants at risk
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.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
60.0%
9/15 • Number of events 12 • 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.
|
36.4%
4/11 • Number of events 7 • 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.
|
|
Blood and lymphatic system disorders
neutropenia
|
46.7%
7/15 • Number of events 9 • 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.
|
45.5%
5/11 • Number of events 5 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
53.3%
8/15 • Number of events 12 • 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.
|
45.5%
5/11 • Number of events 8 • 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.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
5/15 • Number of events 5 • 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.
|
45.5%
5/11 • Number of events 6 • 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.
|
|
Investigations
CD4 Lymphocytes Decreased
|
6.7%
1/15 • Number of events 1 • 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.
|
18.2%
2/11 • Number of events 2 • 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.
|
|
Infections and infestations
White Blood Cell Count Decreased
|
6.7%
1/15 • Number of events 1 • 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.
|
27.3%
3/11 • Number of events 4 • 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.
|
|
Cardiac disorders
Atrial Fibrilation
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
13.3%
2/15 • Number of events 2 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • Number of events 1 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • Number of events 1 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Hepatobiliary disorders
Cholecystitis
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Infections and infestations
Catheter Related Infection
|
6.7%
1/15 • Number of events 3 • 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.
|
0.00%
0/11 • 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.
|
|
Infections and infestations
Urinary Tract Infection
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 2 • 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.
|
18.2%
2/11 • Number of events 2 • 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.
|
|
Cardiac disorders
Ventricular Tachycardia
|
6.7%
1/15 • Number of events 1 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Investigations
Lymphocyte Count Decreased
|
40.0%
6/15 • Number of events 6 • 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.
|
36.4%
4/11 • Number of events 8 • 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.
|
Additional Information
Dr. Amir Toor, Principal Investigator
Virginia Commonwealth University Massey Cancer Center
Phone: 804 828 5116
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place