Trial Outcomes & Findings for Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) (NCT NCT02464657)
NCT ID: NCT02464657
Last Updated: 2021-10-07
Results Overview
MTD is highest dose level in which \<2 patients of 6 develop first cycle dose-limiting toxicity (DLT).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
44 participants
Primary outcome timeframe
28 days
Results posted on
2021-10-07
Participant Flow
Recruitment Period: July 2015 - June 2018
Participant milestones
| Measure |
Ph 1 - Nivolumab (1mg) + Idarubicin + Cytarabine
Phase I starting dose of Nivolumab 1 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
Ph 1 - Nivolumab (3mg) + Idarubicin + Cytarabine
Phase I starting dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
Ph 2 - Nivolumab + Idarubicin + Cytarabine
Phase II dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
39
|
|
Overall Study
COMPLETED
|
3
|
2
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Ph 1 - Nivolumab (1mg) + Idarubicin + Cytarabine
n=3 Participants
Phase I dose of Nivolumab 1 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
Ph 1 - Nivolumab (3mg) + Idarubicin + Cytarabine
n=2 Participants
Phase I dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
|
Ph 2 - Nivolumab + Idarubicin + Cytarabine
n=39 Participants
Phase II dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
Total
n=44 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
51 years
n=5 Participants
|
63 years
n=7 Participants
|
54 years
n=5 Participants
|
54 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
39 participants
n=5 Participants
|
44 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 daysMTD is highest dose level in which \<2 patients of 6 develop first cycle dose-limiting toxicity (DLT).
Outcome measures
| Measure |
Ph 1 - Nivolumab (1mg) + Idarubicin + Cytarabine
n=3 Participants
Phase I dose of Nivolumab 1 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
Ph 1 - Nivolumab (3mg) + Idarubicin + Cytarabine
n=2 Participants
Phase I dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
|---|---|---|
|
Maximum Tolerated Dose (MTD) of Nivolumab
|
NA mg/kg
MTD was determined in the next dose level for the phase I portion of the study.
|
3 mg/kg
|
SECONDARY outcome
Timeframe: 56 daysEFS defined as time from the treatment start till treatment failure, relapse, or death whichever comes first. Event Free Survival will be presented by median EFS, which is the time point at which the cumulative survival drops below 50%. If there is no median survival (not reached), it means the cumulative survival was more than 50%.
Outcome measures
| Measure |
Ph 1 - Nivolumab (1mg) + Idarubicin + Cytarabine
n=39 Participants
Phase I dose of Nivolumab 1 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
Ph 1 - Nivolumab (3mg) + Idarubicin + Cytarabine
Phase I dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
|---|---|---|
|
Event-Free Survival (EFS)
|
NA Months
Interval 7.93 to
Event-Free Survival median was not reached.
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years and10 MonthsRelapse-free survival was defined as the time from treatment response to date of relapse or death, whichever occurred first.
Outcome measures
| Measure |
Ph 1 - Nivolumab (1mg) + Idarubicin + Cytarabine
n=39 Participants
Phase I dose of Nivolumab 1 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
Ph 1 - Nivolumab (3mg) + Idarubicin + Cytarabine
Phase I dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
|---|---|---|
|
Relapse Free Survival
|
18.54 Months
Interval 8.2 to 23.22
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years and 10 MonthsOverall survival was defined as the time from the start of treatment to death or date of last follow-up.
Outcome measures
| Measure |
Ph 1 - Nivolumab (1mg) + Idarubicin + Cytarabine
n=39 Participants
Phase I dose of Nivolumab 1 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
Ph 1 - Nivolumab (3mg) + Idarubicin + Cytarabine
Phase I dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
|---|---|---|
|
Overall Survival
|
18.54 Months
Interval 10.81 to 28.81
|
—
|
Adverse Events
Ph 1 Nivolumab (1mg) + Idarubicin + Cytarabine
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Ph 1 Nivolumab (3mg) + Idarubicin + Cytarabine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Ph 2 Nivolumab (3mg) + Idarubicin + Cytarabine
Serious events: 32 serious events
Other events: 32 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Ph 1 Nivolumab (1mg) + Idarubicin + Cytarabine
n=3 participants at risk
Phase I dose of Nivolumab 1 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
Ph 1 Nivolumab (3mg) + Idarubicin + Cytarabine
n=2 participants at risk
Phase I dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
Ph 2 Nivolumab (3mg) + Idarubicin + Cytarabine
n=39 participants at risk
Phase II dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
71.8%
28/39 • Number of events 50 • Up to 2 years 10 months
|
|
General disorders
Abdominal Pain
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Blood and lymphatic system disorders
Blood and Lymphatic system disorder
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Hepatobiliary disorders
Cholecyctitis
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
7.7%
3/39 • Number of events 3 • Up to 2 years 10 months
|
|
General disorders
Fever
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
28.2%
11/39 • Number of events 12 • Up to 2 years 10 months
|
|
Gastrointestinal disorders
Ileocolitis/typhlitis
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
General disorders
Headache
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Hepatobiliary disorders
Elevated Liver Enzymes
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
12.8%
5/39 • Number of events 6 • Up to 2 years 10 months
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Infections and infestations
Lung Infection
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
15.4%
6/39 • Number of events 6 • Up to 2 years 10 months
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
General disorders
Neck Pain
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 3 • Up to 2 years 10 months
|
|
General disorders
Pelvic Pain
|
33.3%
1/3 • Number of events 1 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
0.00%
0/39 • Up to 2 years 10 months
|
|
Investigations
Thrombocytopenia
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Infections and infestations
Pneumonitis
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Reproductive system and breast disorders
Vatinal Hemorrhage
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral Pulmonary Nodules
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
Other adverse events
| Measure |
Ph 1 Nivolumab (1mg) + Idarubicin + Cytarabine
n=3 participants at risk
Phase I dose of Nivolumab 1 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
Ph 1 Nivolumab (3mg) + Idarubicin + Cytarabine
n=2 participants at risk
Phase I dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
Ph 2 Nivolumab (3mg) + Idarubicin + Cytarabine
n=39 participants at risk
Phase II dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.
Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
23.1%
9/39 • Number of events 10 • Up to 2 years 10 months
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
12.8%
5/39 • Number of events 5 • Up to 2 years 10 months
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
7.7%
3/39 • Number of events 3 • Up to 2 years 10 months
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Up to 2 years 10 months
|
100.0%
2/2 • Number of events 2 • Up to 2 years 10 months
|
38.5%
15/39 • Number of events 24 • Up to 2 years 10 months
|
|
Skin and subcutaneous tissue disorders
Erythmea
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
100.0%
3/3 • Number of events 5 • Up to 2 years 10 months
|
100.0%
2/2 • Number of events 6 • Up to 2 years 10 months
|
20.5%
8/39 • Number of events 12 • Up to 2 years 10 months
|
|
General disorders
Fever
|
0.00%
0/3 • Up to 2 years 10 months
|
50.0%
1/2 • Number of events 1 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 3 • Up to 2 years 10 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Up to 2 years 10 months
|
50.0%
1/2 • Number of events 1 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • Up to 2 years 10 months
|
50.0%
1/2 • Number of events 1 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Infections and infestations
Infection
|
33.3%
1/3 • Number of events 1 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
10.3%
4/39 • Number of events 5 • Up to 2 years 10 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
23.1%
9/39 • Number of events 11 • Up to 2 years 10 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
23.1%
9/39 • Number of events 14 • Up to 2 years 10 months
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 4 • Up to 2 years 10 months
|
|
General disorders
Oral Pain
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Investigations
Thrombocytopenia
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
17.9%
7/39 • Number of events 13 • Up to 2 years 10 months
|
|
Infections and infestations
Pneumonitis
|
0.00%
0/3 • Up to 2 years 10 months
|
50.0%
1/2 • Number of events 1 • Up to 2 years 10 months
|
2.6%
1/39 • Number of events 1 • Up to 2 years 10 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
23.1%
9/39 • Number of events 10 • Up to 2 years 10 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
5.1%
2/39 • Number of events 2 • Up to 2 years 10 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
20.5%
8/39 • Number of events 8 • Up to 2 years 10 months
|
|
Investigations
Leukopenia
|
0.00%
0/3 • Up to 2 years 10 months
|
0.00%
0/2 • Up to 2 years 10 months
|
20.5%
8/39 • Number of events 12 • Up to 2 years 10 months
|
Additional Information
Dr. Farhad Ravandi-Kashani, MD/Professor
The University of Texas MD Anderson Cancer Center
Phone: (713)745-0394
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place