Trial Outcomes & Findings for Fludarabine, Bendamustine, and Rituximab (FBR) for Relapsed Chronic Lymphocytic Leukemia (CLL) (NCT NCT01096992)
NCT ID: NCT01096992
Last Updated: 2019-09-25
Results Overview
MTD defined as highest dose level in which 6 participants have been treated with \</= to 1 patient experiencing dose limiting toxicity (DLT). MTD exceeded if 2 or more of 6 patients experience grade 3 or higher, non-hematologic, non-infusion related toxicity a major organ system. DLT defined as treatment-related, grade \>/= 3 non-hematologic toxicity. Hematologic toxicity grade \>/= 3 that lasts longer than 42 days considered a DLT. Hematologic toxicity graded according to the 2008 IWCLL criteria for grading. Tumor lysis not considered a DLT.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
51 participants
Primary outcome timeframe
After 4 week cycle
Results posted on
2019-09-25
Participant Flow
Recruitment Period: 4/2010 to 012/2013
Participant milestones
| Measure |
Phase 1 20 mg/m^2
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 20 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 30 mg/m^2
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 30 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 40 mg/m^2
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 40 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 50 mg/m^2
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 50 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 2
Bendamustine 30 mg/m\^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab
Phase 2: 30 mg/m\^2 by vein (fixed) on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
6
|
6
|
30
|
|
Overall Study
COMPLETED
|
6
|
3
|
6
|
6
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fludarabine, Bendamustine, and Rituximab (FBR) for Relapsed Chronic Lymphocytic Leukemia (CLL)
Baseline characteristics by cohort
| Measure |
Phase 1 20 mg/m^2
n=6 Participants
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 20 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 30 mg/m^2
n=3 Participants
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 30 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 40 mg/m^2
n=6 Participants
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 40 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 50 mg/m^2
n=6 Participants
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 50 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 2
n=30 Participants
Bendamustine 30 mg/m\^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab
Phase 2: 30 mg/m\^2 by vein (fixed) on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
35 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
16 Participants
n=30 Participants
|
|
Age, Continuous
|
63 years
n=99 Participants
|
64 years
n=107 Participants
|
63 years
n=206 Participants
|
62 years
n=7 Participants
|
61 years
n=31 Participants
|
62 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
38 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
46 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
51 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: After 4 week cyclePopulation: Maximum Tolerated Dose (MTD) was not established as an objective for the phase II portion of this study and was not collected.
MTD defined as highest dose level in which 6 participants have been treated with \</= to 1 patient experiencing dose limiting toxicity (DLT). MTD exceeded if 2 or more of 6 patients experience grade 3 or higher, non-hematologic, non-infusion related toxicity a major organ system. DLT defined as treatment-related, grade \>/= 3 non-hematologic toxicity. Hematologic toxicity grade \>/= 3 that lasts longer than 42 days considered a DLT. Hematologic toxicity graded according to the 2008 IWCLL criteria for grading. Tumor lysis not considered a DLT.
Outcome measures
| Measure |
Phase 1
n=21 Participants
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: Starting Dose of 20 mg/m2 IV on Days 1,2,3 (after fludarabine)
Phase 2: 30 mg/m2 by vein (fixed) on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m2 IV, Day 1
|
Phase 1 30 mg/m^2
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 30 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 40 mg/m^2
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 40 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 50 mg/m^2
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 50 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 2
Bendamustine 30 mg/m\^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab
Phase 2: 30 mg/m\^2 by vein (fixed) on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)
|
30 mg/m^2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Overall response assessed 2 months after 6th or last course if participants not able to receive all 6 intended courses of treatment.Population: Two participants in the phase II portion of the study were not evaluable for response due to loss to follow-up.
Overall Response is Complete response (CR) + Partial response (PR). Overall response evaluated by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 for complete or partial response and progressive disease. Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; positive or negative minimal residual disease (MRD); Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts;
Outcome measures
| Measure |
Phase 1
n=6 Participants
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: Starting Dose of 20 mg/m2 IV on Days 1,2,3 (after fludarabine)
Phase 2: 30 mg/m2 by vein (fixed) on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m2 IV, Day 1
|
Phase 1 30 mg/m^2
n=3 Participants
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 30 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 40 mg/m^2
n=6 Participants
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 40 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 50 mg/m^2
n=6 Participants
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 50 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 2
n=28 Participants
Bendamustine 30 mg/m\^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab
Phase 2: 30 mg/m\^2 by vein (fixed) on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
|---|---|---|---|---|---|
|
Overall Response Rate of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)
|
5 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
17 Participants
|
Adverse Events
Phase 1 20 mg/m^2
Serious events: 4 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1 30 mg/m^2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 40 mg/m^2
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1 50 mg/m^2
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2
Serious events: 16 serious events
Other events: 30 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1 20 mg/m^2
n=6 participants at risk
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 20 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 30 mg/m^2
n=3 participants at risk
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 30 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 40 mg/m^2
n=6 participants at risk
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 40 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 50 mg/m^2
n=6 participants at risk
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 50 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 2
n=30 participants at risk
Bendamustine 30 mg/m\^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab
Phase 2: 30 mg/m\^2 by vein (fixed) on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
|---|---|---|---|---|---|
|
General disorders
Amloidosis
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
3.3%
1/30 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
3.3%
1/30 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
3.3%
1/30 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Gastrointestinal disorders
Dehydration
|
33.3%
2/6 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
6.7%
2/30 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Investigations
Drug Rash
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
3.3%
1/30 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
General disorders
Fainting
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
3.3%
1/30 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
General disorders
Fall
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
3.3%
1/30 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
3.3%
1/30 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
3.3%
1/30 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Infections and infestations
Infection
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
3.3%
1/30 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
50.0%
3/6 • Number of events 4 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
6.7%
2/30 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
3.3%
1/30 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Infections and infestations
Neutropenic Fever
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
33.3%
2/6 • Number of events 4 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
20.0%
6/30 • Number of events 7 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
3.3%
1/30 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
10.0%
3/30 • Number of events 3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
3.3%
1/30 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Investigations
Tumor Flare
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
3.3%
1/30 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Metabolism and nutrition disorders
Tumor Lysis
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
33.3%
2/6 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
10.0%
3/30 • Number of events 3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Gastrointestinal disorders
Acites
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Investigations
Allergic Reaction Investigational Product
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Infections and infestations
Bladder Infection
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
General disorders
Chills
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Blood and lymphatic system disorders
Elevated BUN
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
General disorders
Fever
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Musculoskeletal and connective tissue disorders
Gout
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
General disorders
Growth Neck
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Blood and lymphatic system disorders
Hemorrhage Bladder
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Blood and lymphatic system disorders
Subdural Hematoma
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
Other adverse events
| Measure |
Phase 1 20 mg/m^2
n=6 participants at risk
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 20 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 30 mg/m^2
n=3 participants at risk
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 30 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 40 mg/m^2
n=6 participants at risk
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 40 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 1 50 mg/m^2
n=6 participants at risk
Bendamustine, Fludarabine + Rituximab
Bendamustine: Phase 1: 50 mg/m\^2 IV on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
Phase 2
n=30 participants at risk
Bendamustine 30 mg/m\^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab
Phase 2: 30 mg/m\^2 by vein (fixed) on Days 1,2,3 (after fludarabine)
Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3
Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
10.0%
3/30 • Number of events 3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
66.7%
2/3 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
66.7%
4/6 • Number of events 4 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
50.0%
3/6 • Number of events 3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
76.7%
23/30 • Number of events 33 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
33.3%
1/3 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
33.3%
2/6 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
50.0%
3/6 • Number of events 3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
100.0%
30/30 • Number of events 30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
33.3%
2/6 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
100.0%
3/3 • Number of events 3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
33.3%
2/6 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
100.0%
30/30 • Number of events 30 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 4 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
100.0%
3/3 • Number of events 3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
50.0%
3/6 • Number of events 3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
33.3%
2/6 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
60.0%
18/30 • Number of events 18 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
50.0%
15/30 • Number of events 32 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
50.0%
3/6 • Number of events 3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
6.7%
2/30 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
23.3%
7/30 • Number of events 7 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
66.7%
4/6 • Number of events 4 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
66.7%
4/6 • Number of events 4 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
33.3%
10/30 • Number of events 17 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
General disorders
Edema
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
6.7%
2/30 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Gastrointestinal disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
33.3%
1/3 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
50.0%
3/6 • Number of events 3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
10.0%
3/30 • Number of events 3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Metabolism and nutrition disorders
Tumor Lysis
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
16.7%
1/6 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
6.7%
2/30 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
6.7%
2/30 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
0.00%
0/6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
13.3%
4/30 • Number of events 4 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
Additional Information
William Wierda, MD./Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-745-0428
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place