Trial Outcomes & Findings for Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia (NCT NCT01188681)

Last Updated: 2021-06-10

Results Overview

Patients had full clinical response assessment monthly during treatment, at the end of treatment (EOT) visit, 30 and 60 days after the EOT visit, and subsequently every 3 months until the earliest of progression of CLL, death, initiation of new therapy, withdrawal from the study, or completion of 18 months of follow-up evaluations. Clinical response assessment included physical examination with measurement of spleen, liver, and lymph nodes, disease-related symptoms, and laboratory measurements, specifically complete blood count (CBC) with differential.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

79 participants

Primary outcome timeframe

1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years

Results posted on

2021-06-10

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1 15 mg/kg TRU-016 (15 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles	Phase 1 20 mg/kg TRU-016 (20 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles	Phase 2 TRU-016 and Bendamustine Patients in the combination arm received otlertuzumab (20 mg/kg) weekly by IV infusion for two 28-day cycles then every 14 days for four 28-day cycles. In both arms, bendamustine (70 mg/m2) was administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.	Phase 2 Bendamustine Patients in the bendamustine arm received bendamustine (70 mg/m2) administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.
Overall Study STARTED	6	6	33	34
Overall Study COMPLETED	6	6	32	33
Overall Study NOT COMPLETED	0	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 15 mg/kg TRU-016 (15 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles	Phase 1 20 mg/kg TRU-016 (20 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles	Phase 2 TRU-016 and Bendamustine Patients in the combination arm received otlertuzumab (20 mg/kg) weekly by IV infusion for two 28-day cycles then every 14 days for four 28-day cycles. In both arms, bendamustine (70 mg/m2) was administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.	Phase 2 Bendamustine Patients in the bendamustine arm received bendamustine (70 mg/m2) administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.
Overall Study bladder cancer	0	0	1	0
Overall Study Withdrawal by Subject	0	0	0	1

Baseline Characteristics

Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1: 15 mg/kg TRU-016 n=6 Participants TRU-016 (15 mg/kg) and bendamustine (70 mg/m2) TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles	Phase 1: 20 mg/kg TRU-016 n=6 Participants TRU-016 (20 mg/kg) and bendamustine (70 mg/m2) TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles	Phase 2: TRU-016 and Bendamustine n=32 Participants TRU-016 (20 mg/kg) and bendamustine (70 mg/m2) TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles	Phase 2: Bendamustine n=33 Participants Bendamustine alone (70 mg/m2) Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles	Total n=77 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	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants	21 Participants n=4 Participants	41 Participants n=21 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants	12 Participants n=4 Participants	36 Participants n=21 Participants
Age, Continuous	66.3 years STANDARD_DEVIATION 5.8 • n=5 Participants	67.7 years STANDARD_DEVIATION 8.9 • n=7 Participants	64.1 years STANDARD_DEVIATION 9.4 • n=5 Participants	62.2 years STANDARD_DEVIATION 8.1 • n=4 Participants	62.3 years STANDARD_DEVIATION 8.4 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants	8 Participants n=4 Participants	24 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	20 Participants n=5 Participants	25 Participants n=4 Participants	53 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	32 Participants n=5 Participants	33 Participants n=4 Participants	77 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 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	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 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	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	30 Participants n=5 Participants	32 Participants n=4 Participants	72 Participants n=21 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	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: 1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years

Population: Treated patients

Outcome measures

Outcome measures
Measure	Phase 1 15 mg/kg TRU-016 n=6 Participants 15 mg/kg TRU-016 + 70 mg/m2 bendamustine (n=6) dose group	Phase 1 20 mg/kg TRU-016 n=6 Participants 20 mg/kg TRU-016 + 70 mg/m2 bendamustine (n=6) dose group	TRU-016 and Bendamustine n=32 Participants TRU-016 (n = 32 patients), 20 mg/kg and bendamustine (70 mg/m2) TRU-016 and bendamustine: TRU-016 (n = 33 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles	Bendamustine n=33 Participants Bendamustine alone (n = 33 patients) (70 mg/m2) Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria	66.7 percentage of patients	83.3 percentage of patients	68.8 percentage of patients	39.4 percentage of patients

SECONDARY outcome

Timeframe: 1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years

Population: Safety data for all patients who received any study drug and efficacy data for randomized patients who received some study treatment and have some post baseline data are presented here.

Overall response rate per National Cancer Institute (NCI) Working group criteria.

Outcome measures

Outcome measures
Measure	Phase 1 15 mg/kg TRU-016 n=32 Participants 15 mg/kg TRU-016 + 70 mg/m2 bendamustine (n=6) dose group	Phase 1 20 mg/kg TRU-016 n=33 Participants 20 mg/kg TRU-016 + 70 mg/m2 bendamustine (n=6) dose group	TRU-016 and Bendamustine n=6 Participants TRU-016 (n = 32 patients), 20 mg/kg and bendamustine (70 mg/m2) TRU-016 and bendamustine: TRU-016 (n = 33 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles	Bendamustine n=6 Participants Bendamustine alone (n = 33 patients) (70 mg/m2) Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
Response Per NCI Criteria	81.3 percentage of patients	66.7 percentage of patients	66.7 percentage of patients	100 percentage of patients

Adverse Events

Phase 1: 15 mg/kg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Phase 1: 20 mg/kg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Phase 2: TRU-016 and Bendamustine

Serious events: 10 serious events

Other events: 24 other events

Deaths: 0 deaths

Phase 2:Bendamustine

Serious events: 15 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Scott C. Stromatt

Emergent BioSolutions

Phone: 206-859-6675

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Phase 1: 15 mg/kg n=6 participants at risk TRU-016 (15 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles	Phase 1: 20 mg/kg n=6 participants at risk TRU-016 (20 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles	Phase 2: TRU-016 and Bendamustine n=32 participants at risk TRU-016 (20 mg/kg) and bendamustine (70 mg/m2) TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles	Phase 2:Bendamustine n=33 participants at risk Bendamustine alone (70 mg/m2) Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
Blood and lymphatic system disorders Febrile neutropenia	33.3% 2/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	16.7% 1/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.1% 1/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.0% 1/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Blood and lymphatic system disorders Aplasia pure red cell	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.0% 1/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	16.7% 1/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.0% 1/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.0% 1/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Cardiac disorders Cardiac failure acute	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.0% 1/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.0% 1/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.1% 1/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Gastrointestinal disorders Gastritis	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.1% 1/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Gastrointestinal disorders Nausea	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.0% 1/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.0% 1/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
General disorders Pyrexia	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	9.4% 3/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	9.1% 3/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
General disorders Chills	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.0% 1/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Infections and infestations Pneumonia	16.7% 1/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	9.4% 3/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	12.1% 4/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Infections and infestations Bronchitis	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	9.1% 3/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Infections and infestations Bacteraemia	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.1% 1/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Infections and infestations Bronchopneumonia	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.0% 1/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Infections and infestations Cellulitis	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.0% 1/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Infections and infestations Respiratory tract infection	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.0% 1/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Infections and infestations Thrombophlebitis septic	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.1% 1/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.1% 1/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Investigations Blood creatinine increased	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.1% 1/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Metabolism and nutrition disorders Gout	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.1% 1/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.1% 1/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Renal and urinary disorders Renal failure acute	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	3.0% 1/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Infections and infestations Urinary tract infection	16.7% 1/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Musculoskeletal and connective tissue disorders Myopathy	16.7% 1/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 1/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/6 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/32 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.	0.00% 0/33 • Adverse event information was collected during the clinical trial from the time consent was given through 30 days post last drug infusion.