Trial Outcomes & Findings for Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL) (NCT NCT01010568)

NCT ID: NCT01010568

Last Updated: 2015-12-15

Results Overview

40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2015-12-15

Participant Flow

Participant milestones

Measure	Ofatumumab and Bendamustine Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia
Overall Study STARTED	10
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)

Baseline characteristics by cohort

Measure	Ofatumumab and Bendamustine n=10 Participants Ofatumumab and Bendamustine Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia

Outcome measures

Measure	Ofatumumab and Bendamustine n=10 Participants Ofatumumab and Bendamustine Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles
Overall Response Rate	4 participants

SECONDARY outcome

Timeframe: 6 months

NCI IWG response criteria

Outcome measures

Measure	Ofatumumab and Bendamustine n=10 Participants Ofatumumab and Bendamustine Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles
Complete Response Rate	2 participants

SECONDARY outcome

Timeframe: 2 years

Kaplan Meyer PFS

Outcome measures

Measure	Ofatumumab and Bendamustine n=10 Participants Ofatumumab and Bendamustine Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles
Median PFS	8.1 months Interval 3.2 to 22.6

Adverse Events

Ofatumumab and Bendamustine

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ofatumumab and Bendamustine n=10 participants at risk Ofatumumab and Bendamustine Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles
General disorders Fatigue	30.0% 3/10 • Number of events 3 • 1 year
Injury, poisoning and procedural complications Infusion related reaction	10.0% 1/10 • Number of events 1 • 1 year
Nervous system disorders Ataxia	10.0% 1/10 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Muscle Weakness	20.0% 2/10 • Number of events 2 • 1 year
Blood and lymphatic system disorders Neutropenia	20.0% 2/10 • Number of events 2 • 1 year
Infections and infestations Infection	20.0% 2/10 • Number of events 2 • 1 year

Other adverse events

Measure	Ofatumumab and Bendamustine n=10 participants at risk Ofatumumab and Bendamustine Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles
Blood and lymphatic system disorders Neutropenia	80.0% 8/10 • Number of events 8 • 1 year
General disorders fatigue	60.0% 6/10 • Number of events 6 • 1 year
Infections and infestations Infection	60.0% 6/10 • Number of events 6 • 1 year
Gastrointestinal disorders Diarrhea	20.0% 2/10 • Number of events 2 • 1 year
Musculoskeletal and connective tissue disorders Muscle Weakness	10.0% 1/10 • Number of events 1 • 1 year
Hepatobiliary disorders Hyperbilirubinemia	30.0% 3/10 • Number of events 3 • 1 year
Injury, poisoning and procedural complications Allergy/infusion reaction	50.0% 5/10 • Number of events 5 • 1 year
General disorders Fever	50.0% 5/10 • Number of events 5 • 1 year
Skin and subcutaneous tissue disorders Rash	50.0% 5/10 • Number of events 5 • 1 year
Gastrointestinal disorders Nausea	40.0% 4/10 • Number of events 4 • 1 year
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 2/10 • Number of events 2 • 1 year
Respiratory, thoracic and mediastinal disorders Pneumonitis	10.0% 1/10 • Number of events 1 • 1 year
Blood and lymphatic system disorders Anemia	80.0% 8/10 • Number of events 8 • 1 year
Blood and lymphatic system disorders Thrombocytopenia	10.0% 1/10 • Number of events 1 • 1 year
Vascular disorders Phlebitis	10.0% 1/10 • Number of events 1 • 1 year

Additional Information

Bruce D. Cheson

Georgetown University Hospital

Phone: 202-444-1212

Email: bdc4@georgetown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place