Conditions: Chronic Lymphocytic Leukemia (CLL)
Keywords: CLL TRU-016 chronic lymphocytic leukemia relapsed CLL bendamustine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 79
Healthy volunteers: no

Brief summary:
The objective of the first part of the study is to determine a safe dose of TRU-016 that can be used in combination with bendamustine in patients with relapsed CLL. The objectives of the second part of the study are to compare the safety and efficacy of TRU-016 in combination with bendamustine to bendamustine alone in patients with relapsed CLL.

Detailed description:
This study consisted of two parts. The initial dose escalation stage was a Phase 1b study evaluating the safety and tolerability of two doses of TRU-016 administered in combination with bendamustine to patients with relapsed chronic lymphocytic leukemia (CLL). In the randomized Phase 2 stage of the study, the efficacy and safety of the selected dose of 20 mg/kg TRU-016 combined with bendamustine was compared to bendamustine alone. The pharmacokinetics and pharmacodynamics of TRU-016 and the development of antibodies to TRU-016 were evaluated in both phases of the study.

Arms:
arm 1: TRU-016 (15 mg/kg) and bendamustine (70 mg/m2), n = 6 patients arm 2: TRU-016 (20 mg/kg) and bendamustine (70 mg/m2), n = 6 patients arm 3: TRU-016 (20 mg/kg) and bendamustine (70 mg/m2), n = 32 patients arm 4: Bendamustine (70 mg/m2), n = 33 patients

Interventions: intervention 1: TRU-016 and bendamustine intervention 2: Bendamustine intervention 3: 15 mg/kg TRU-016 and bendamustine intervention 4: 20 mg/kg TRU-016 and bendamustine
Intervention descriptions: intervention 1: TRU-016 at 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 intervention 2: Bendamustine at 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles intervention 3: TRU-016 at 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 intervention 4: TRU-016 at 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

Protocol document: