Conditions: Chronic Lymphocytic Leukemia (CLL)
Keywords: Chronic lymphocytic leukemia; leukemia; B-Cell malignancy; anti-CD19; monoclonal antibody; CLL; Refractory; Relapse; Non-Hodgkin's Lymphoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 183
Healthy volunteers: no

Brief summary:
The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to rituximab in the same population.

Detailed description:

Arms:
arm 1: Rituximab was administered by IV infusion as 375 mg/m\^2 on Day 2 of Cycle 1 and then 500 mg/m\^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle. arm 2: MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle. arm 3: MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.

Interventions: intervention 1: Rituximab intervention 2: Bendamustine intervention 3: MEDI-551
Intervention descriptions: intervention 1: Rituximab was administered by IV infusion as a dose of 375 mg/m\^2 on Day 2 of Cycle 1 and then at 500 mg/m\^2 on Day 1 of up to 5 subsequent 28-day cycles intervention 2: Bendamustine was administered by IV infusion as a dose of 70 mg/m\^2 on Day 1 and Day 2 of each 5 subsequent 28-day cycle. intervention 3: MEDI-551 was administered at 2 mg/kg or 4 mg/kg by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycles.

Protocol document: