Conditions: Lymphocytic Leukemia, Chronic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 34
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.

Detailed description:

Arms:
arm 1: Participants will receive rituximab (375 milligrams per meter-squared \[mg/m\^2\] intravenously \[IV\]) on Cycle 1 Day 1, followed by fludarabine (25 mg/m\^2 once daily IV) and cyclophosphamide (250 mg/m\^2 once daily IV) for Days 2 to 4 of Cycle 1. Then rituximab (500 mg/m\^2 IV) will be administered on Day 1 of Cycles 2 to 6, followed by IV fludarabine (25 mg/m\^2 once daily IV) and cyclophosphamide (250 mg/m\^2 once daily IV) on Days 1 to 3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length, and the overall duration of treatment will be approximately 6 months.

Interventions: intervention 1: Cyclophosphamide intervention 2: Fludarabine intervention 3: Rituximab
Intervention descriptions: intervention 1: Cyclophosphamide will be administered IV at 250 mg/m\^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length. intervention 2: Fludarabine will be administered IV at 25 mg/m\^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length. intervention 3: Rituximab will be administered IV at 375 mg/m\^2 on Day 1 of Cycle 1 and then at 500 mg/m\^2 on Day 1 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

Protocol document: