Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 86
Healthy volunteers: no

Brief summary:
This single arm study will assess the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide, followed by rituximab maintenance therapy, as first line treatment of participants with CLL.

Detailed description:

Arms:
arm 1: Participants will receive 6 cycles (cycle length = 28 days) of treatment with rituximab (375 milligrams per square meter \[mg/m\^2\] as intravenous \[IV\] infusion on Day 0 of Cycle 1 and 500 mg/m\^2 as IV infusion on Day 1 of Cycles 2-6); fludarabine (25 mg/m\^2 on Days 1-3) and cyclophosphamide (250 mg/m\^2 on Days 1-3). Participants with a partial or complete response and appropriate neutrophil conditions will receive maintenance treatment with rituximab (375 mg/m\^2 as IV infusion every 2 months) from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6.

Interventions: intervention 1: Cyclophosphamide intervention 2: Fludarabine intervention 3: Rituximab
Intervention descriptions: intervention 1: Cyclophosphamide 250 mg/m\^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles. intervention 2: Fludarabine 25 mg/m\^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles. intervention 3: Rituximab 375 mg/m\^2 as IV infusion will be administered on Day 0 of Cycle 1; 500 mg/m\^2 as IV infusion will be administered on Day 1 of Cycle 2-6; and 375 mg/m\^2 as IV infusion every 2 months from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6.

Protocol document: