Conditions: Lymphocytic Leukemia, Chronic
Allocation:  | Intervention model: PARALLEL
Enrollment: 240
Healthy volunteers: no

Brief summary:
This randomized, parallel-group, multi-center study will compare the pharmacokinetics and safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in combination with chemotherapy in previously untreated patients with chronic lymphocytic leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6 cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug is 24 weeks.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Cyclophosphamide intervention 2: Fludarabine intervention 3: rituximab [MabThera] intervention 4: rituximab [MabThera] intervention 5: rituximab [MabThera]
Intervention descriptions: intervention 1: Days 1-3 or Days 1-5 of cycles 1-6 intervention 2: Days 1-3 or Days 1-5 of cycles 1-6 intervention 3: One cycle of intravenous MabThera, followed by 5 cycles of subcutaneous MabThera intervention 4: After 4 cycles of intravenous MabThera without experiencing grade 3 or 4 infusion-related reactions. patients will receive 1 additional cycle of intravenous MabThera and 1 cycle of subcutaneous MabThera. intervention 5: 6 cycles of intravenous MabThera

Protocol document: