Conditions: Lymphocytic Leukemia, Chronic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 43
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5 years.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: fludarabine intervention 3: cyclophosphamide
Intervention descriptions: intervention 1: Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8 intervention 2: Every 4 weeks, 6 cycles intervention 3: Every 4 weeks, 3 cycles

Protocol document: