Phase 2 Study of Alternating FCRBR and Ibrutinib Treatment in Adults With Untreated Chronic Lymphocytic Leukemia

What this Trial Is About

Researchers are evaluating the response rate and safety of alternating treatment with FCRBR and ibrutinib in patients with chronic lymphocytic leukemia CLL who have not received prior therapy. This prospective multicenter phase 2 study focuses on treatment-naive CLL patients to understand how this combination may affect disease control and patient outcomes. Treatment involves an induction phase where patients under 65 without significant health issues receive 1 or 2 courses of FCR chemotherapy, alternating with 3 months of oral ibrutinib, repeated in cycles. Patients 65 or older, or those under 65 with other health conditions, receive BR chemotherapy similarly alternating with ibrutinib. After induction, maintenance therapy with either ibrutinib or thalidomide is recommended but not mandatory for patients depending on their minimal residual disease status. Participants will be assessed for complete response rate three months after induction, along with other outcomes such as overall response rate, survival over five years, progression-free survival, minimal residual disease negativity, duration of response, and treatment-related side effects. Monitoring includes clinical evaluations and safety assessments throughout treatment and follow-up, lasting until the studys planned completion in 2027.

A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With CLL