STop and Restart Acalabrutinib In fRail Patients With Previously Untreated Chronic Lymphocytic Leukemia
Status:
Not yet recruiting
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
Summary
The irreversible Bruton's Tyrosine Kinase (BTK) inhibitor acalabrutinib (ACA) has potent
clinical activity as a single agent in patients with treatment naive and Relapsed/Refractory
Chronic Lymphocytic Leukemia (CLL).
However, a growing body of concerns is raising regarding the unlimited administration of
targeted therapy as BTKi. First, long-term treatments expose the patients to increased risk
of specific adverse events (infections, bleeding events or cardiovascular problems). Second,
continuous administration might also increase the risk of clonal evolution and therapeutic
resistance resulting from genetic alterations such as BTK or PLCG2 mutations. Discontinuation
of therapy after a fixed period is expected to prevent these events.
Rapid and deep responses yielded by ACA in elderly patients pave the way of investigating a
limited 18-months period schedule. This study aims to investigate the 1-year PFS upon ACA
discontinuation and efficacy of restarting ACA upon symptomatic relapse.