Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients
Status:
Recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
This is a global, Phase 3b, multicenter, open-label, single-arm study to evaluate the safety
and efficacy of acalabrutinib 100 mg bid in approximately 600 participants with chronic
lymphocytic leukemia (CLL). Participants will be enrolled into 3 cohorts: treatment-naive
(TN), relapsed/refractory (R/R), and prior Bruton tyrosine kinase inhibitor (BTKi) therapy.
Participants will remain on study treatment until completion of 48 cycles (28 days per
cycle), disease progression, toxicity requiring discontinuation, withdrawal of consent, lost
to follow-up, death, or study termination by the sponsor whichever occurs first. The duration
of the study will be approximately 72 months from the first participant enrolled. This
duration includes an estimated 24-month recruitment time and an assumed 48 cycles of study
treatment (28 days per cycle); additional study time will be accrued during the follow-up
period for those participants remaining on study treatment after completion of 48 cycles (the
amount of time will vary by participant)