Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients

Study Summary

This is a global, Phase IIIb, multicenter, open-label, single-arm study to evaluate the safety and efficacy of acalabrutinib 100 mg twice daily (bid) in approximately 540 participants with chronic lymphocytic leukemia (CLL). Participants will be enrolled into 3 following cohorts: treatment-naive (TN), relapsed/refractory (R/R), and prior ibrutinib therapy. For this study, participants in the UK will be enrolled ONLY into the R/R cohort or the prior ibrutinib cohort. Participants in the US will be enrolled ONLY into the TN or R/R cohort. Participants will remain on study intervention until completion of 48 cycles (28 days per cycle), or until study intervention discontinuation due to, for example disease progression, or toxicity, withdrawal of consent, loss 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 intervention (28 days per cycle); additional study time will be accrued during the Disease Follow up period for those participants remaining on study intervention after completion of 48 cycles prior to the final data cutoff (DCO) (the amount of time will vary by participant).

Primary Outcome

The safety and tolerability of acalabrutinib monotherapy were evaluated in participants with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia. Treatment-emergent AEs (TEAEs) were defined as AEs that started after first dose of acalabrutinib or which started prior to first dose of acalabrutinib but worsened following first dose of acalabrutinib, and where the start date of worsening was also no later than 30 days after the date of last dose of acalabrutinib or the first date s

Conditions Studied

Interventions

• DRUG Acalabrutinib

Study Locations (20)