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

Summary

Participation Requirements

Description

This is a 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) (minimum of 300 participants), r...

This is a 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) (minimum of 300 participants), relapsed/refractory (R/R) (approximately 200 participants), and prior bruton tyrosine kinase inhibitor (BTKi) therapy (up to 70 to 100 participants). Assessment of response and progression will be conducted by the investigator in accordance with the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria. Overall response assessments will be based on evaluation of physical examinations, recording of symptoms, radiologic evaluations, and hematologic evaluations. Study treatment (acalabrutinib 100 mg bid) will be administered until disease progression, unacceptable toxicity, 48 cycles of study treatment, withdrawal of consent, loss to follow-up, death, or study termination by the sponsor, whichever comes first (each cycle is 28 days). In-clinic visits will occur every cycle for the first 6 cycles, and then every 3 cycles for the next 6 cycles. After 12 cycles "in-clinic visits" will occur every 6 cycles. Safety follow up visits will occur approximately 30 days from the last dose of study treatment. If a participant continues to derive benefit from treatment at the end of 48 cycles, they will continue to be provided with study treatment. This may include, but not be limited to, transition to a long-term extension trial, continuous supply in this trial (for eg in countries where regulatory approval is not obtained, or drug is not reimbursed) or switching to commercial drug as permitted by local regulations. Participants who remain in the trial after the completion of 48 cycles will be followed for disease progression, description of all subsequently administered anticancer therapies, and IWCLL indication for initiation of subsequent anticancer therapies q24w via standard practice until transition to regulatory approved off-study acalabrutinib, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor. Participants who switch to off-study acalabrutinib will be considered as having completed the study and therefore will not have any additional study assessments, including the disease follow-up period. 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).

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