Official Title
A Phase 3b, Multicentre, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects With Chronic Lymphocytic Leukemia.
Summary:
This is a global, Phase 3b, multicentre, 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)
Trial Description
Primary Outcome:
- Number of participants with adverse events
Secondary Outcome:
- Objective response rate (ORR)
- Duration of response (DOR)
- Progression-free survival (PFS)
This is a Phase 3b, multicentre, 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).
View this trial on ClinicalTrials.gov
