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A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects With Chronic Lymphocytic Leukemia.
Eligible participants will be enrolled into one of three cohorts. In the treatment-naive (TN) cohort, a minimum of 300 participants with treatment-naive chronic lymphocytic leukemia will be enrolled. In the relapsed/refractory (R/R) cohort, approximately 200 participants with relapsed/refractory chronic lymphocytic leukemia will be enrolled. In the prior Bruton tyrosine kinase inhibitor (BTKi) therapy cohort, up to 70 to 100 participants with Prior BTKi therapy will be enrolled. Across the three cohorts, Acalabrutinib will be administered to participants as one 100 mg capsule, taken orally, twice daily with approximately 240 mL of water.