A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia
A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia
This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.
Inclusion Criteria:
Men and women ≥ 18 years of age.
ECOG performance status of 0 to 2.
Diagnosis of CLL.
Must have ≥ 1 of the following high-risk prognostic factors:
Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment
Must have received ≥ 1 prior therapies for CLL.
Meet the following laboratory parameters:
Exclusion Criteria:
Northwest WA, Wisconsin 20007, United States
Waratah NSW, 2298, Australia
Indgang 27B, DK-4000, Denmark
Petah Tikvah, 49102, Israel
Zutphens, 7207 AE, Netherlands
Instabul, 34365, Turkey (Türkiye)
Greater London, E1 2AD, United Kingdom
Surrey, SM2 5PT, United Kingdom