Clinical Trials Search
Clinical Trial 18539
Cancer Type: Malignant Hematology
Interventions:748645 (Ibrutinib); ACP-196 (Acalabrutinib); Ibrutinib (Imbruvica); PCI-32765 (Ibrutinib)
Study Type: Treatment
Phase of Study: Phase III
A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase 3 Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia
The purpose of this study is to determine if an experimental drug: ACP-196 is safe and effective in the treatment of Chronic Lymphocytic Leukemia (CLL).
To assess whether ACP-196 is non-inferior to ibrutinib with respect to progression-free survival (PFS) based on independent review committee (IRC) assessment in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL) with high-risk prognostic markers. The IRC will use the International Workshop on Chronic Lymphocytic Leukemia Criteria (IWCLL, Hallek 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson 2012)¿hereafter referred to as IWCLL 2008 criteria.