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
Philip A. Thompson
The goal of this clinical research study is to learn if ACP-196 is able to control CLL and SLL as well as ibrutinib. The safety of ACP-196 will also be studied.
Treatment Location: N/A
Primary Objective: 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. Secondary Objectives: To evaluate the benefit:risk of ACP-196 versus ibrutinib in terms of: Grade 3 infections Richter's transformation (RT) Atrial fibrillation (AF) Overall survival (OS) Safety Objectives: Safety and tolerability including adverse events of interest and laboratory assessments Exploratory Objectives: IRC-assessed overall response rate (ORR) per IWCLL 2008 criteria Investigator-assessed PFS and ORR per IWCLL 2008 criteria Improvement and/or resolution of disease-related symptoms Improvement in incidence of diarrhea, major bleeding events, lymphocytosis, and secondary malignancy Patient-reported outcome (PRO) by various scales Medical resource utilization (MRU) Pharmacokinetic (PK) characteristics of ACP-196 in subjects with CLL to determine which, if any, covariates (eg, age, sex, body size, race) influence exposure to ACP-196 Identification of potential predictive biomarkers and mechanisms of disease resistance.
IRB Review and Approval Date: 06/23/2016
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
Philip A. Thompson
For general questions about clinical trials: