A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
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The overall response rate (ORR) of ACP-196 (acalabrutinib) in subjects with relapsed/refractory CLL who are intolerant of ibrutinib therapy [ Time Frame: 36 cycles (each cycle is 28 days) up to 36 months ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Men and women ≥ 18 years of age.
Prior diagnosis of CLL
Must have received ≥ 1 prior therapy for CLL
Intolerant of ibrutinib
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
ECOG performance status of ≤ 2.
Ongoing AE attributed to ibrutinib therapy
Treatment with systemic anticancer therapy for CLL is prohibited between discontinuation of ibrutinib and enrollment on this trial.
Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199)
Prior malignancy (other than CLL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for ≥ 2 years.
Significant cardiovascular disease such as uncontrolled or symptomatic untreated arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or QTc > 480 msec at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.