A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
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.