A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

Inclusion Criteria:

1. Men and women ≥ 18 years of age.

2. Prior diagnosis of CLL

3. Must have received ≥ 1 prior therapy for CLL

4. Intolerant of ibrutinib

5. Willing and able to participate in all required evaluations and procedures in this
study protocol including swallowing capsules without difficulty.

6. ECOG performance status of ≤ 2.

Exclusion Criteria:

1. Ongoing AE attributed to ibrutinib therapy

2. Treatment with systemic anticancer therapy for CLL is prohibited between
discontinuation of ibrutinib and enrollment on this trial.

3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199)

4. 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.

5. 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.