An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma

Inclusion criteria:

- Men and women ≥ 18 years of age.

- Pathologically confirmed MCL, with documentation of monoclonal B cells that have a
chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1.

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

- Agreement to use contraception during the study and for 30 days after the last dose of
study drugs if sexually active and able to bear or beget children.

Exclusion criteria:

- A life-threatening illness, medical condition or organ system dysfunction which, in
the investigator's opinion, could compromise the subject's safety, interfere with the
absorption or metabolism of ACP-196 (acalabrutinib), or put the study outcomes at
undue risk

- Significant cardiovascular disease such as uncontrolled or symptomatic 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 corrected QT interval (QTc) > 480 msec.

- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel or ulcerative colitis, symptomatic
inflammatory bowel disease, or partial or complete bowel obstruction.

- Breast feeding or pregnant