An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia

Inclusion Criteria:

- Men and women ≥ 18 years of age

- A confirmed diagnosis of WM, which requires treatment.

- 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 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 LVEF < 40%

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

- Breast feeding or pregnant.