ACALABRUTINIB TAB
Clinical Criteria Summary
Exclusion Criteria
- Patient has not been screened for Hepatitis B Virus (HBV)
- Unmanageable drug-drug interaction identified
- History of stroke or intracranial hemorrhage in prior 6 months
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure (NYHA Class 3 or 4), or myocardial infarction in prior 6 months
- Active or uncontrolled infection
- Severe hepatic impairment (Child-Pugh C)
- Known pregnancy
- Lactating
Inclusion Criteria
- Mantle Cell Lymphoma (MCL) and progressive disease or intolerance to at least one prior therapy
- Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
- Acalabrutinib is not effective in the setting of the BTKC481S mutation that confers resistance to ibrutinib
Additional Inclusion Criteria
- Care provided by a VA/VA Community Care hematology/oncology provider
- Goals of care and role of Palliative Care consult have been discussed and documented
- Eastern Cooperative Oncology Group Performance Status 0-2
Additional Inclusion Criteria (Select if applicable)
- For females who can become pregnant: Counseling on potential risks vs. benefits of treatment and the use of effective contraception during therapy and for at least one week after the last dose
- Advise females not to breastfeed during treatment and for at least 2 weeks after the last dose