SHS_492317 PAGJ CACT 16065

A Phase 1b, Multicenter, Open-label Study of ACP-196 in Combination With Bendamustine and Rituximab (BR) in Subjects With Mantle Cell Lymphoma

The purpose of this study is to characterize the safety profile of ACP-196 in combination with bendamustine and rituximab in subjects with treatment naive and relapse/refractory Mantle Cell Lymphoma (MCL).

Inclusion Criteria:

•Men and women ≥ 18 years of age.
•Pathologically confirmed MCL.
•Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
•Agreement to use highly effective forms of contraception during the study and for 90 days after the last dose of ACP 196, 120 days after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longest.

Exclusion Criteria:

•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
•Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass
•Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks before first dose of study drug
•Breastfeeding or pregnant
Phase Ib
NCT02717624
Cancer
Hematologic
John Pagel, M.D.
Acerta Pharma BV
Neil Bailey
  • Swedish Medical Center