A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL
Trial Status: Active
This is a multicenter, open-label Phase 1b study to assess the safety and efficacy of acalabrutinib when administered concomitantly with bendamustine and rituximab in subjects with treatment naive or relapse refractory mantle cell lymphoma (Part 1), or when administered concomitantly with venetoclax and rituximab in subjects with treatment naive mantle cell lymphoma (Part 2).
- 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 2 days after the last dose of acalabrutinib, 30 days after the last dose of venetoclax, or 12 months after the last dose of rituximab, whichever is longest.
- Treatment Naive MCL patients requiring treatment with no exposure to prior therapies.
- Significant cardiovascular disease such as uncontrolled or untreated 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.Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, 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
- Concurrent participation in another therapeutic clinical trial.
University of Michigan Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
M D Anderson Cancer Center
Fred Hutch / University of Washington Cancer Consortium
Contact: Stephen Douglas Smith
Trial Phase Phase I
Trial Type Treatment
Acerta Pharma BV
- Primary ID ACE-LY-106
- Secondary IDs NCI-2016-00662
- Clinicaltrials.gov ID NCT02717624