ACE-LY-308 (FL)
A phase 3, randomized, double-blind, placebo-controlled, multicenter study of Bendamustine and Rituximab (BR) alone versus in combination with acalabrutinib (ACP-196) in subjects with previously untreated Mantle Cell Lymphoma (MCL)
Study treatments
| Experimental arm
|
Acalabrutinib (twice daily oral) plus bendamustine (intravenous on days 1 and 2) and rituximab (intravenous on day 1) (cycle of 28 days)
|
| Placebo comparator
|
Matching placebo (twice daily oral) plus bendamustine (intravenous on days 1 and 2) and rituximab (intravenous on day 1) (cycle of 28 days)
|
Inclusion criteria
- Age ≥ 65 years
- Pathologically confirmed mantle cell lymphoma, with documentation of monoclonal CD20+ B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1
- MCL requiring treatment and for which no prior systemic anticancer therapies have been received
- ECOG score of 0-2
Exclusion criteria
- Significant cardiovascular disease
- Malabsorption syndrome and disease significantly affecting gastrointestinal function
- Uncontrolled active systemic fungal, bacterial, viral or other infection
Participating sites
- Ghent university Hospital
- Jan Yperman Ziekenhuis Ieper
- ZNA