Study identifier:ACE-LY-308
ClinicalTrials.gov identifier:NCT02972840
EudraCT identifier:2015-005220-26
CTIS identifier:2023-509354-58-00
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
Lymphoma, Mantle Cell
Phase 3
No
Acalabrutinib, Bendamustine, Rituximab, Placebo
All
635
Interventional
65 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Nov 2024 by AcertaPharma
AcertaPharma
AstraZeneca
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Acalabrutinib in combination with bendamustine and rituximab Acalabrutinib administered twice per day (BID) orally (PO) plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days. | Drug: Acalabrutinib Administered orally (PO) Other Name: ACP-196 Other Name: Calquence Drug: Bendamustine Administered intravenously (IV) Other Name: Treanda Other Name: Bendeka Drug: Rituximab Administered intravenously (IV) Other Name: Rituxan Other Name: Rituxan Hycela |
Placebo Comparator: Placebo in combination with bendamustine and rituximab Matching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days. | Drug: Bendamustine Administered intravenously (IV) Other Name: Treanda Other Name: Bendeka Drug: Rituximab Administered intravenously (IV) Other Name: Rituxan Other Name: Rituxan Hycela Drug: Placebo Placebo comparator Other Name: N/A |