FindTrial
Sign In

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509354-58-00
Acronym
ACE-LY-308
Enrollment
198
Registered
2024-05-31
Start date
2017-07-14
Completion date
Unknown
Last updated
2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mantle Cell Lymphoma

Brief summary

The primary endpoint of the study is PFS as assessed by IRC per the Lugano Classification for NHL. The primary analysis is a comparison of PFS between Arm 1 (acalabrutinib plus BR) and Arm 2 (placebo plus BR).

Detailed description

Investigator-assessed PFS per the Lugano Classification for NHL, Investigator-assessed ORR (CR+PR) per the Lugano Classification for NHL, IRC-assessed ORR (CR+PR) per the Lugano Classification for NHL, OS, IRC-assessed DOR per the Lugano Classification for NHL, IRC assessed TTR per the Lugano Classification for NHL, IRC-assessed ORR (CR + PR) per Revised Response Criteria for Malignant Lymphoma (Cheson 2007), PRO as measured by change in scores from baseline to each assessment using the FACT-Lym scale, PRO as measured by change in scores from baseline to each assessment using the EQ-5D-5L index score

Interventions

DRUGRITUXIMAB
DRUGBENDAMUSTINE
DRUGCapsule
DRUGhard
DRUGCalquence 100 mg hard capsules

Sponsors

Acerta Pharma B.V.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study is PFS as assessed by IRC per the Lugano Classification for NHL. The primary analysis is a comparison of PFS between Arm 1 (acalabrutinib plus BR) and Arm 2 (placebo plus BR).—

Secondary

MeasureTime frame
Investigator-assessed PFS per the Lugano Classification for NHL, Investigator-assessed ORR (CR+PR) per the Lugano Classification for NHL, IRC-assessed ORR (CR+PR) per the Lugano Classification for NHL, OS, IRC-assessed DOR per the Lugano Classification for NHL, IRC assessed TTR per the Lugano Classification for NHL, IRC-assessed ORR (CR + PR) per Revised Response Criteria for Malignant Lymphoma (Cheson 2007), PRO as measured by change in scores from baseline to each assessment using the FACT-Lym scale, PRO as measured by change in scores from baseline to each assessment using the EQ-5D-5L index score—

Countries

Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026