A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator Choice of BTK Inhibitor in Patients with Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN-MCL-321)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507695-52-00

Acronym

LOXO-BTK-20019

Enrollment

197

Registered

2024-06-12

Start date

2021-03-05

Completion date

Unknown

Last updated

2025-11-19

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

Assessed by independent review committee (IRC) • Progression-free survival (PFS) per Lugano criteria

Interventions

DRUGPIRTOBRUTINIB

DRUGIBRUTINIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Assessed by independent review committee (IRC) • Progression-free survival (PFS) per Lugano criteria	—

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

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