A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) plus Venetoclax and Rituximab versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507698-16-00

Acronym

LOXO-BTK-20022

Enrollment

262

Registered

2024-06-12

Start date

2021-10-14

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)

Brief summary

PFS per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018, assessed by Independent Review Committee (IRC)

Interventions

DRUGPIRTOBRUTINIB

DRUGVENETOCLAX

DRUGRITUXIMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018, assessed by Independent Review Committee (IRC)	—

Countries

Belgium, Czechia, Denmark, France, Germany, Hungary, Ireland, Italy, Poland, Spain, Sweden

Outcome results

None listed

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