A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) versus Ibrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507699-38-00

Acronym

LOXO-BTK-20030

Enrollment

377

Registered

2024-04-26

Start date

2022-08-30

Completion date

Unknown

Last updated

2025-10-29

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

Brief summary

Part 1 and Part 2: Primary endpoint: Overall response rate (ORR) as assessed by independent review committee (IRC) per iwCLL 2018 criteria. ORR is defined as the proportion of patients who achieve a BOR of CR, CRi, nPR, or PR at or before the initiation of subsequent anticancer therapy.

Interventions

DRUGPIRTOBRUTINIB

DRUGIBRUTINIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1 and Part 2: Primary endpoint: Overall response rate (ORR) as assessed by independent review committee (IRC) per iwCLL 2018 criteria. ORR is defined as the proportion of patients who achieve a BOR of CR, CRi, nPR, or PR at or before the initiation of subsequent anticancer therapy.	—

Countries

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

Outcome results

None listed

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