A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator’s Choice of Idelalisib plus Rituximab or Bendamustine plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-321)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507697-40-00

Acronym

LOXO-BTK-20020

Enrollment

128

Registered

2024-07-04

Start date

2021-07-05

Completion date

Unknown

Last updated

2025-09-30

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

Assessed by Independent Review Committee (IRC): • PFS per iwCLL 2018

Interventions

DRUGIDELALISIB

DRUGPIRTOBRUTINIB

DRUGRITUXIMAB

DRUGBENDAMUSTINE HYDROCHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Assessed by Independent Review Committee (IRC): • PFS per iwCLL 2018	—

Countries

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

Outcome results

None listed

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