What type of study is this?

This is a Human Clinical Trial study (also classified as: Phase 3).

What question did this study set out to answer?

To compare the efficacy and safety of pirtobrutinib with bendamustine plus rituximab in untreated CLL patients.

December 9, 2025Journal of Clinical OncologyOpen Access

BRUIN CLL-313: Randomized Phase III Trial of Pirtobrutinib Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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Authors

WJWojciech JurczakGoethe University Frankfurt MKMichał KwiatekPoznan University of Medical Sciences JCJarosław CzyżNicolaus Copernicus University

Discussion

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Implication

Randomized trial showed improved progression-free survival in CLL patients treated with pirtobrutinib versus bendamustine plus rituximab, indicating better tolerability.

Key Points

To compare the efficacy and safety of pirtobrutinib with bendamustine plus rituximab in untreated CLL patients.
Randomized, open-label, phase III study
Patients with untreated Chronic Lymphocytic Leukemia were assigned to either pirtobrutinib or BendaR
Progression-free survival assessed by independent review committee as primary endpoint
Secondary endpoints included overall survival, safety, and tolerability
Pirtobrutinib significantly improved IRC-assessed progression-free survival compared to BendaR (HR 0.199)
24-month PFS was 93.4% for pirtobrutinib versus 70.7% for BendaR
Median overall survival favored pirtobrutinib with a hazard ratio of 0.257
Adverse events related dose reductions occurred in 3.6% for pirtobrutinib versus 31.1% for BendaR

Cite This Study

Jurczak et al. (2025) studied this question.

synapsesocial.com/papers/69401d682d562116f28f90b7 https://doi.org/10.1200/jco-25-02380

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Implication

Randomized trial showed improved progression-free survival in CLL patients treated with pirtobrutinib versus bendamustine plus rituximab, indicating better tolerability.

BRUIN CLL-313: Randomized Phase III Trial of Pirtobrutinib Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Discussion

Member takes

Implication

Key Points

Cite This Study

BRUIN CLL-313: Randomized Phase III Trial of Pirtobrutinib Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Discussion

Member takes

Implication

Key Points

Cite This Study

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