A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-313)

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Loxo Oncology

Status and phase

Active, not recruiting
Phase 3

Conditions

Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia

Treatments

Drug: Pirtobrutinib
Drug: Bendamustine
Drug: Rituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05023980
LOXO-BTK-20023
J2N-OX-JZNP (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Confirmed diagnosis of CLL/SLL requiring therapy, per iwCLL 2018 criteria * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 * Adequate organ function * Platelets greater than or equal to (≥)75 x 10⁹/liter (L) (≥50 × 10⁹/L for patients with evidence of bone marrow infiltrate), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10⁹/L * Kidney function: Estimated creatinine clearance ≥40 milliliters per minute (mL/min)

Exclusion criteria

* Known or suspected Richter's transformation at any time preceding enrollment * Prior systemic therapy for CLL/SLL * Presence of 17p deletion * Central nervous system (CNS) involvement * Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \[AIHA\], idiopathic thrombocytopenic purpura \[ITP\]) * Significant cardiovascular disease * Active hepatitis B or hepatitis C * Active cytomegalovirus (CMV) infection * Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection * Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count * Concurrent use of investigational agent or anticancer therapy except hormonal therapy * Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist * Vaccination with a live vaccine within 28 days prior to randomization * Patients with the following hypersensitivity: * Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or bendamustine * Prior significant hypersensitivity to rituximab

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 2 patient groups

Arm A (Pirtobrutinib)
Experimental group
Description:
Pirtobrutinib administered orally
Treatment:
Drug: Pirtobrutinib
Arm B (BR)
Active Comparator group
Description:
Bendamustine plus rituximab administered intravenously (IV)
Treatment:
Drug: Rituximab
Drug: Bendamustine

Trial contacts and locations

146

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Central trial contact

Patient Advocacy

Data sourced from clinicaltrials.gov

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