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NCT Number: NCT05023980

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Small Lymphocytic Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Liverpool Hospital, Liverpool, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pirtobrutinib

Drug

Oral

Other names: LOXO-305, LY3527727

Bendamustine

Drug

IV

Other names: Treanda, Treakisym, Ribomustin, Levact

Rituximab

Drug

IV

Other names: Rituxan, MabThera, Truxima, Riabni, Ruxience

Primary outcomes

  1. To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B)

    Time frame: Up to approximately 5 years

    Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Response Criteria

Secondary outcomes

  1. To evaluate the effectiveness of Arm A compared to Arm B: Progression-free survival (PFS)

    Time frame: Up to approximately 5 years

    Assessments of effectiveness include PFS, assessed by investigator

  2. To evaluate the effectiveness of Arm A compared to Arm B: Overall survival (OS)

    Time frame: Up to approximately 5 years

    Assessments of effectiveness include OS, assessed by investigator

  3. To evaluate the effectiveness of Arm A compared to Arm B: Time to next treatment (TTNT)

    Time frame: Up to approximately 5 years

    Assessments of effectiveness include TTNT, assessed by investigator

  4. To evaluate the effectiveness of Arm A compared to Arm B: Overall response rate (ORR)

    Time frame: Up to approximately 5 years

    Assessments of effectiveness include ORR, assessed by investigator and IRC

  5. To evaluate the effectiveness of Arm A compared to Arm B: Duration of Response (DOR)

    Time frame: Up to approximately 5 years

    Assessments of effectiveness include DOR, assessed by investigator and IRC

  6. To evaluate the effectiveness of Arm A compared to Arm B in patient-reported disease-related symptoms

    Time frame: Up to approximately 5 years

    Based on time to worsening of CLL/SLL-related symptoms

  7. To evaluate the effectiveness of Arm A compared to Arm B in patient-reported physical functioning

    Time frame: Up to approximately 5 years

    Based on time to worsening of physical functioning

Sponsors and collaborators

Lead sponsor

Loxo Oncology, Inc.

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Acronym: BRUIN CLL-313

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Aug 27, 2021
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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