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 (BRUIN CLL-313)

  • STATUS
    Recruiting
  • End date
    Jul 27, 2026
  • participants needed
    250
  • sponsor
    Loxo Oncology, Inc.
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Updated on 27 October 2022
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chronic lymphocytic leukemia
lymphoma
rituximab
neutrophil count
bendamustine

Summary

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.

Details
Condition Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Treatment Rituximab, Bendamustine, Pirtobrutinib
Clinical Study IdentifierNCT05023980
SponsorLoxo Oncology, Inc.
Last Modified on27 October 2022

Eligibility

 Yes No Not Sure

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
Clear my responses
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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