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

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About the study

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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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Confirmed diagnosis of CLL/SLL requiring therapy, per iwCLL 2018 criteria
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  3. Adequate organ function
  4. 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
  5. Kidney function: Estimated creatinine clearance ≥40 milliliters per minute (mL/min)

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Known or suspected Richter's transformation at any time preceding enrollment
  2. Prior systemic therapy for CLL/SLL
  3. Presence of 17p deletion
  4. Central nervous system (CNS) involvement
  5. Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
  6. Significant cardiovascular disease
  7. Active hepatitis B or hepatitis C
  8. Active cytomegalovirus (CMV) infection
  9. Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  10. Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
  11. Concurrent use of investigational agent or anticancer therapy except hormonal therapy
  12. Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
  13. Vaccination with a live vaccine within 28 days prior to randomization

Patients with the following hypersensitivity:

  1. Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or bendamustine
  2. Prior significant hypersensitivity to rituximab
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-855-LOXO-305Email iconEmail Study Center

Study’s details


Contition
Chronic Lymphocytic Leukemia,Small Lymphocytic Lymphoma
Age (in years)
18+
Phase
Phase 3
Participants needed
250
Est. Completion Date
Jul 31, 2026
Treatment type
Interventional

Sponsor
Eli Lilly and Company
ClinicalTrials.gov identifier
NCT05023980
Study number
LOXO-BTK-20023

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