A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Running, not enrolling · Phase 3
Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
In brief
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.
Key facts
- Study ID
- NCT05023980
- Run by
- Loxo Oncology, Inc.
- People needed
- 309
- Starts
- 2021-09-23
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Innovative Clinical Research Institute — Whittier, California, United States
- Oncology-Hematology Associates of West Broward — Coral Springs, Florida, United States
- New Jersey Center for Cancer Research — Brick, New Jersey, United States
- Clinical Research Alliance, Inc. — Westbury, New York, United States
- Liverpool Hospital — Liverpool, New South Wales, Australia
- Westmead Hospital — Wentworthville, New South Wales, Australia
- Peninsula Private Hospital — Frankston, Victoria, Australia
- Uniklinikum Salzburg — Salzburg, Austria
- Klinik Ottakring — Vienna, Austria
- Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
- Irmandade da Santa Casa de Misericórdia de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
- Centro Gaucho Integrado - Mae de Deus Center — Porto Alegre, Rio Grande do Sul, Brazil
- Hemocentro Unicamp — Campinas, São Paulo, Brazil
- Fundação Doutor Amaral Carvalho — Jaú, São Paulo, Brazil
- UMHAT "Sveti Georgi" EAD — Plovdiv, Bulgaria
- UMHAT 'Sv. Ivan Rilski', EAD — Sofia, Bulgaria
- "SHATHD" EAD, Sofia — Sofia, Bulgaria
- UMHAT - Prof. Dr. Stoyan Kirkovich" AD — Stara Zagora, Bulgaria
- Anhui Provincial Cancer Hospital — Hefei, Anhui, China
- Peking University First Hospital — Beijing, Beijing Municipality, China
- Peking University Third Hospital — Beijing, Beijing Municipality, China
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
- Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China
- Xiangya Hospital Central South University — Changsha, Hunan, China
- California Research Institute — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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