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Clinical Trials in the UK / NCT05023980
Active, not recruiting Phase 3

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

NCT05023980 · tracked via the Priya Life Science UK tracker
Sponsor
Loxo Oncology, Inc.
Phase
Phase 3
Started
2021-09-23
Last updated
2026-01-22

Condition(s) studied

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Investigational drug(s) / intervention(s)

PirtobrutinibBendamustineRituximab

Pirtobrutinib: Oral

Bendamustine: IV

Rituximab: IV

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (108)

FacilityCityRegionStatus
California Research Institute Los Angeles California
Innovative Clinical Research Institute Whittier California
Oncology-Hematology Associates of West Broward Coral Springs Florida
New Jersey Center for Cancer Research Brick New Jersey
Clinical Research Alliance, Inc. Westbury New York
Liverpool Hospital Liverpool New South Wales
Westmead Hospital Wentworthville New South Wales
Peninsula Private Hospital Frankston Victoria
Uniklinikum Salzburg Salzburg Austria
Klinik Ottakring Vienna Austria
Hospital de Clinicas de Porto Alegre Porto Alegre Rio Grande do Sul
Irmandade da Santa Casa de Misericórdia de Porto Alegre Porto Alegre Rio Grande do Sul
Centro Gaucho Integrado - Mae de Deus Center Porto Alegre Rio Grande do Sul
Hemocentro Unicamp Campinas São Paulo
Fundação Doutor Amaral Carvalho Jaú São Paulo
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
Peking University First Hospital Beijing Beijing Municipality
Peking University Third Hospital Beijing Beijing Municipality
The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong
Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei
Xiangya Hospital Central South University Changsha Hunan
Hunan Cancer Hospital Changsha Hunan
The Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
Shengjing Hospital of China Medical University Shenyany Liaoning
Jiangsu Province Hospital Nanjing Nanjing
Shanghai Tongren Hospital Changning District Shanghai Municipality
West China Hospital of Sichuan University Chengdu Sichuan
Institute of hematology&blood disease hospital Tianjin Tianjin Municipality
Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin Municipality
The First People's Hospital of Hangzhou Linping District Hangzhou Zhejiang
Beijing Hospital Beijing China
Chongqing Cancer Hospital Chongqing China
Henan Cancer Hospital Zhengzhou China
Fakultni nemocnice Brno Brno Czechia
Fakultni nemocnice Hradec Kralove Hradec Králové Czechia

+ 68 more sites — see the full list on the official registry below.

On this site

📄 Rituxan (rituximab) drug profile →

More Loxo Oncology, Inc. trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05023980 on ClinicalTrials.gov ↗ ← All trials in the UK