A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Independent Review Committee (IRC) — From randomization until documented disease progression or death (up to 40 months)
PFS, as assessed by IRC, is defined as the time from randomization until documented disease progression as per iwCLL (International Workshop on Chronic Lymphocytic Leukemia) 2018 criteria, or death from any cause, whichever occurs first.
Trial sites (108)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
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