Clinical Trials in Japan / 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 Japan tracker
Condition(s) studied
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
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
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)
- 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 Japan
A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Active, not recruiting
Other trials for the same condition
A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Active, not recruiting
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 Japan