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Study of Sonrotoclax (BGB-11417) Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
Sponsor: BeOne Medicines
Summary
The study consists of two parts. Part 1 determines the safety and tolerability of sonrotoclax monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of sonrotoclax monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of sonrotoclax monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.
Official title: A Single-Arm, Open-Label, Multicenter Phase 1/2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BCL2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
125
Start Date
2022-09-05
Completion Date
2027-01-31
Last Updated
2026-09-22
Healthy Volunteers
No
Interventions
Sonrotoclax
Administered orally
Locations (65)
University of Alabama At Birmingham Hospital
Birmingham, Alabama, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Tulane Cancer Center
New Orleans, Louisiana, United States
Maryland Oncology Hematology, Pa
Columbia, Maryland, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Hospital Aleman
Ciudad Autonoma Buenos Aires, Argentina
University Hospitals Leuven
Leuven, Belgium
Hospital Erasto Gaertner
Curitiba, Brazil
Hospital Mae de Deus
Porto Alegre, Brazil
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
Ribeirão Preto, Brazil
Oncoclinicas Rio de Janeiro Sa
Rio de Janeiro, Brazil
Instituto Americas Ensino, Pesquisa E Inovacao
Rio de Janeiro, Brazil
Hospital Sao Rafael (Rede Dor)
Salvador, Brazil
Hospital Beneficencia Portuguesa de Sao Paulo
São Paulo, Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil
Accamargo Cancer Center
São Paulo, Brazil
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University(Tongzhou)
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital Huifu Branch
Guangzhou, Guangdong, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, China
Hainan General Hospital
Haikou, Hainan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Shandong Cancer Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University Branch West Coast
Qingdao, Shandong, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Centre Hospitalier Le Mans
Le Mans, France
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, France
Hopital Pitie Salpetriere Service Hematologie
Paris, France
Necker University Hospital
Paris, France
Chu Hopital Lyon Sud
PierreBenite, France
Chu Tours Hopital Bretonneau Service Pneumologie 2
Tours, France
Universitatsklinikum Koln, Innere Medizin I
Cologne, Germany
Universitatsklinikum Dusseldorf
Düsseldorf, Germany
Assuta Ashdod Medical Center
Ashdod, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, Italy
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Pratia McM Krakow
Krakow, Poland
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico
Hospital Universitario Vall Dhebron
Barcelona, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Ankara University Medical Faculty
Ankara, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara, Turkey (Türkiye)
Vkv American Hospital
Tevikiye, Turkey (Türkiye)
Oxford University Hospitals Nhs Trust Churchill Hospital
Headington, United Kingdom
University College Hospital
London, United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom