A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Спонсор: BeOne Medicines
Налично на:
БГ
Обобщение
The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (bendamustine plus rituximab or high-dose methylprednisolone plus rituximab) in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to covalent Bruton tyrosine kinase inhibitor(s) (cBTKi).
Описание
Chronic lymphocytic leukemia and small lymphocytic lymphoma are types of blood cancer that affects people around the world. People with CLL and SLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms.
In this study, participants with R/R CLL or SLL who were previously exposed to a covalent BTKi will receive BGB-16673 or the investigator's choice of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab. The main purpose of this study is to compare the length of time that participants live without their CLL or SLL worsening between those participants who receive BGB-16673 versus the investigator's choice of treatment. Approximately 150 participants will be included in this study in Mainland China and Taiwan. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment.
Кой може да участва
Inclusion Criteria:
1. Confirmed diagnosis of CLL/SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
2. Previously received treatment for CLL/SLL with a covalent BTKi.
3. Measurable disease by computer tomography/magnetic resonance imaging for patients with SLL.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5. Adequate bone marrow function
6. Adequate kidney and liver function
7. Adequate blood clotting function
Exclusion Criteria:
1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
2. 2\. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or chimeric antigen receptor-T cell (unless ≥ 6 months after cell infusion)
3. History of severe allergic reactions or hypersensitivity to the active ingredient and excipients of study treatment (BGB-16673, bendamustine, or rituximab)
4. Current or history of central nervous system involvement
5. History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
6. History of confirmed progressive multifocal leukoencephalopathy.
7. Active fungal, bacterial, and/or viral infection requiring parenteral systemic therapy
8. Clinically significant cardiovascular disease
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Интервенции
BGB-16673
DRUG
Bendamustine
DRUG
Rituximab
DRUG
Methylprednisolone
DRUG
Места на провеждане
64
Китай (59)
Peking University Third Hospital
Beijing , Beijing Municipality
Peking University Peoples Hospital
Beijing , Beijing Municipality
Peking Union Medical College Hospital
Beijing , Beijing Municipality
Binzhou Medical University Hospital
Binzhou , Shandong
The First Hospital of Jilin University
Changchun , Jilin
The First Peoples Hospital of Changde City
Changde , Hunan
The Second Xiangya Hospital of Central South University
Changsha , Hunan
The First Peoples Hospital of Changzhou
Changzhou , Jiangsu
Sichuan Cancer Hospital and Institute
Chengdu , Sichuan
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu , Sichuan
Chongqing University Three Gorges Central Hospital
Chongqing , Chongqing Municipality
The First Affiliated Hospital of Chongqing Medical University
Chongqing , Chongqing Municipality
Affiliated Zhongshan Hospital of Dalian University
Dalian , Liaoning
Deyangs People Hospital
Deyang , Sichuan
Fujian Medical University Union Hospital
Fuzhou , Fujian
The First Affiliated Hospital of Fujian Medical University
Fuzhou , Fujian
Zhujiang Hospital of Southern Medical University
Guangzhou , Guangdong
Sun Yat Sen University Cancer Centerhuangpu Branch
Guangzhou , Guangdong
Guizhou Provincial Peoples Hospital
Guiyang , Guizhou
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou , Zhejiang
Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch
Hangzhou , Zhejiang
Harbin Medical University Cancer Hospital
Harbin , Heilongjiang
The First Affiliated Hospital of Harbin Medical Universitynangang Branch
Harbin , Heilongjiang
The First Affiliated Hospital of Anhui Medical University
Hefei , Anhui
Affiliated Hospital of Jining Medical University
Jining , Shandong
The First Peoples Hospital of Kashgar
Kashgar , Xinjiang
The First Peoples Hospital of Yunnan Province
Kunming , Yunnan
Linyi Cancer Hospital
Linyi , Shandong
Lishui Central Hospital
Lishui , Zhejiang
The First Affiliated Hospital of Henan University of Science and Technologykaiyuan Branch
Luoyang , Henan
Meizhou People Hospital
Meizhou , Guangdong
The Second Affiliated Hospital of Nanchang University
Nanchang , Jiangxi
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing , Jiangsu
Jiangsu Province Hospital
Nanjing , Jiangsu
The First Affiliated Hospital of Guangxi Medical University
Nanning , Guangxi
Affiliated Hospital of Nantong University
Nantong , Jiangsu
Nanyang Central Hospital
Nanyang , Henan
Fudan University Shanghai Cancer Center
Shanghai , Shanghai Municipality
Shenzhen Nanshan Peoples Hospital
Shenzhen , Guangdong
Taihe Hospital
Shiyan , Hubei
The First Affiliated Hospital of Soochow University
Suzhou , Jiangsu
Taian City Central Hospital
Taian , Shandong
Shanxi Bethune Hospital
Taiyuan , Shanxi
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
Tianjin , Tianjin Municipality
Peoples Hospital of Xinjiang Uygur Autonomous Region
Ürümqi , Xinjiang
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou , Zhejiang
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan , Hubei
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan , Hubei
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an , Shaanxi
Qinghai University Affiliated Hospital
Xining , Qinghai
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang , Henan
Xuchang Central Hospitalluminghu Branch
Xuchang , Henan
The Affiliated Hospital of Xuzhou Medical University
Xuzhou , Jiangsu
The Second Peoples Hospital of Yibin
Yibin , Sichuan
Yichang Central Peoples Hospital
Yichang , Hubei
Red Cross Hospital of Yulin City
Yulin , Guangxi
Henan Cancer Hospital
Zhengzhou , Henan
Henan Provincial Peoples Hospital
Zhengzhou , Henan
The First Affiliated Hospital of Zhengzhou University
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