Spots Global Cancer Trial Database for A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies
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Trial Identification
Brief Title: A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies
Official Title: A Phase 1/1b Open-Label Dose-Escalation Study of Bcl-2 Inhibitor BGB-21447 in Patients With Mature B-Cell Malignancies
Study ID: NCT05828589
Conditions
Interventions
Study Description
Brief Summary: This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose (MTD), maximum adminstered dose (MAD), recommended Phase 2 dose (RP2D), and pharmacokinetic profile of the drug. Additionally, preliminary antitumor activity will be characterized. The study is divided into 2 main parts: Part 1 "Monotherapy Dose Finding" and Part 2 "Monotherapy Dose Expansion."
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Linear Clinical Research, Nedlands, Western Australia, Australia
Peking University Third Hospital, Beijing, Beijing, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu, Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
Shandong Provincial Hospital, Jinan, Shandong, China
Linyi Peoples Hospital, Linyi, Shandong, China
Affiliated Zhongshan Hospital of Fudan University, Shanghai, Shanghai, China
Institute of Hematology and Hospital of Blood Disease, Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Contact Details
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