Spots Global Cancer Trial Database for Study to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia
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Trial Identification
Brief Title: Study to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia
Official Title: An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of BCL2 Inhibitor BGB-11417 in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia
Study ID: NCT05952037
Interventions
Study Description
Brief Summary: This study will evaluate the safety and efficacy of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.
Detailed Description: This study will test whether BGB-11417 can be used to improve outcomes in participants with Waldenström's Macroglobulinemia (WM) who have not responded well to conventional treatments. The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment, and to determine what adverse events, or side effects, participants might experience. BCL2 is a key protein involved in cell death, and abnormal levels of BCL2 are associated with many cancers. Blocking the action of BCL2 proteins is a promising approach with potential therapeutic benefits in participants with different types of cancers, including WM. This study will enroll approximately 85 patients. All patients will receive BGB-11417 orally as a tablet. The study will take place at multiple centers worldwide. The overall time to participate in this study is approximately 5 years. Treatments will continue until participants experience worsening disease status, too many side effects, or withdraw consent.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
University of Miami, Miami, Florida, United States
Mission Cancer and Blood, Des Moines, Iowa, United States
University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Hattiesburg Hematology and Oncology Clinic, Hattiesburg, Mississippi, United States
Memorial Sloan Kettering Cancer Center Mskcc, New York, New York, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Concord Repatriation General Hospital, Concord, New South Wales, Australia
Genesiscare North Shore, St Leonards, New South Wales, Australia
Princess Alexandra Hospital, Brisbane, Queensland, Australia
Flinders Medical Centre, Bedford PK, South Australia, Australia
Monash Health, Clayton, Victoria, Australia
St Vincents Hospital Melbourne, Fitzroy, Victoria, Australia
Guangdong Provincial Peoples Hospital, Guangzhou, Guangdong, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
Shengjing Hospital Affiliated of China Medical University, Shenyang, Liaoning, China
The Affiliated Hospital of Qingdao University Branch South, Qingdao, 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
The First Hospital of Jiaxing, Jiaxing, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Chu Clermont Ferrand Therapie Cellulaire and Hematolo, Clermont Ferrand, , France
Institut Paoli Calmettes, Marseille, , France
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Churchill Hospital Oxford University Hospital Nhs Trust, Headington, , United Kingdom
Contact Details
Name: Study Director
Affiliation: BeiGene
Role: STUDY_DIRECTOR
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