A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia
Condition(s) studied
Investigational drug(s) / intervention(s)
Sonrotoclax: Administered orally as a tablet.
Zanubrutinib: Administered orally as a capsule.
Study summary
This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.
Eligibility
Primary outcome measure(s)
- Cohort 1: Major Response Rate (MRR) — Up to approximately 4 years
MRR is defined as the percentage of participants achieving partial response (PR) or better, as assessed by the Independent Review Committee (IRC) per the 11th International Workshop on Waldenström Macroglobulinemia (IWWM-11) WM response criteria.
Trial sites (72)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | |
| Colorado Blood Cancer Institute | Denver | Colorado | |
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | |
| University of Miami | Miami | Florida | |
| Northwestern Medicine Cancer Center | Warrenville | Illinois | |
| Mission Cancer and Blood | Waukee | Iowa | |
| University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Mayo Clinic Rochester | Rochester | Minnesota | |
| Hattiesburg Hematology and Oncology Clinic | Hattiesburg | Mississippi | |
| Memorial Sloan Kettering Cancer Center Mskcc | New York | New York | |
| Atrium Health Levine Cancer Institute (Lci) | Charlotte | North Carolina | |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | |
| Ut Southwestern Medical Center | Dallas | Texas | |
| Huntsman Cancer Institute | Salt Lake City | Utah | |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | |
| University of Washington | Seattle | Washington | |
| Concord Repatriation General Hospital | Concord | New South Wales | |
| Genesiscare North Shore | St Leonards | New South Wales | |
| Princess Alexandra Hospital | Woolloongabba | Queensland | |
| Flinders Medical Centre | Bedford PK | South Australia | |
| Monash Health | Clayton | Victoria | |
| St Vincents Hospital Melbourne | Fitzroy | Victoria | |
| Linear Clinical Research | Nedlands | Western Australia | |
| Royal Perth Hospital | Perth | Western Australia | |
| Cross Cancer Institute | Edmonton | Alberta | |
| Lions Gate Hospital Chemotherapy Clinic | North Vancouver | British Columbia | |
| Qeii Health Science Center | Halifax | Nova Scotia | |
| Princess Margaret Cancer Centre | Toronto | Ontario | |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | |
| Guangdong Provincial Peoples Hospital | Guangzhou | Guangdong | |
| Henan Cancer Hospital | Zhengzhou | Henan | |
| Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | |
| Yancheng First Peoples Hospital | Yancheng | Jiangsu | |
| Shengjing Hospital of China Medical Universityshenbei Branch | Shenyang | Liaoning | |
| The Affiliated Hospital of Qingdao University Branch South | Qingdao | Shandong | |
| Affiliated Zhongshan Hospital of Fudan University | Shanghai | Shanghai Municipality | |
| The Third Peoples Hospital of Datong | Datong | Shanxi | |
| Institute of Hematology and Hospital of Blood Disease | Tianjin | Tianjin Municipality | |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang |
+ 32 more sites — see the full list on the official registry below.
On this site
📄 Brukinsa (zanubrutinib) drug profile →More BeOne Medicines trials in Italy
Other trials for the same condition
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 NCT05952037 on ClinicalTrials.gov ↗ ← All trials in Italy