RecruitingPhase 3NCT06970743

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

A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent BTK Inhibitors

Sponsor

BeOne Medicines

Enrollment

150 participants

Start Date

May 29, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new drug called BGB-16673 against standard treatments chosen by doctors for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose cancer has stopped responding to an older class of targeted drugs called covalent BTK inhibitors (such as ibrutinib or acalabrutinib). **You may be eligible if...** - You have confirmed CLL or SLL and need treatment - You have previously received a covalent BTK inhibitor and your cancer has progressed on or after it - You have measurable disease on imaging - Your overall health is good enough for treatment (ECOG performance status 0–2) - Your organ function meets minimum study requirements **You may NOT be eligible if...** - You have Richter's transformation (your CLL has converted into an aggressive lymphoma) - You have active autoimmune conditions requiring treatment - You have active CNS (brain) involvement of your cancer - You are pregnant or breastfeeding - You have severe uncontrolled infections or significant organ failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGB-16673

Administered orally

DRUGBendamustine

Administered intravenously

DRUGRituximab

Administered intravenously

DRUGMethylprednisolone

Administered intravenously

Locations(64)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Peking University Peoples Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Chongqing University Three Gorges Central Hospital

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Sun Yat Sen University Cancer Centerhuangpu Branch

Guangzhou, Guangdong, China

Meizhou People Hospital

Meizhou, Guangdong, China

Shenzhen Nanshan Peoples Hospital

Shenzhen, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Red Cross Hospital of Yulin City

Yulin, Guangxi, China

Guizhou Provincial Peoples Hospital

Guiyang, Guizhou, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Harbin Medical Universitynangang Branch

Harbin, Heilongjiang, China

The First Affiliated Hospital of Henan University of Science and Technologykaiyuan Branch

Luoyang, Henan, China

Nanyang Central Hospital

Nanyang, Henan, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Xuchang Central Hospitalluminghu Branch

Xuchang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Henan Provincial Peoples Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Taihe Hospital

Shiyan, Hubei, China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Yichang Central Peoples Hospital

Yichang, Hubei, China

The First Peoples Hospital of Changde City

Changde, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Peoples Hospital of Changzhou

Changzhou, Jiangsu, China

Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

Qinghai University Affiliated Hospital

Xining, Qinghai, China

The Second Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Binzhou Medical University Hospital

Binzhou, Shandong, China

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

Taian City Central Hospital

Taian, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Sichuan Cancer Hospital and Institute

Chengdu, Sichuan, China

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, Sichuan, China

Deyangs People Hospital

Deyang, Sichuan, China

The Second Peoples Hospital of Yibin

Yibin, Sichuan, China

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch

Tianjin, Tianjin Municipality, China

The First Peoples Hospital of Kashgar

Kashgar, Xinjiang, China

Peoples Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

The First Peoples Hospital of Yunnan Province

Kunming, Yunnan, China

The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch

Hangzhou, Zhejiang, China

Lishui Central Hospital

Lishui, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Chang Bing Show Chwan Memorial Hospital

Changhua, Taiwan

National Cheng Kung University Hospital

North Dist, Taiwan

China Medical University Hospital

Taichung, Taiwan

Koo Foundation Sun Yat Sen Cancer Center

Taipei, Taiwan

National Taiwan University Hospital

Zhongzheng Dist, Taiwan

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