Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- Conditions
- LeukemiaLymphomaRefractory Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaSmall Lymphocytic LymphomaRelapsed Chronic Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT05479994
- Lead Sponsor
- BeiGene
- Brief Summary
The purpose of this study is to evaluate the efficacy of BGB-11417 in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Arm BGB-11417 Participants will receive BGB-11417 orally until disease progression, intolerable toxicity, or other scenarios specified in the protocol
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC) Up to 2 Years Defined as the proportion of participants who achieved a complete response (CR), complete remission with incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR) per the 2018 iwCLL guidelines for participants with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for partiticpants with small lymphocytic lymphoma (SLL)
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) as assessed by the investigator Up to 2 Years Defined as the proportion of participants who achieved a complete response (CR), complete remission with incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR) per the 2018 iwCLL guidelines for participants with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for participants with small lymphocytic lymphoma (SLL)
Duration of response (DoR) as determined by the IRC and the investigator Up to 5 Years DoR is defined as the time from first determination of response until first documentation of progression or death, whichever occurs first
Progression Free Survival (PFS) as determined by the IRC and the investigator Up to 5 Years PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurs first.
Time to Response (TTR) as assessed by investigator and IRC Up to 2 Years TTR is defined as the time from treatment initiation to the first documented response.
Overall Survival (OS) Up to 5 Years defined as time from the start of treatment to the date of death due to any cause
Participants Reported Outcome as measured by EQ-5D-5L questionnaires Up to 5 Years The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to).
Participant Reported Outcomes as measured by NFLymSI-18 Up to 5 Years The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (NFLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score.
Number of participants with clinically significant changes from baseline in vital signs Up to 5 Years Vital signs include systolic and diastolic blood pressure, heart rate, and body temperature
Number of participants with clinically significant changes from baseline in clinical laboratory values Up to 5 Years Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Up to 5 Years with adverse events leading to discontinuation, and AEs graded according NCI-CTCAE Version 5 and the Grading Scale for Hematologic Toxicity in CLL Studies
Number of Participants With Clinically Significant Physical Examination Findings Up to 5 Years A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems
Trial Locations
- Locations (50)
Hainan Cancer Hospital
🇨🇳Haikou, Hainan, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
Nanyang Central Hospital
🇨🇳Nanyang, Henan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Ningbo First Hospital
🇨🇳Ningbo, Zhejiang, China
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
🇨🇳Hefei, Anhui, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Jishuitan Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital, Capital Medical University(Tongzhou)
🇨🇳Beijing, Beijing, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Quanzhou First Affliated Hospital of Fujian Medical University
🇨🇳Quanzhou, Fujian, China
The Second Affiliated Hospital of Fujian Medical University Donghai Campus
🇨🇳Quanzhou, Fujian, China
Zhangzhou Municipal Hospital of Fujian Province
🇨🇳Zhangzhou, Fujian, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Yuebei Peoples Hospital
🇨🇳Shaoguan, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Red Cross Hospital of Yulin City
🇨🇳Yulin, Guangxi, China
Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Affiliated Hospital of Jiangnan University South Campus
🇨🇳Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Northern Jiangsu Peoples Hospital
🇨🇳Yangzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Tonghua Center Hospital
🇨🇳Tonghua, Jilin, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shaanxi Provincial Peoples Hospital
🇨🇳Xian, Shaanxi, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Jining No Peoples Hospital West Branch
🇨🇳Jining, Shandong, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shandong, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Affiliated Zhongshan Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
The Third Peoples Hospital of Datong
🇨🇳Datong, Shanxi, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
Dazhou Central Hospital
🇨🇳Dazhou, Sichuan, China
Peoples Hospital of Deyang City
🇨🇳Deyang, Sichuan, China
Institute of Hematology and Hospital of Blood Disease
🇨🇳Tianjin, Tianjin, China
The First Peoples Hospital of Kashgar
🇨🇳Kashgar, Xinjiang, China
Affiliated Cancer Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China