Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of BCL2 Inhibitor BGB-11417 in Adult Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
2 other identifiers
interventional
100
1 country
50
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 leukemia
Started Oct 2022
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2022
CompletedFirst Posted
Study publicly available on registry
July 29, 2022
CompletedStudy Start
First participant enrolled
October 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2027
ExpectedMarch 4, 2026
March 1, 2026
2.3 years
July 27, 2022
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
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)
Up to 2 Years
Secondary Outcomes (11)
Overall Response Rate (ORR) as assessed by the investigator
Up to 2 Years
Duration of response (DoR) as determined by the IRC and the investigator
Up to 5 Years
Progression Free Survival (PFS) as determined by the IRC and the investigator
Up to 5 Years
Time to Response (TTR) as assessed by investigator and IRC
Up to 2 Years
Overall Survival (OS)
Up to 5 Years
- +6 more secondary outcomes
Study Arms (1)
Treatment Arm
EXPERIMENTALParticipants will receive BGB-11417 orally until disease progression, intolerable toxicity, or other scenarios specified in the protocol
Interventions
Eligibility Criteria
You may qualify if:
- Participants with a histologically confirmed diagnosis of CLL/SLL based on the International Workshop on CLL (iwCLL) criteria:
- Treatment intolerance or failure during or after treatment with chemoimmunotherapy (CIT) and BTK inhibitors (BTKi) or
- Treatment intolerance or failure during or after treatment with BTKi for CIT-ineligible participants as assessed by the investigator.
- Participants who require treatment based on the iwCLL 2018 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
- Life expectancy of \> 6 month
You may not qualify if:
- Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or low risk (Gleason score ≤ 6) localized prostate cancer
- Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results
- A known history of or currently suspected Richter's syndrome
- Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or prior chimeric cell therapy (unless ≥ 6 months after cell infusion)
- Prior allogeneic stem cell transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (50)
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui, 230088, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100000, China
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100003, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Beijing Friendship Hospital, Capital Medical University(Tongzhou)
Beijing, Beijing Municipality, 101100, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000, China
The Second Affiliated Hospital of Fujian Medical University Donghai Campus
Quanzhou, Fujian, 362018, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363000, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000, China
Yuebei Peoples Hospital
Shaoguan, Guangdong, 512000, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Red Cross Hospital of Yulin City
Yulin, Guangxi, 537000, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004, China
Hainan Cancer Hospital
Haikou, Hainan, 570312, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
Nanyang Central Hospital
Nanyang, Henan, 473000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010050, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Affiliated Hospital of Jiangnan University South Campus
Wuxi, Jiangsu, 214122, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
Northern Jiangsu Peoples Hospital
Yangzhou, Jiangsu, 225001, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Tonghua Center Hospital
Tonghua, Jilin, 134099, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Shaanxi Provincial Peoples Hospital
Xi'an, Shaanxi, 710068, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Jining No Peoples Hospital West Branch
Jining, Shandong, 272000, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
The Third Peoples Hospital of Datong
Datong, Shanxi, 037008, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
Dazhou Central Hospital
Dazhou, Sichuan, 635099, China
Peoples Hospital of Deyang City
Deyang, Sichuan, 618000, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, 300020, China
The First Peoples Hospital of Kashgar
Kashgar, Xinjiang, 844099, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650100, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Ningbo First Hospital
Ningbo, Zhejiang, 315010, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2022
First Posted
July 29, 2022
Study Start
October 25, 2022
Primary Completion
January 24, 2025
Study Completion (Estimated)
August 25, 2027
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.