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Active, not recruiting Phase 2

Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT05479994 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Phase 2
Started
2022-10-25
Last updated
2026-03-04

Condition(s) studied

LeukemiaLymphomaRefractory Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaSmall Lymphocytic LymphomaRelapsed Chronic Lymphocytic Leukemia

Investigational drug(s) / intervention(s)

BGB-11417 →

BGB-11417: Administered orally

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria 1. Participants with a histologically confirmed diagnosis of CLL/SLL based on the International Workshop on CLL (iwCLL) criteria: 1. Treatment intolerance or failure during or after treatment with chemoimmunotherapy (CIT) and BTK inhibitors (BTKi) or 2. Treatment intolerance or failure during or after treatment with BTKi for CIT-ineligible participants as assessed by the investigator. 2. Participants who require treatment based on the iwCLL 2018 criteria 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2 4. Life expectancy of \> 6 month Key Exclusion Criteria 1. 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 2. 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 3. A known history of or currently suspected Richter's syndrome 4. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or prior chimeric cell therapy (unless ≥ 6 months after cell infusion) 5. Prior allogeneic stem cell transplant Note: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcome measure(s)

  • 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)

Trial sites (50)

FacilityCityRegionStatus
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital Hefei Anhui
Peking University Third Hospital Beijing Beijing Municipality
Beijing Jishuitan Hospital Beijing Beijing Municipality
Beijing Hospital Beijing Beijing Municipality
Beijing Friendship Hospital, Capital Medical University(Tongzhou) Beijing Beijing Municipality
Fujian Cancer Hospital Fuzhou Fujian
Quanzhou First Affliated Hospital of Fujian Medical University Quanzhou Fujian
The Second Affiliated Hospital of Fujian Medical University Donghai Campus Quanzhou Fujian
Zhangzhou Municipal Hospital of Fujian Province Zhangzhou Fujian
Lanzhou University Second Hospital Lanzhou Gansu
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong
Yuebei Peoples Hospital Shaoguan Guangdong
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
Red Cross Hospital of Yulin City Yulin Guangxi
Affiliated Hospital of Guizhou Medical University Guiyang Guizhou
Hainan Cancer Hospital Haikou Hainan
The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan
Nanyang Central Hospital Nanyang Henan
Henan Cancer Hospital Zhengzhou Henan
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei
The Second Xiangya Hospital of Central South University Changsha Hunan
Hunan Cancer Hospital Changsha Hunan
The Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia
Zhongda Hospital Southeast University Nanjing Jiangsu
Jiangsu Province Hospital Nanjing Jiangsu
Affiliated Hospital of Jiangnan University South Campus Wuxi Jiangsu
The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu
Northern Jiangsu Peoples Hospital Yangzhou Jiangsu
The First Affiliated Hospital of Nanchang University Branch Donghu Nanchang Jiangxi
The First Hospital of Jilin University Changchun Jilin
Tonghua Center Hospital Tonghua Jilin
Shengjing Hospital of China Medical University Shenyang Liaoning
Shaanxi Provincial Peoples Hospital Xi'an Shaanxi
Shandong Provincial Hospital Jinan Shandong
Shandong Cancer Hospital Jinan Shandong
Jining No Peoples Hospital West Branch Jining Shandong
Yantai Yuhuangding Hospital Yantai Shandong
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality
Affiliated Zhongshan Hospital of Fudan University Shanghai Shanghai Municipality
The Third Peoples Hospital of Datong Datong Shanxi

+ 10 more sites — see the full list on the official registry below.

Official registry record

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 NCT05479994 on ClinicalTrials.gov ↗ ← All trials in China