Clinical Trials in China / NCT05479994
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
Condition(s) studied
LeukemiaLymphomaRefractory Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaSmall Lymphocytic LymphomaRelapsed Chronic Lymphocytic Leukemia
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More BeiGene trials in China
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A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL
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Other trials for the same condition
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