Clinical trial NCT05479994: Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Leukemia
Lymphoma
Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Small Lymphocytic Lymphoma
Relapsed Chronic Lymphocytic Leukemia
Keywords: Refractory Chronic Lymphocytic Leukemia
Leukemia
Lymphoma
Small Lymphocytic Lymphoma
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2022-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility criteria: 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 outcomes:
measure: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
timeFrame: Up to 2 Years
Secondary outcomes:
measure: Overall Response Rate (ORR) as assessed by the investigator
timeFrame: Up to 2 Years
measure: Duration of response (DoR) as determined by the IRC and the investigator
timeFrame: Up to 5 Years
measure: Progression Free Survival (PFS) as determined by the IRC and the investigator
timeFrame: Up to 5 Years
measure: Time to Response (TTR) as assessed by investigator and IRC
timeFrame: Up to 2 Years
measure: Overall Survival (OS)
timeFrame: Up to 5 Years
measure: Participants Reported Outcome as measured by EQ-5D-5L questionnaires
timeFrame: Up to 5 Years
measure: Participant Reported Outcomes as measured by NFLymSI-18
timeFrame: Up to 5 Years
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 5 Years
measure: Number of participants with clinically significant changes from baseline in vital signs
timeFrame: Up to 5 Years
measure: Number of participants with clinically significant changes from baseline in clinical laboratory values
timeFrame: Up to 5 Years
measure: Number of Participants With Clinically Significant Physical Examination Findings
timeFrame: Up to 5 Years
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
state: Anhui
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University(Tongzhou)
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Quanzhou
country: China
facility: Quanzhou First Affliated Hospital of Fujian Medical University
state: Fujian
city: Quanzhou
country: China
facility: The Second Affiliated Hospital of Fujian Medical University Donghai Campus
state: Fujian
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital of Fujian Province
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Shaoguan
country: China
facility: Yuebei Peoples Hospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Yulin
country: China
facility: Red Cross Hospital of Yulin City
state: Guangxi
city: Guiyang
country: China
facility: Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Haikou
country: China
facility: Hainan Cancer Hospital
state: Hainan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Nanyang
country: China
facility: Nanyang Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University South Campus
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu Peoples Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University Branch Donghu
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Tonghua
country: China
facility: Tonghua Center Hospital
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Xian
country: China
facility: Shaanxi Provincial Peoples Hospital
state: Shaanxi
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Jining
country: China
facility: Jining No Peoples Hospital West Branch
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Affiliated Zhongshan Hospital of Fudan University
state: Shanghai
city: Datong
country: China
facility: The Third Peoples Hospital of Datong
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Dazhou
country: China
facility: Dazhou Central Hospital
state: Sichuan
city: Deyang
country: China
facility: Peoples Hospital of Deyang City
state: Sichuan
city: Tianjin
country: China
facility: Institute of Hematology and Hospital of Blood Disease
state: Tianjin
city: Kashgar
country: China
facility: The First Peoples Hospital of Kashgar
state: Xinjiang
city: Urumqi
country: China
facility: Affiliated Cancer Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
Study officials:
References: