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

Last updated: February 19, 2025
Sponsor: BeiGene
Overall Status: Active - Not Recruiting

Phase

2

Condition

Leukemia

Lymphoma

Marginal Zone Lymphoma

Treatment

BGB-11417

Clinical Study ID

NCT05479994
BGB-11417-202
CTR20222085
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Key Inclusion Criteria

  1. Participants with a histologically confirmed diagnosis of CLL/SLL based on the International Workshop on CLL (iwCLL) criteria:

  2. Treatment intolerance or failure during or after treatment with chemoimmunotherapy (CIT) and BTK inhibitors (BTKi) or

  3. Treatment intolerance or failure during or after treatment with BTKi for CIT-ineligible participants as assessed by the investigator.

  4. Participants who require treatment based on the iwCLL 2018 criteria

  5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2

  6. 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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: BGB-11417
Phase: 2
Study Start date:
October 24, 2022
Estimated Completion Date:
August 25, 2027

Connect with a study center

  • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital

    Hefei, Anhui 230088
    China

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University(Tongzhou)

    Beijing, Beijing 101100
    China

    Site Not Available

  • Beijing Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • Beijing Jishuitan Hospital

    Beijing, Beijing 100003
    China

    Site Not Available

  • Beijing Jishutan Hospital

    Beijing, Beijing 100003
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing 100000
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • Quanzhou First Affliated Hospital of Fujian Medical University

    Quanzhou, Fujian 362000
    China

    Site Not Available

  • The Second Affiliated Hospital of Fujian Medical University Donghai Campus

    Quanzhou, Fujian 362018
    China

    Site Not Available

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, Fujian 363000
    China

    Site Not Available

  • Lanzhou University Second Hospital

    Lanzhou, Gansu 730030
    China

    Site Not Available

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Yuebei Peoples Hospital

    Shaoguan, Guangdong 512000
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Red Cross Hospital of Yulin City

    Yulin, Guangxi 537000
    China

    Site Not Available

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou 550004
    China

    Site Not Available

  • Hainan Cancer Hospital

    Haikou, Hainan 570312
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan 471003
    China

    Site Not Available

  • Nanyang Central Hospital

    Nanyang, Henan 473000
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 010050
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • Affiliated Hospital of Jiangnan University South Campus

    Wuxi, Jiangsu 214122
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • Northern Jiangsu Peoples Hospital

    Yangzhou, Jiangsu 225001
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • Tonghua Center Hospital

    Tonghua, Jilin 134099
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110004
    China

    Site Not Available

  • Shaanxi Provincial Peoples Hospital

    Xian, Shaanxi 710068
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan, Shandong 250021
    China

    Site Not Available

  • Jining No Peoples Hospital

    Jining, Shandong 272000
    China

    Active - Recruiting

  • Jining No Peoples Hospital West Branch

    Jining, Shandong 272000
    China

    Site Not Available

  • Yantai Yuhuangding Hospital

    Yantai, Shandong 264000
    China

    Site Not Available

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • The Third Peoples Hospital of Datong

    Datong, Shanxi 037008
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi 030032
    China

    Site Not Available

  • Dazhou Central Hospital

    Dazhou, Sichuan 635099
    China

    Site Not Available

  • Peoples Hospital of Deyang City

    Deyang, Sichuan 618000
    China

    Site Not Available

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin 300020
    China

    Site Not Available

  • The First Peoples Hospital of Kashgar

    Kashgar, Xinjiang 844099
    China

    Site Not Available

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Urumqi, Xinjiang 830000
    China

    Site Not Available

  • Yunnan Cancer Hospital

    Kunming, Yunnan 650100
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

  • Ningbo First Hospital

    Ningbo, Zhejiang 315010
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.