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

A 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

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)

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; Leukemia; Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Relapsed Chronic Lymphocytic Leukemia
• Intervention / Treatment: Drug: BGB-11417

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: BeiGene; Phone Number: 1.877.828.5568; Email: clinicaltrials@beigene.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230088
      • Recruiting
      • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Beijing Hospital
    • Beijing, Beijing, China, 101100
      • Recruiting
      • Beijing Friendship Hospital, Capital Medical University(Tongzhou)
    • Beijing, Beijing, China, 100003
      • Recruiting
      • Beijing Jishuitan hospital
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Cancer Hospital
    • Quanzhou, Fujian, China, 362000
      • Recruiting
      • Quanzhou First Affliated Hospital of Fujian Medical University
    • Quanzhou, Fujian, China, 362018
      • Recruiting
      • The Second Affiliated Hospital of Fujian Medical University Donghai Campus
    • Zhangzhou, Fujian, China, 363000
      • Recruiting
      • Zhangzhou Municipal Hospital of Fujian Province
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Recruiting
      • Lanzhou University Second Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Zhujiang Hospital of Southern Medical University
    • Shaoguan, Guangdong, China, 512000
      • Recruiting
      • Yuebei Peoples Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Recruiting
      • The First Affiliated Hospital of Guangxi Medical University
  • Guizhou
    • Guiyang, Guizhou, China, 550004
      • Recruiting
      • Affiliated Hospital of Guizhou Medical University
  • Hainan
    • Haikou, Hainan, China, 570312
      • Recruiting
      • Hainan Cancer Hospital
  • Henan
    • Luoyang, Henan, China, 471003
      • Recruiting
      • The First Affiliated Hospital of Henan University of Science and Technology
    • Nanyang, Henan, China, 473000
      • Recruiting
      • Nanyang Central Hospital
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Cancer Hospital
    • Changsha, Hunan, China, 410011
      • Recruiting
      • The Second Xiangya Hospital of Central South University
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 010050
      • Recruiting
      • The Affiliated Hospital of Inner Mongolia Medical University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital Southeast University
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu Province Hospital
    • Wuxi, Jiangsu, China, 214122
      • Recruiting
      • Affiliated Hospital of Jiangnan University South Campus
    • Xuzhou, Jiangsu, China, 221000
      • Recruiting
      • The Affiliated Hospital of Xuzhou Medical University
    • Yangzhou, Jiangsu, China, 225001
      • Recruiting
      • Northern Jiangsu Peoples Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The First Affiliated Hospital of Nanchang University Branch Donghu
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Recruiting
      • Shengjing Hospital of China Medical University
  • Shaanxi
    • Xian, Shaanxi, China, 710068
      • Recruiting
      • Shaanxi Provincial Peoples Hospital
  • Shandong
    • Jinan, Shandong, China, 250021
      • Recruiting
      • Shandong Provincial Hospital
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital
    • Jining, Shandong, China, 272000
      • Recruiting
      • Jining No Peoples Hospital
    • Yantai, Shandong, China, 264000
      • Recruiting
      • Yantai Yuhuangding Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Affiliated Zhongshan Hospital of Fudan University
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
  • Shanxi
    • Datong, Shanxi, China, 037008
      • Recruiting
      • The Third Peoples Hospital of Datong
    • Taiyuan, Shanxi, China, 030032
      • Recruiting
      • Shanxi Bethune Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300020
      • Recruiting
      • Institute of Hematology and Hospital of Blood Disease
  • Xinjiang
    • Kashgar, Xinjiang, China, 844099
      • Recruiting
      • The First Peoples Hospital of Kashgar
    • Urumqi, Xinjiang, China, 830000
      • Recruiting
      • Affiliated Cancer Hospital of Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China, 650100
      • Recruiting
      • Yunnan Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The first affiliated hospital, Zhejiang university school of medicine
    • Ningbo, Zhejiang, China, 315010
      • Recruiting
      • Ningbo First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Participants will receive BGB-11417 orally until disease progression, intolerable toxicity, or other scenarios specified in the protocol	Drug: BGB-11417; Administered orally; Other Names: sonrotoclax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 patients with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for patients with small lymphocytic lymphoma (SLL)	Up to 2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR) as assessed by the investigator	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 patients with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for patients with small lymphocytic lymphoma (SLL)	Up to 2 Years
Duration of response (DoR) as determined by the IRC and the investigator	DoR is defined as the time from first determination of response until first documentation of progression or death, whichever occurs first	Up to 5 Years
Progression Free Survival (PFS) as determined by the IRC and the investigator	PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurs first.	Up to 5 Years
Time to Response (TTR) as assessed by investigator and IRC	TTR is defined as the time from treatment initiation to the first documented response.	Up to 2 Years
Overall Survival (OS)	defined as time from the start of treatment to the date of death due to any cause	Up to 5 Years
Participants Reported Outcome as measured by EQ-5D-5L questionnaires	The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to).	Up to 5 Years
Participant Reported Outcomes as measured by NFLymSI-18	The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score.	Up to 5 Years
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	with adverse events leading to discontinuation, and AEs graded according NCI-CTCAE Version 5 and the Grading Scale for Hematologic Toxicity in CLL Studies	Up to 5 Years
Number of participants with clinically significant changes from baseline in vital signs	Vital signs include systolic and diastolic blood pressure, heart rate, and body temperature	Up to 5 Years
Number of participants with clinically significant changes from baseline in clinical laboratory values	Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis	Up to 5 Years
Number of Participants With Clinically Significant Physical Examination Findings	A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems	Up to 5 Years

Collaborators and Investigators

• Sponsor: BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2022
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): September 15, 2027

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Lymphoma; Leukemia; Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Leukemia, B-Cell; Chronic Disease; Lymphoma; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: BGB-11417-202; CTR20222085 (Other Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No