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

Primary Purpose

Leukemia, Lymphoma, Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
BGB-11417
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Refractory Chronic Lymphocytic Leukemia, Leukemia, Lymphoma, Small Lymphocytic Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 patients as assessed by the investigator (eg, patients with del[17p]/TP53).
  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

Sites / Locations

  • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province HospitalRecruiting
  • Peking University Third HospitalRecruiting
  • Beijing Jishutan HospitalRecruiting
  • Beijing HospitalRecruiting
  • Beijing Friendship Hospital, Capital Medical University(Tongzhou)Recruiting
  • Fujian Cancer HospitalRecruiting
  • Quanzhou First Affliated Hospital of Fujian Medical UniversityRecruiting
  • The Second Affiliated Hospital of Fujian Medical University Donghai CampusRecruiting
  • Zhangzhou Municipal Hospital of Fujian ProvinceRecruiting
  • Lanzhou University Second HospitalRecruiting
  • Zhujiang Hospital of Southern Medical UniversityRecruiting
  • Yuebei Peoples HospitalRecruiting
  • The First Affiliated Hospital of Guangxi Medical UniversityRecruiting
  • Affiliated Hospital of Guizhou Medical UniversityRecruiting
  • Hainan Cancer HospitalRecruiting
  • The First Affiliated Hospital of Henan University of Science and TechnologyRecruiting
  • Nanyang Central HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • Tongji Hospital of Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • Hunan Cancer HospitalRecruiting
  • The Affiliated Hospital of Inner Mongolia Medical UniversityRecruiting
  • Zhongda Hospital Southeast UniversityRecruiting
  • Jiangsu Province HospitalRecruiting
  • Affiliated Hospital of Jiangnan University South CampusRecruiting
  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
  • Northern Jiangsu Peoples HospitalRecruiting
  • The First Affiliated Hospital of Nanchang University Branch DonghuRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • Shaanxi Provincial Peoples HospitalRecruiting
  • Shandong Provincial HospitalRecruiting
  • Shandong Cancer HospitalRecruiting
  • Jining No Peoples HospitalRecruiting
  • Yantai Yuhuangding HospitalRecruiting
  • Rui Jin Hospital Shanghai Jiao Tong University School of MedicineRecruiting
  • Affiliated Zhongshan Hospital of Fudan UniversityRecruiting
  • The Third Peoples Hospital of DatongRecruiting
  • Shanxi Bethune HospitalRecruiting
  • Institute of Hematology and Hospital of Blood DiseaseRecruiting
  • The First Peoples Hospital of KashgarRecruiting
  • Affiliated Cancer Hospital of Xinjiang Medical UniversityRecruiting
  • Yunnan Cancer HospitalRecruiting
  • The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Ningbo First HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Participants will receive BGB-11417 orally until disease progression, intolerable toxicity, or other scenarios specified in the protocol

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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
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.
Time to Response (TTR) as assessed by investigator and IRC
TTR is defined as the time from treatment initiation to the first documented response.
Overall Survival (OS)
defined as time from the start of treatment to the date of death due to any cause
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).
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.
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
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
Number of participants with clinically significant changes from baseline in clinical laboratory values
Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
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

Full Information

First Posted
July 27, 2022
Last Updated
August 23, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT05479994
Brief Title
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 Bcl-2 Inhibitor BGB-11417 in Adult Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
September 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Participants will receive BGB-11417 orally until disease progression, intolerable toxicity, or other scenarios specified in the protocol
Intervention Type
Drug
Intervention Name(s)
BGB-11417
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
Description
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)
Time Frame
Up to 2 Years
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR) as assessed by the investigator
Description
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)
Time Frame
Up to 2 Years
Title
Duration of response (DoR) as determined by the IRC and the investigator
Description
DoR is defined as the time from first determination of response until first documentation of progression or death, whichever occurs first
Time Frame
Up to 5 Years
Title
Progression Free Survival (PFS) as determined by the IRC and the investigator
Description
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.
Time Frame
Up to 5 Years
Title
Time to Response (TTR) as assessed by investigator and IRC
Description
TTR is defined as the time from treatment initiation to the first documented response.
Time Frame
Up to 2 Years
Title
Overall Survival (OS)
Description
defined as time from the start of treatment to the date of death due to any cause
Time Frame
Up to 5 Years
Title
Participants Reported Outcome as measured by EQ-5D-5L questionnaires
Description
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).
Time Frame
Up to 5 Years
Title
Participant Reported Outcomes as measured by NFLymSI-18
Description
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.
Time Frame
Up to 5 Years
Title
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
with adverse events leading to discontinuation, and AEs graded according NCI-CTCAE Version 5 and the Grading Scale for Hematologic Toxicity in CLL Studies
Time Frame
Up to 5 Years
Title
Number of participants with clinically significant changes from baseline in vital signs
Description
Vital signs include systolic and diastolic blood pressure, heart rate, and body temperature
Time Frame
Up to 5 Years
Title
Number of participants with clinically significant changes from baseline in clinical laboratory values
Description
Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
Time Frame
Up to 5 Years
Title
Number of Participants With Clinically Significant Physical Examination Findings
Description
A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems
Time Frame
Up to 5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria Participants with a histologically confirmed diagnosis of CLL/SLL based on the International Workshop on CLL (iwCLL) criteria: Treatment intolerance or failure during or after treatment with chemoimmunotherapy (CIT) and BTK inhibitors (BTKi) or Treatment intolerance or failure during or after treatment with BTKi for CIT-ineligible patients as assessed by the investigator (eg, patients with del[17p]/TP53). Participants who require treatment based on the iwCLL 2018 criteria Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2 Life expectancy of > 6 month Key Exclusion Criteria 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 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 A known history of or currently suspected Richter's syndrome Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or prior chimeric cell therapy (unless ≥ 6 months after cell infusion) Prior allogeneic stem cell transplant Note: Other protocol defined Inclusion/Exclusion criteria may apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BeiGene
Phone
1.877.828.5568
Email
clinicaltrials@beigene.com
Facility Information:
Facility Name
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230088
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Jishutan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100003
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Friendship Hospital, Capital Medical University(Tongzhou)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101100
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Name
Quanzhou First Affliated Hospital of Fujian Medical University
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362000
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Fujian Medical University Donghai Campus
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362018
Country
China
Individual Site Status
Recruiting
Facility Name
Zhangzhou Municipal Hospital of Fujian Province
City
Zhangzhou
State/Province
Fujian
ZIP/Postal Code
363000
Country
China
Individual Site Status
Recruiting
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Individual Site Status
Recruiting
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Name
Yuebei Peoples Hospital
City
Shaoguan
State/Province
Guangdong
ZIP/Postal Code
512000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550004
Country
China
Individual Site Status
Recruiting
Facility Name
Hainan Cancer Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570312
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Individual Site Status
Recruiting
Facility Name
Nanyang Central Hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473000
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010050
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Jiangnan University South Campus
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214122
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Name
Northern Jiangsu Peoples Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanchang University Branch Donghu
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Name
Shaanxi Provincial Peoples Hospital
City
Xian
State/Province
Shaanxi
ZIP/Postal Code
710068
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Name
Jining No Peoples Hospital
City
Jining
State/Province
Shandong
ZIP/Postal Code
272000
Country
China
Individual Site Status
Recruiting
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Individual Site Status
Recruiting
Facility Name
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Zhongshan Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Peoples Hospital of Datong
City
Datong
State/Province
Shanxi
ZIP/Postal Code
037008
Country
China
Individual Site Status
Recruiting
Facility Name
Shanxi Bethune Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030032
Country
China
Individual Site Status
Recruiting
Facility Name
Institute of Hematology and Hospital of Blood Disease
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Name
The First Peoples Hospital of Kashgar
City
Kashgar
State/Province
Xinjiang
ZIP/Postal Code
844099
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Cancer Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Individual Site Status
Recruiting
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650100
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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