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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05479994
• Other study ID #: BGB-11417-202
• Secondary ID: CTR20222085
• Status: Recruiting
• Phase: Phase 2
• Start date: October 24, 2022
• Est. completion date: August 25, 2027

Study information

• Verified date: May 2024
• Source: BeiGene
• Contact: BeiGene
• Phone: 1.877.828.5568
• Email: clinicaltrials[@]beigene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 97
• Est. completion date: August 25, 2027
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Relapsed Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Intervention

Drug:
• BGB-11417
Administered orally

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University(Tongzhou)	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Peoples Hospital of Datong	Datong	Shanxi
China	Dazhou Central Hospital	Dazhou	Sichuan
China	Peoples Hospital of Deyang City	Deyang	Sichuan
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital	Hefei	Anhui
China	Shandong Provincial Hospital	Jinan	Shandong
China	Jining No Peoples Hospital	Jining	Shandong
China	The First Peoples Hospital of Kashgar	Kashgar	Xinjiang
China	Yunnan Cancer Hospital	Kunming	Yunnan
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Nanyang Central Hospital	Nanyang	Henan
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Quanzhou First Affliated Hospital of Fujian Medical University	Quanzhou	Fujian
China	Affiliated Zhongshan Hospital of Fudan University	Shanghai	Shanghai
China	Rui Jin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	Institute of Hematology and Hospital of Blood Disease	Tianjin	Tianjin
China	Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Affiliated Hospital of Jiangnan University South Campus	Wuxi	Jiangsu
China	Shaanxi Provincial Peoples Hospital	Xian	Shaanxi
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Northern Jiangsu Peoples Hospital	Yangzhou	Jiangsu
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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)	Up to 2 Years
Secondary	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 participants with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for participants with small lymphocytic lymphoma (SLL)	Up to 2 Years
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall Survival (OS)	defined as time from the start of treatment to the date of death due to any cause	Up to 5 Years
Secondary	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
Secondary	Participant Reported Outcomes as measured by NFLymSI-18	The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (NFLymSI-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
Secondary	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
Secondary	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
Secondary	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
Secondary	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