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

NCT ID: NCT05479994

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-24

Study Completion Date

2027-08-25

Brief Summary

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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)

Detailed Description

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Conditions

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Leukemia Lymphoma Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Small Lymphocytic Lymphoma Relapsed Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm

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

Group Type EXPERIMENTAL

BGB-11417

Intervention Type DRUG

Administered orally

Interventions

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BGB-11417

Administered orally

Intervention Type DRUG

Other Intervention Names

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sonrotoclax

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BeiGene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital

Hefei, Anhui, China

Site Status

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Friendship Hospital, Capital Medical University(Tongzhou)

Beijing, Beijing Municipality, China

Site Status

Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status

Quanzhou First Affliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

Site Status

The Second Affiliated Hospital of Fujian Medical University Donghai Campus

Quanzhou, Fujian, China

Site Status

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, China

Site Status

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Site Status

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status

Yuebei Peoples Hospital

Shaoguan, Guangdong, China

Site Status

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status

Red Cross Hospital of Yulin City

Yulin, Guangxi, China

Site Status

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Site Status

Hainan Cancer Hospital

Haikou, Hainan, China

Site Status

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Site Status

Nanyang Central Hospital

Nanyang, Henan, China

Site Status

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status

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

Wuhan, Hubei, China

Site Status

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Site Status

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Site Status

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status

Affiliated Hospital of Jiangnan University South Campus

Wuxi, Jiangsu, China

Site Status

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status

Northern Jiangsu Peoples Hospital

Yangzhou, Jiangsu, China

Site Status

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, China

Site Status

The First Hospital of Jilin University

Changchun, Jilin, China

Site Status

Tonghua Center Hospital

Tonghua, Jilin, China

Site Status

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Shaanxi Provincial Peoples Hospital

Xi'an, Shaanxi, China

Site Status

Shandong Provincial Hospital

Jinan, Shandong, China

Site Status

Shandong Cancer Hospital

Jinan, Shandong, China

Site Status

Jining No Peoples Hospital West Branch

Jining, Shandong, China

Site Status

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Site Status

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

The Third Peoples Hospital of Datong

Datong, Shanxi, China

Site Status

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Site Status

Dazhou Central Hospital

Dazhou, Sichuan, China

Site Status

Peoples Hospital of Deyang City

Deyang, Sichuan, China

Site Status

Institute of Hematology and Hospital of Blood Disease

Tianjin, Tianjin Municipality, China

Site Status

The First Peoples Hospital of Kashgar

Kashgar, Xinjiang, China

Site Status

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

Yunnan Cancer Hospital

Kunming, Yunnan, China

Site Status

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

Ningbo First Hospital

Ningbo, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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CTR20222085

Identifier Type: OTHER

Identifier Source: secondary_id

BGB-11417-202

Identifier Type: -

Identifier Source: org_study_id

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