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LeukemiaPhase 2NCT05479994

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

A Phase 2 study testing BGB-11417 in people with Leukemia and Lymphoma, run by BeiGene at 50 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BGB-11417
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
50 sitesChina
Study dates
25 Oct 2022to 25 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 participants as assessed by the investigator.
  • 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

Who cannot join

  • 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

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

China50 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000

  • Beijing Jishuitan Hospital

    Beijing, Beijing Municipality, 100003

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • Beijing Friendship Hospital, Capital Medical University(Tongzhou)

    Beijing, Beijing Municipality, 101100

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • The Third Peoples Hospital of Datong

    Datong, Shanxi, 037008

  • Dazhou Central Hospital

    Dazhou, Sichuan, 635099

  • Peoples Hospital of Deyang City

    Deyang, Sichuan, 618000

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

  • Hainan Cancer Hospital

    Haikou, Hainan, 570312

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

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

    Hefei, Anhui, 230088

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010050

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Jining No Peoples Hospital West Branch

    Jining, Shandong, 272000

  • The First Peoples Hospital of Kashgar

    Kashgar, Xinjiang, 844099

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650100

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

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

    Luoyang, Henan, 471003

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • Nanyang Central Hospital

    Nanyang, Henan, 473000

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010

  • Quanzhou First Affliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000

  • The Second Affiliated Hospital of Fujian Medical University Donghai Campus

    Quanzhou, Fujian, 362018

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Yuebei Peoples Hospital

    Shaoguan, Guangdong, 512000

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin Municipality, 300020

  • Tonghua Center Hospital

    Tonghua, Jilin, 134099

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

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

    Wuhan, Hubei, 430030

  • Affiliated Hospital of Jiangnan University South Campus

    Wuxi, Jiangsu, 214122

  • Shaanxi Provincial Peoples Hospital

    Xi'an, Shaanxi, 710068

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • Northern Jiangsu Peoples Hospital

    Yangzhou, Jiangsu, 225001

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

  • Red Cross Hospital of Yulin City

    Yulin, Guangxi, 537000

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, Fujian, 363000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

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

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)

Being tested
BGB-11417
Keywords
Refractory Chronic Lymphocytic Leukemia, Leukemia, Lymphoma, Small Lymphocytic Lymphoma
Medical subject headings
Leukemia, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGB-11417Drug

    Also called sonrotoclax

    Administered orally

Study groups in NCT05479994
Study groupRoleWhat they receive
Treatment ArmExperimentalParticipants will receive BGB-11417 orally until disease progression, intolerable toxicity, or other scenarios specified in the protocol
Receives: Drug: BGB-11417

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to 2 Years

Secondary outcomes (11)

  1. 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)

    Measured: Up to 2 Years

  2. 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

    Measured: Up to 5 Years

  3. 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.

    Measured: Up to 5 Years

  4. Time to Response (TTR) as assessed by investigator and IRC

    TTR is defined as the time from treatment initiation to the first documented response.

    Measured: Up to 2 Years

  5. Overall Survival (OS)

    defined as time from the start of treatment to the date of death due to any cause

    Measured: Up to 5 Years

  6. 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).

    Measured: Up to 5 Years

  7. 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.

    Measured: Up to 5 Years

  8. 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

    Measured: Up to 5 Years

  9. 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

    Measured: Up to 5 Years

  10. Number of participants with clinically significant changes from baseline in clinical laboratory values

    Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis

    Measured: Up to 5 Years

  11. 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

    Measured: Up to 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2022
  2. Study start25 Oct 2022
  3. Primary completion24 Jan 2025
  4. Study completion25 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05479994
Sponsor's protocol ID
BGB-11417-202
Other IDs
CTR20222085
Status last verified
Mar 2026
First submitted
27 Jul 2022
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BGB-11417 in people with Leukemia and Lymphoma, run by BeiGene at 50 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC) (time frame: Up to 2 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05479994.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.

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