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New pill shows promise for Hard-to-Treat blood cancers

NCT ID NCT05479994

Disease control Sponsor: BeiGene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests an oral drug called sonrotoclax (BGB-11417) in 100 adults with chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back or stopped responding to prior treatments. The goal is to see if the drug can shrink or control the cancer. It is not expected to be a cure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sonrotoclax (BGB-11417), a BCL2 inhibitor taken orally
What this could lead to
If successful, this could offer a new treatment option for people with CLL or SLL whose cancer has returned or stopped responding to other therapies.
What could go wrong
This is a mid-stage trial with only 100 participants, so results may not apply to everyone. The drug may not work well or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

100 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia chronic lymphocytic leukemia/small lymphocytic lymphoma leukemia lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leukemia Lymphoma Refractory chronic lymphocytic leukemia/small lymphocytic lymphoma Relapsed chronic lymphocytic leukemia Small lymphocytic lymphoma

Contacts and locations

Locations

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000, China

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004, China

  • Affiliated Hospital of Jiangnan University South Campus

    Wuxi, Jiangsu, 214122, China

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032, China

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

    Hefei, Anhui, 230088, China

  • Beijing Friendship Hospital, Capital Medical University(Tongzhou)

    Beijing, Beijing Municipality, 101100, China

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730, China

  • Beijing Jishuitan Hospital

    Beijing, Beijing Municipality, 100003, China

  • Dazhou Central Hospital

    Dazhou, Sichuan, 635099, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Hainan Cancer Hospital

    Haikou, Hainan, 570312, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin Municipality, 300020, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Jining No Peoples Hospital West Branch

    Jining, Shandong, 272000, China

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030, China

  • Nanyang Central Hospital

    Nanyang, Henan, 473000, China

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010, China

  • Northern Jiangsu Peoples Hospital

    Yangzhou, Jiangsu, 225001, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000, China

  • Peoples Hospital of Deyang City

    Deyang, Sichuan, 618000, China

  • Quanzhou First Affliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000, China

  • Red Cross Hospital of Yulin City

    Yulin, Guangxi, 537000, China

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

  • Shaanxi Provincial Peoples Hospital

    Xi'an, Shaanxi, 710068, China

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021, China

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032, China

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004, China

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010050, China

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021, China

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

    Luoyang, Henan, 471003, China

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The First Peoples Hospital of Kashgar

    Kashgar, Xinjiang, 844099, China

  • The Second Affiliated Hospital of Fujian Medical University Donghai Campus

    Quanzhou, Fujian, 362018, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011, China

  • The Third Peoples Hospital of Datong

    Datong, Shanxi, 037008, China

  • Tonghua Center Hospital

    Tonghua, Jilin, 134099, China

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

    Wuhan, Hubei, 430030, China

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000, China

  • Yuebei Peoples Hospital

    Shaoguan, Guangdong, 512000, China

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650100, China

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, Fujian, 363000, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.