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Targeted drug shows promise for Hard-to-Treat lymphoma

NCT ID NCT05068440

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested the drug zanubrutinib in 65 adults with a specific genetic form (CD79B mutant) of relapsed or refractory diffuse large B-cell lymphoma, an aggressive blood cancer. Participants took zanubrutinib capsules twice daily and were monitored for tumor response and side effects. The goal was to see if this targeted therapy could shrink or control the cancer when standard treatments have failed.

What this could mean

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

Active substance
zanubrutinib (a targeted cancer drug taken as capsules)
What this could lead to
If successful, this could provide a new treatment option for people with a specific genetic subtype of aggressive lymphoma that has not responded to standard therapy.
What could go wrong
This is a small, single-arm Phase 2 study with no comparison group, so results may not be definitive. The drug may not work for all patients and 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

65 people

The number who actually took part.

Started

Aug 2021

Finished

Mar 2025

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.

Inclusion Criteria 1. Participants had histologically confirmed diffuse large B-cell lymphoma, based on the World Health Organization 2008 classification of tumors of hematopoietic and lymphoid tissue. 2. Participants had a positive CD79B gene mutation, as confirmed by a central laboratory. 3. Participants had previously received at least one line of adequate systemic therapy for diffuse large B-cell lymphoma, defined as anti-CD20 antibody-based chemoimmunotherapy administered for at least two consecutive cycles, unless disease progression occurred before completion of Cycle 2. 4. Participants had relapsed or refractory disease prior to study entry, defined as either: 1. Recurrent disease after achieving disease remission, defined as a complete response or partial response, at the completion of the most recent treatment regimen; or 2. Stable disease or progressive disease at the completion of the most recent treatment regimen. 5. Participants were ineligible for high-dose therapy and stem cell transplantation, defined as meeting at least one of the following criteria: a. Presence of significant organ dysfunction, such as: 1. Left ventricular ejection fraction less than 50 percent as measured by echocardiogram or multiple gated acquisition scan; 2. Diffusing capacity of the lung for carbon monoxide less than 60 percent of the predicted value as measured by pulmonary function testing; or 3. Creatinine clearance less than 70 milliliters per minute as demonstrated by nuclear medicine scan or 24-hour urine collection; or comorbid conditions that precluded the use of high-dose therapy and stem cell transplantation due to an unacceptable risk of treatment-related morbidity. b. Failure to achieve a complete response or partial response following salvage therapy. c. Failure to collect stem cells or inability to undergo stem cell collection, as assessed by the investigator. Exclusion Criteria 1. Participants had non-Hodgkin lymphoma other than classical histology diffuse large B-cell lymphoma (not otherwise specified), including but not limited to: 1. Diffuse large B-cell lymphoma transformed from indolent lymphomas 2. Primary mediastinal (thymic) large B-cell lymphoma 3. Primary cutaneous diffuse large B-cell lymphoma 4. Primary effusion lymphoma 5. Central nervous system lymphoma 2. Participants had a history of allogeneic stem cell transplantation or chimeric antigen receptor T-cell therapy. 3. Participants had prior exposure to a Bruton's tyrosine kinase inhibitor. 4. Participants had received any of the following treatments within the specified timeframe prior to the first dose of study drug: 1. Corticosteroids administered with antineoplastic intent within two weeks prior to study treatment. A short course (seven days or fewer) of systemic corticosteroids at doses of 20 milligrams per day or less of prednisone equivalent for control of lymphoma-related symptoms was permitted prior to enrollment, provided the corticosteroids were tapered off within five days after initiation of study treatment. 2. Chemotherapy or radiotherapy within two weeks. 3. Monoclonal antibody therapy within two weeks. 4. Investigational therapy within two weeks. 5. Chinese patent medicine administered with antineoplastic intent within two weeks. 5. Participants had a history of other active malignancies within two years prior to study entry, with the exception of: 1. Adequately treated carcinoma in situ of the cervix; 2. Localized basal cell carcinoma or squamous cell carcinoma of the skin; or 3. A previous malignancy that was confined and treated locally (by surgery or other modality) with curative intent. Note: Other protocol-defined inclusion and exclusion criteria may have applied.

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

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

Refractory diffuse large B-cell lymphoma Relapsed diffuse large B cell lymphoma

Contacts and locations

Locations

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

    Hefei, Anhui, 230088, China

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Guangdong Provincial Peoples Hospital Huifu Branch

    Guangzhou, Guangdong, 510120, China

  • Hainan Cancer Hospital

    Haikou, Hainan, 570312, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000, 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

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042, China

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013, China

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • Taizhou Hospital of Zhejiang

    Taizhou, Zhejiang, 317000, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120, China

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong, 515041, 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 Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011, China

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

    Wuhan, Hubei, 430030, China

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

    Wuhan, Hubei, 430022, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650100, China

  • Zhejiang University College of Medicine Second Affiliated Hospital

    Hangzhou, Zhejiang, 310009, China

More trials for these conditions

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