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New pill takes on aggressive lymphoma in phase 2 trial

NCT ID NCT07189065

Disease control Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called rocbrutinib alone against standard treatments for a specific, aggressive type of lymphoma (non-GCB DLBCL) that has returned or not responded to prior therapy. About 150 adults will be randomly assigned to receive either rocbrutinib or a standard regimen chosen by their doctor. The main goal is to see if rocbrutinib can shrink tumors better than the standard options.

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

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2028

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.

Inclusion Criteria: 1. Age ≥18 years, any gender. 2. Pathologically confirmed DLBCL (not otherwise specified) according to the revised 2017 WHO classification of lymphoid neoplasms, with non-germinal center B-cell-like (non-GCB) subtype confirmed by Han's algorithm (Appendix 1), based on previous pathological records or confirmed during screening. Must be able to provide sufficient tumor tissue or slides (from previous or screening biopsies) for central laboratory confirmation of pathological diagnosis (if the local pathology report is clear, patients may be enrolled and start treatment without waiting for the central pathology report). 3. Patients who are refractory or have relapsed after at least two prior lines of therapy (at least one line must include an anti-CD20 antibody-containing regimen) (see section 6.3 for definition of refractory or relapsed). 4. At least one measurable lesion (nodal lesion with longest diameter \>1.5 cm, extranodal lesion with longest diameter \>1.0 cm). 5. Not planned for autologous stem cell transplantation (ASCT). 6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2. Exclusion Criteria: 1. Primary central nervous system (CNS) lymphoma or known involvement of lymphoma in the CNS (including patients whose CNS lymphoma is currently in complete remission). 2. DLBCL resulting from histological transformation of an previously diagnosed indolent lymphoma \[such as follicular lymphoma (FL), marginal zone lymphoma, chronic lymphocytic leukemia, etc.\] or pathological findings suggesting concomitant FL (any grade). 3. Diagnosis of other types of large B-cell lymphoma or special types of DLBCL, including but not limited to high-grade B-cell lymphoma, EBV-positive DLBCL, T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal large B-cell lymphoma, etc. 4. Previous exposure to Lobertinib or known allergy to any excipient of Lobertinib (including microcrystalline cellulose, croscarmellose sodium, magnesium stearate, fumaric acid, and gastric-soluble film coating premix); allergy or intolerance to Rituximab or any of its excipients; allergy or intolerance to both Bendamustine and Lenalidomide or any of their excipients. 5. Previous refractoriness to BTK-targeting drugs. 6. Patients who have received autologous stem cell transplantation within 90 days prior to randomization; patients who have received allogeneic stem cell transplantation.

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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.

Diffuse large B-cell lymphoma (DLBCL)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    41 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Cancer Hospital of Guangzhou Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, China

  • Affiliated Tumor Hospital of Guangxi Medical University

    NOT_YET_RECRUITING

    Nanning, Guangxi, China

  • Anhui Cancer Hospital (West Branch of Anhui Provincial Hospital)

    NOT_YET_RECRUITING

    Hefei, Anhui, China

  • Beijing Shijitan Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Beijing Tongren Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Fudan University Shanghai Cancer Center

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, China

  • Fujian Cancer Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, China

  • Guangdong Provincial People's Hospital

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Henan Provincial People's Hospital

    NOT_YET_RECRUITING

    Zhengzhou, Henan, China

  • Hubei Cancer Hospital

    NOT_YET_RECRUITING

    Wuhan, Hubei, China

  • Hunan Cancer Hospital

    NOT_YET_RECRUITING

    Changsha, Hunan, China

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, China

  • Jiangsu Cancer Hospital

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, China

  • Jiangxi Cancer Hospital

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, China

  • Liaoning Cancer Hospital

    NOT_YET_RECRUITING

    Shenyang, Liaoning, China

  • Linyi Cancer Hospital

    NOT_YET_RECRUITING

    Linyi, Shandong, China

  • Meizhou People's Hospital

    NOT_YET_RECRUITING

    Meizhou, Guangdong, China

  • Nanfang Hospital

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, China

  • National Cancer Center/Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, China

  • Peking University Third Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Shanxi Bethune Hospital

    NOT_YET_RECRUITING

    Taiyuan, Shanxi, China

  • Shanxi Province Cancer Hospital

    NOT_YET_RECRUITING

    Taiyuan, Shanxi, China

  • Shengjing Hospital of China Medical University

    NOT_YET_RECRUITING

    Shenyang, Liaoning, China

  • Sichuan Cancer Hospital

    NOT_YET_RECRUITING

    Chengdu, Sichuan, China

  • The Affiliated Hospital of Xuzhou Medical University

    NOT_YET_RECRUITING

    Xuzhou, Jiangsu, China

  • The First Affiliated Hospital of Chongqing Medical University

    NOT_YET_RECRUITING

    Chongqing, Chongqing Municipality, China

  • The First Affiliated Hospital of Guangxi Medical University

    NOT_YET_RECRUITING

    Nanning, Guangxi, China

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

    NOT_YET_RECRUITING

    Luoyang, Henan, China

  • The First Affiliated Hospital of Nanchang University

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital of Soochow University

    NOT_YET_RECRUITING

    Suzhou, Jiangsu, China

  • The First Affiliated Hospital of Xiamen University

    NOT_YET_RECRUITING

    Xiamen, Hujian, China

  • The First Affiliated Hospital of Zhengzhou University

    NOT_YET_RECRUITING

    Zhengzhou, Henan, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, China

  • The First Hospital of Jilin University

    NOT_YET_RECRUITING

    Jilin City, Jilin, China

  • The Fourth Hospital of Hebei Medical University

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, China

  • The Second Affiliated Hospital of Dalian Medical University

    NOT_YET_RECRUITING

    Dalian, Liaoning, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, China

  • The Second Xiangya Hospital of Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, China

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

    NOT_YET_RECRUITING

    Wuhan, Hubei, China

  • Zhejiang Cancer Hospital

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, China

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