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New hope for lymphoma patients: drug combo trial launches

NCT ID NCT06082102

Disease control Sponsor: Beijing InnoCare Pharma Tech Co., 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether a combination of orelabrutinib and rituximab works better than lenalidomide plus rituximab for people with marginal zone lymphoma that has come back or not responded to treatment. About 324 adults will be randomly assigned to one of the two treatment groups. The main goal is to see how long the cancer stays under control.

What this could mean

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

Active substance
Orelabrutinib and rituximab
What this could lead to
If successful, this could offer a new, more effective treatment option for people with marginal zone lymphoma that has returned or not responded to prior therapy.
What could go wrong
This is a phase 3 trial, but results are not yet known. The experimental combination may not prove better than the standard combination, and side effects like infections or blood cell changes are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 324 people

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

Started

Dec 2023

Expected to finish

Feb 2030

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 , either sex. 2. Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal). 3. Prior systemic therapy including at least one anti-CD20 monoclonal antibody-containing regimen is required, with the following specifications: For combination therapies: Minimum of 2 completed treatment cycles For anti-CD20 monotherapy: Minimum of 4 administered doses Progression during treatment waives cycle/dose requirements 4. Relapsed or refractory disease. 5. At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI). 6. ECOG performance status (PS) score of 0-2. Exclusion Criteria: 1. Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment. 2. Administration of any other investigational product within 4 weeks prior to the first dose of the study treatment, or concurrent participation in another clinical trial.(Excluding patients who have discontinued treatment and are in long-term follow-up). 3. Prior treatment with any types of BTK inhibitor. 4. Patients refractory to lenalidomide plus rituximab (R2 regimen). Refractoriness is defined as either: Failure to achieve at least partial response (PR) after completing an adequate R2 treatment course (≥2 cycles at standard doses), OR Disease progression during R2 therapy or within 6 months after the last dose. 5. Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.

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Conditions

The condition(s) this trial relates to.

Lymphoma, B-Cell, Marginal Zone marginal zone lymphoma

As listed by the trial registrant

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

Relapsed/refractory marginal zone lymphoma

How to take part

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

  1. The places running it

    19 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

  • Beijing Tiantan Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100070, China

  • Beijing Tongren Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

  • Guangdong Provincial Hospital of Chinese Medicine

    RECRUITING

    Guangzhou, Guangdong, 510120, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Henan Provincial Peoples Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Hunan Cancer Hospital

    NOT_YET_RECRUITING

    Changsha, Hunan, 410000, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, Jiangxi, 330029, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510055, China

  • The Affiliated Hospital Of Qingdao University

    NOT_YET_RECRUITING

    Qingdao, Shandong, 266000, China

  • The First Affiliated Hospital of Bengbu Medical College

    RECRUITING

    Bengbu, Auhui, 233000, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital）

    RECRUITING

    Xi’an, Shanxi, 710004, China

  • The Second Hospital of Dalian Medical University

    RECRUITING

    Dalian, Liaoning, 116023, China

  • The first Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110002, China

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

    RECRUITING

    Wuhan, Hubei, 430000, China

  • West China Hospital, Sichuan University

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610041, China

  • Yantai Yuhuangding Hospital

    RECRUITING

    Yantai, Shandong, 264099, China

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