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New pill shows promise for rare lymphoma – no chemo needed yet

NCT ID NCT07441993

Disease control Sponsor: Institute of Hematology & Blood Diseases Hospital, China 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 drug called orelabrutinib in 30 people with a slow-growing blood cancer called marginal zone lymphoma who have not had any prior treatment. The goal is to see if the drug can shrink or control the cancer. Participants take the drug by mouth and are monitored for side effects and how well the cancer responds.

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 30 people

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

Started

Jan 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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, regardless of gender; 2. Patients with histopathologically confirmed stage I/II marginal zone lymphoma; 3. ECOG performance status score of 0-2; 4. Major organ functions meeting the following criteria: 1. Blood tests: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow involvement, ANC ≥1.0×10\^9/L, platelets ≥50×10\^9/L, hemoglobin ≥50g/L; 2. Blood biochemistry: Total bilirubin ≤1.5×ULN, AST or ALT ≤2×ULN; serum creatinine ≤1.5×ULN; 5. Coagulation function: International normalized ratio (INR) ≤1.5×ULN; 6. Expected survival time ≥12 months; 7. Voluntary written informed consent signed before trial screening. Exclusion Criteria: 1. Lymphoma involving the central nervous system or transformation to high-grade; 2. Uncontrolled or significant cardiovascular diseases, including: 1. New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first dose of the study drug, or arrhythmia requiring treatment at screening, with left ventricular ejection fraction (LVEF) \<50%; 2. Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, or unclassified cardiomyopathy); 3. History of clinically significant QTc interval prolongation, or QTc interval \>470 ms for females or \>450 ms for males at screening; 4. Subjects with symptomatic coronary artery disease requiring medication; 5. Poorly controlled hypertension (failure to achieve target blood pressure after at least one month of lifestyle modification and treatment with three or more antihypertensive drugs, including diuretics, at maximally tolerated doses, or requiring four or more antihypertensive drugs for effective control). 3. Active bleeding within 2 months prior to screening, or current use of anticoagulants, or investigator-determined clear bleeding tendency; 4. History of deep vein thrombosis or pulmonary embolism within the past six months; 5. Urine protein ≥2+ and 24-hour urine protein quantification ≥2 g/24 hours; 6. Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or subjects with total gastrectomy; 7. Current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or other conditions affecting lung function; 8. Pregnant or breastfeeding women, or subjects of childbearing potential unwilling to use contraception; 9. Continuous use of drugs with moderate to strong cytochrome P450 CYP3A inhibition or strong induction effects; 10. Other conditions deemed by the investigator as unsuitable for participation in this trial.

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Conditions

The condition(s) this trial relates to.

lymphoma 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.

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

    14 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 Hospital of Nantong University

    RECRUITING

    Nantong, Jiangsu, China

  • Beijing Tongren Hospital, Capital Medical University

    RECRUITING

    Beijing, China

  • Hematology Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Tianjin, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Jiangsu Province People's Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • Nanfang Hospital, Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, China

  • Shandong Cancer Hospital & Institute

    RECRUITING

    Jinan, Shandong, China

  • Shandong Provincial Hospital

    RECRUITING

    Jinan, Shandong, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • The First Bethune Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, China

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, China

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

    RECRUITING

    Wuhan, Hubei, China

  • Xiangyang Central Hospital

    RECRUITING

    Xiangyang, Hubei, China

More trials for these conditions

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