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New hope for lymphoma patients: drug combo trial launches

NCT ID NCT07208981

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 two different drug combinations for people newly diagnosed with marginal zone lymphoma, a slow-growing blood cancer. One group gets a new targeted therapy (orelabrutinib) plus two other drugs, while the other gets standard chemo-immunotherapy. The goal is to see which works better at controlling the disease for longer. About 169 adults aged 18-75 will take part.

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 169 people

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

Started

Aug 2025

Expected to finish

Jun 2031

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 to 75 years

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 18-75 years, gender not restricted; * 2\. Histopathologically confirmed CD20-positive marginal zone lymphoma includes MALT, SMZL, and NMZL; at least one measurable lesion; * 3\. Indication for treatment * 3.1. Initial diagnosis II 2 or IIE or IV stage gastric MALT treatment indications. Including: ① Meeting the inclusion criteria for clinical trials; ② Presence of lymphoma-related clinical symptoms; ③ Gastrointestinal bleeding (bleeding condition controlled or assessed by the investigator for suitability of inclusion); ④ End-organ damage; ⑤ Large mass; ⑥ Persistent or rapid disease progression; ⑦ Patient's willingness; * 3.2. Recommendations for treatment indications of newly diagnosed stage III-IV non-gastric MALT and NMZL. The GELF criteria, similar to those used for follicular lymphoma, include: ① The presence of ≥3 distinct regions of involved lymph nodes, with each involved lymph node having a diameter of ≥3 cm; ② The presence of any lymph node or extranodal lesion with a diameter \>7 cm; ③ The presence of B symptoms; ④ Splenomegaly; ⑤ Symptoms of organ compression, pleural or peritoneal effusion; ⑥ Cytopenia caused by the disease; ⑦ Persistent or rapid disease progression, with tumor size increasing by 20%-30% within 2-3 months or approximately 50% within 6 months; ⑧ Meeting the inclusion criteria for clinical trials; * 3.3. Recommended indications for the treatment of newly diagnosed SMZL. Including: ① Progressive or painful splenomegaly; ② Symptomatic or progressive cytopenia such as HB\<100g/L, PLT\<80×10\^9/L, absolute neutrophil count (ANC)\<1.0×10\^9/L (note to differentiate from cytopenia caused by autoimmune factors); * 4\. Without prior systemic treatment, may include MZL (marginal zone lymphoma) that has progressed, relapsed, or is unsuitable for local treatment after previous local therapy (local treatment includes surgery, radiotherapy, anti-Helicobacter pylori therapy for at least 12 months, or anti-hepatitis C therapy); * 5\. ECOG performance status score 0-2 points * 6\. The main organ functions meet the following criteria (except for SMZL, which is judged separately by the investigator to meet treatment requirements): Complete blood count: Absolute neutrophil count ≥1.5×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow involvement, absolute neutrophil count ≥1.0×10\^9/L, platelets ≥50×10\^9/L, hemoglobin ≥50g/L; Blood biochemistry: Total bilirubin ≤ 1.5 times ULN, AST or ALT ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; serum amylase ≤ ULN; creatinine clearance rate ≥ 60 mL/min; * 7\. Coagulation function: International Normalized Ratio (INR) ≤1.5 times ULN; * 8\. Expected survival time ≥ 12 months; * 9\. Voluntarily sign a written informed consent before trial screening. Exclusion Criteria: * 1\. Currently or previously diagnosed with other malignancies, unless radical treatment has been performed and there is evidence of no recurrence or metastasis within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, and localized squamous cell carcinoma of the skin; * 2\. Lymphoma involving the central nervous system or transforming to a higher grade; * 3\. Uncontrolled or significant cardiovascular diseases, including: a) Occurrence of New York Heart Association (NYHA) Class III-IV congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first administration of the investigational drug, or the presence of treatable arrhythmias at screening, with left ventricular ejection fraction (LVEF) \<50%; b) Primary cardiomyopathies (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy); c) A clinically significant history of QTc interval prolongation, or QTc interval during the screening period \>470ms for females and \>450ms for males; d) Subjects with symptomatic or medication-requiring coronary heart disease; e) Suffering from uncontrolled hypertension (blood pressure remains uncontrolled after more than one month of using a reasonable and tolerable dosage of three or more antihypertensive drugs (including diuretics) based on lifestyle improvements, or blood pressure can only be effectively controlled by taking four or more antihypertensive drugs); * 4\. Active bleeding within 2 months prior to screening, or currently taking anticoagulants, or deemed by the investigator to have a clear bleeding tendency; * 5\. History of deep vein thrombosis or pulmonary embolism in the past six months; * 6\. Underwent major surgery within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening. Major surgery refers to procedures performed under general anesthesia, but endoscopic examinations for diagnostic purposes are not considered major surgery. The insertion of vascular access devices is exempt from this exclusion criterion; * 7\. Active infection or uncontrolled HBV (HBsAg positive and/or HBcAb positive with HBV DNA titer positive), HCV RNA positive, HIV/AIDS, or other severe infectious diseases; * 8\. Currently, there are subjects with severe pulmonary function impairment due to conditions such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, and drug-related pneumonia: FEV1% or DLCO (or DLCO/VA) %pred \< 40% (with severe pulmonary ventilation and gas exchange dysfunction); * 9\. Pregnant, lactating women and childbearing age subjects unwilling to use contraception; * 10\. Need to continuously take medications with moderate to strong inhibitory or strong inducing effects on cytochrome P450 CYP3A; * 11\. The investigator considers other conditions unsuitable for participating in this trial.

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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.

How to take part

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

  1. The places running it

    1 site. 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

  • The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

More trials for these conditions

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