New combo aims to shrink MALT lymphoma with less radiation damage
NCT ID NCT07554898
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing a new approach for adults with stage I-II MALT lymphoma, a slow-growing cancer of the lymph nodes. Participants first receive a very low dose of radiation (4 Gy total) over two days, then take a daily targeted drug called orelabrutinib for up to 6 months. The goal is to see if this combination can effectively control the disease while reducing long-term side effects like dry mouth or cataracts that can occur with standard radiation. About 60 people will take part, and they will be followed for at least 3 months to check how well the treatment works and how safe it is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Orelabrutinib (a targeted cancer drug) and ultra-low-dose radiation therapy
- What this could lead to
- If successful, this could offer a well-tolerated, effective first-line treatment for early-stage MALT lymphoma with fewer long-term side effects than standard radiation.
- What could go wrong
- This is an early phase 2 trial with only 60 participants, so results may not apply to all patients. The combination may still cause side effects or not work as hoped.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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, all genders eligible; 2. Histopathologically confirmed MALT lymphoma (extranodal marginal zone lymphoma) with at least one measurable lesion outside the spleen, with any diameter \> 1.0 cm; 3. No prior systemic anti-tumor therapy after diagnosis (including chemotherapy, targeted therapy, rituximab, etc.). Note: For patients with primary gastric MALT lymphoma, Helicobacter pylori (HP) must be negative or the patient must have failed standard HP eradication therapy. Patients with MZL who progressed or relapsed after local treatment (including surgery, Helicobacter pylori eradication, and hepatitis C treatment) are eligible for enrollment. 4. ECOG performance status score of 0-1; 5. Presence of treatment indications as judged by the investigator (including symptoms, cytopenias, risk of end-organ damage, bulky disease, or persistent progression); 6. Adequate major organ function, meeting the following criteria: 1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelets ≥ 75 × 10⁹/L, hemoglobin ≥ 75 g/L; If bone marrow involvement is present: ANC ≥ 1.0 × 10⁹/L, platelets ≥ 50 × 10⁹/L, hemoglobin ≥ 50 g/L; 2. Total bilirubin ≤ 1.5 × ULN, AST or ALT ≤ 2 × ULN, serum creatinine ≤ 1.5 × ULN, serum amylase ≤ ULN; 3. International Normalized Ratio (INR) ≤ 1.5 × ULN. 7. Expected survival ≥ 3 months; 8. Voluntarily provide written informed consent before screening. Exclusion Criteria: 1. Current or history of other malignant tumors, except for those who have achieved complete remission after radical treatment; 2. Lymphoma involvement of the central nervous system or transformation to high-grade lymphoma; 3. Patients with other tumors who have not recovered from non-hematologic toxicities of prior anti-tumor therapy to ≤ Grade 1 (except for alopecia); 4. Uncontrolled or significant cardiovascular diseases, including: 1. Congestive heart failure of New York Heart Association (NYHA) Class II or above, unstable angina, myocardial infarction within 6 months before the first dose of the study drug, or arrhythmias requiring treatment at screening, or 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 at screening \> 470 ms for females or \> 450 ms for males; 4. Subjects with symptomatic coronary artery disease requiring medication; 5. Uncontrolled hypertension (despite lifestyle modification and use of a reasonable and tolerable maximum dose of 3 or more antihypertensive drugs \[including diuretics\] for more than 1 month, blood pressure still not reaching target, or blood pressure can only be effectively controlled with 4 or more antihypertensive drugs); 5. Active bleeding within 2 months before screening, or currently receiving anticoagulant drugs, or considered by the investigator to have a clear bleeding tendency; 6. Urine protein ≥ 2+ and 24-hour urine protein quantification ≥ 2 g/24 hours; 7. History of deep vein thrombosis or pulmonary embolism within the past 6 months; 8. History of organ transplantation or allogeneic hematopoietic stem cell transplantation; 9. Major surgery within 6 weeks before screening or minor surgery within 2 weeks before screening. Major surgery is defined as surgery performed under general anesthesia; however, diagnostic endoscopic procedures are not considered major surgery. Insertion of vascular access devices is exempt from this exclusion criterion; 10. HIV/AIDS or other serious infectious diseases; 11. Patients with severe pulmonary function impairment due to pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or other conditions; 12. Previous treatment with BTK inhibitors, BCR pathway inhibitors (e.g., PI3K, Syk), or BCL-2 inhibitors; 13. Subjects with drug abuse or alcohol abuse; 14. Pregnant or lactating women, or subjects of childbearing potential who are unwilling to use contraceptive measures; 15. Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in this trial.
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Conditions
The condition(s) this trial relates to.
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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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No. 1, East Banshan Road , Gongshu District
RECRUITINGHangzhou, Zhejiang, 310000, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, 310000, China
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