Could a lower dose of radiation plus a targeted pill treat this lymphoma just as well?
NCT ID NCT07705308
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This study is for people with a slow-growing type of lymphoma called MALT lymphoma that has not spread. It compares a very low dose of radiation (4 Gy) combined with the targeted drug orelabrutinib against the standard higher dose of radiation (24 Gy). The goal is to see if the gentler combination can shrink tumors just as effectively while causing fewer side effects. About 140 adults with confirmed MALT lymphoma will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of low-dose radiotherapy (4 Gy) and a targeted drug called orelabrutinib
- What this could lead to
- If successful, this approach could offer a gentler, effective treatment option for localized MALT lymphoma, potentially reducing long-term side effects from standard radiation.
- What could go wrong
- This is a Phase 2 trial, so results are preliminary. The combination may not improve outcomes over standard therapy, and there could be unexpected side effects from the drug or radiation.
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 140 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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May 2031
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: * Patients must meet all of the following criteria to be eligible for enrollment in this study: * The patient voluntarily agrees to participate in this study and provides written informed consent; * Age ≥ 18 years; * Histopathologically confirmed diagnosis of extranodal marginal zone B-cell lymphoma of the mucosa-associated lymphoid tissue (MALT) type; * Involved sites include but are not limited to: orbit, parotid gland, thyroid, Helicobacter pylori (H. pylori)-negative gastric MALT (in this study, H. pylori-negative gastric MALT is defined as negative results on both gastric mucosal tissue biopsy and serum H. pylori antibody test within the past 6 months; for patients with unknown prior H. pylori status who have received anti-H. pylori therapy, a positive serum H. pylori antibody test is permissible, provided that a subsequent gastroscopy or urea breath test confirms negativity); * Lugano stage I-II disease; * Able to swallow tablets normally; * Eastern Cooperative Oncology Group performance status (ECOG-PS) score of 0-2; * No prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy for MALT lymphoma; * Life expectancy ≥ 12 months; * Adequate major organ function, meeting the following criteria: 1. Hematological parameters: absolute neutrophil count ≥ 1.0 × 10⁹/L; platelet count ≥ 50 × 10⁹/L; hemoglobin ≥ 80 g/L; 2. Biochemical parameters: total bilirubin \< 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance \> 50 mL/min; * Female patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment and must agree to use highly effective methods of contraception during the study period and for 120 days after the last dose. Male patients with female partners of childbearing potential must be surgically sterile or agree to use highly effective methods of contraception during the study period and for 120 days after the last dose. Exclusion Criteria: * Patients who meet any of the following criteria will be excluded from enrollment in this study: * Major surgery (excluding diagnostic surgery) within 4 weeks prior to enrollment; * Previous or concurrent diagnosis of another malignancy, with the exception of adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast; * Active chronic hepatitis B infection, defined as detectable HBV DNA; * Active HIV or syphilis infection; * Presence of severe concomitant medical conditions or circumstances that may affect the patient's eligibility or safety during the study period; * Pregnant or breastfeeding women; * Presence of active psychiatric disorders or other psychological conditions that may impair the patient's ability to provide informed consent or understand the study procedures; * Patients considered by the investigator to have poor compliance; Pathologically or radiologically confirmed distant metastasis; Other factors that, in the investigator's judgment, may affect the study results or necessitate premature termination of the study, including but not limited to alcohol abuse, drug abuse, other severe diseases (including psychiatric disorders) requiring concomitant treatment, significant laboratory abnormalities, or family/social circumstances that may compromise patient safety.
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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
3 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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Fudan University Affiliated Minhang Hospital
Shanghai, Shanghai Municipality, China
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Huadong Hospital
Shanghai, Shanghai Municipality, China
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Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
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