New drug duo aims to control rare lymphoma without chemotherapy
NCT ID NCT06647732
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times
Summary
This study tests whether combining zanubrutinib (a targeted pill) with rituximab (an antibody infusion) can shrink or control MALT lymphoma, a slow-growing cancer of the lymph nodes and organs. About 42 adults with newly diagnosed advanced disease or lymphoma that returned after local treatment will receive the combination. The goal is to see how many patients achieve complete remission and how long the benefit lasts.
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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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42 people
The number who actually took part.
- Started
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Oct 2024
- Expected to finish
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Sep 2028
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key inclusion Criteria: 1. Mucosa-associated lymphoid tissue (MALT) extranodal marginal zone lymphoma confirmed by histopathology. 2. Newly diagnosed with Ann Arbor stage III-IV or relapsed MALT after local treatment . 3. No prior systemic anti-lymphoma therapy (except for H. pylori eradication therapy in H. pylori-positive gastric MALT patients). 4. No histopathological transformation to high-grade lymphoma. 5. At least one measurable lesion according to the Lugano 2014 criteria. 7\. Age ≥ 18 years, with no gender restrictions. 7. An ECOG performance status score of 0-2. 8. An expected survival time of more than 12 months. 9. Adequate bone marrow, cardiac, pulmonary, liver, and kidney function. 10. Willing to participate in the clinical study; fully informed and aware of the study, having signed the informed consent form; willing and able to comply with all study procedures. Key exclusion Criteria: 1. Patients with a history of stroke, intracranial hemorrhage, or warfarin use within the past 6 months. 2. Patients with central nervous system involvement. 3. Patients who have undergone allogeneic hematopoietic stem cell transplantation in the past. 4. Patients who have previously used BTK inhibitors or received CD20 monoclonal antibody therapy. 5, Patients with active infections, except for tumor-related B-symptom fever. 6. Patients with a concurrent history of other malignancies, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin. 7\. Patients receiving potent cytochrome P450 inhibitors. 8. Patients with severe cardiovascular diseases, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or a history of myocardial infarction within the past 12 months. 9\. Patients, as judged by the investigator, who have significant organ dysfunction or uncontrollable comorbidities that pose a safety risk, or who have absorption and metabolism issues with Zanubrutinib. 10\. Pregnant or breastfeeding women and women of childbearing age unwilling to use contraception. 11\. Patients who have received anti-tumor therapy within 4 weeks prior to enrollment. 12\. Patients with active chronic hepatitis B or active hepatitis C. 13. Patients who have received systemic corticosteroid treatment or other immunosuppressive therapy within 14 days prior to the start of study treatment.
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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.
Contacts and locations
Locations
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Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, 51000, China