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Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma

RecruitingPhase 4Ages 18 Years - anyAllBeijing Tongren Hospital
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In plain words

What the trial is, and whether it could suit you

This study focuses on treatment-naïve marginal zone lymphoma (MZL) patients and aims to investigate the efficacy and safety of orelabrutinib combined with or without CD20 monoclonal antibody. This is a single-arm study without a control group. All subjects will receive orelabrutinib treatment but will be stratified based on disease stage and clinical characteristics into the following two groups: 1. Stage I MZL Patient Group (Monotherapy Group) Treatment regimen: Orelabrutinib monotherapy. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). Target population: Patients with Ann Arbor Stage I gastric MALT MZL, including H. pylori-negative patients or those with unsatisfactory response after anti-H. pylori therapy, as well as other Stage I MZL patients unsuitable for local radiot

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years; * Pathologically confirmed marginal zone lymphoma; * Presence of evaluable lesions; * Meets indications for treatment: Fulfills the GELF criteria OR has disease-related clinical symptoms/organ function impairment; * Patients who are unsuitable for local radiotherapy, refuse local radiotherapy, or have disease progression after local therapy. Cases considered unsuitable for local radiotherapy include the following: Gastric MALT MZL, Ann Arbor stage I, that is H. pylori-negative, or H. pylori-positive gastric MALT MZL (Ann Arbor stage I) with poor response to H. pylori eradication therapy; Non-gastric MALT and nodal MZL in Ann Arbor non-contiguous stage II or stages III-IV; SMZL; Gastric MALT classified as Lugano II2, IIE, or IV stage; Patient intolerance to radiotherapy; Other MZL patients deemed unsuitable for local radiotherapy by the investigator. * ECOG score of 0-3; * Expected survival time ≥ 3 months; * Ability to provide signed informed consent. Exclusion Criteria: * Currently diagnosed with another malignant tumor; * Central nervous system involvement by lymphoma or transformation to a higher grade; * Allergy to any of the investigational drugs; * Active infection or uncontrolled HBV infection, HIV/AIDS, or other serious infectious diseases; * Pregnancy, lactating women, or subjects of childbearing potential unwilling to use contraception; * Other situations deemed by the investigator as unsuitable for participation in this trial.
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What it tests

  • Orelabrutinib
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Where

3 sites
Beijing Tongren Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
The First Affiliated Hospital of China Medical University
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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