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Recruiting NCT06478472

Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local Therapy

Trial Parameters

Condition Marginal Zone Lymphoma
Sponsor The First Affiliated Hospital of Xiamen University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 36
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-06-23
Completion 2027-06-23
Interventions
Orelabrutinib in combination with rituximab

Brief Summary

Orelabrutinib combined with rituximab (OR) therapy were used to assess the efficacy and safety for newly diagnosed Marginal zone cell lymphoma

Eligibility Criteria

Inclusion Criteria: 1. Age: ≥18 years old, gender is not limited; 2. Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, NMZL; 3. Indications for treatment: impact on organ function, development of symptoms associated with lymphoma, large masses, hematopenia secondary to lymphoma; 4. MZL that has progressed, relapsed, or is unsuitable for local therapy after prior local therapy (local therapy includes surgery, radiotherapy, anti-Helicobacter pylori therapy, anti-hepatitis C therapy); 5. ECOG 0-2; 6. Must have at least one measurable or evaluable lesion using the Lugano 2014 Lymphoma Efficacy Evaluation Criteria: i.e., PET/CT with an evaluable lesion; an intranodal lesion with a long diameter greater than 1.5 cm and a short diameter greater than 1.0 cm or an extranodal lesion with a long diameter of \> 1.0 cm, as assessed by CT or MR 7. Participants with splenic MZL who do not meet the above criteria for radiologically measurable disease are eligible

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