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Recruiting Phase 2 NCT06504940

Optimize Study - Orelabrutinib Combined With BR/G in Untreated Marginal Zone Lymphoma (MZL)

Trial Parameters

Condition Marginal Zone Lymphoma
Sponsor First Affiliated Hospital of Zhejiang University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 69
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-06-28
Completion 2027-07-08
Interventions
Orelabrutinib combined with bendamustine and rituximabOrelabrutinib combined with obinutuzumab

Brief Summary

This is a multi-center, prospective cohort study. The main purpose of Cohort A is to evaluate the efficacy and safety of Orelabrutinib combined with BR (bendamustine and rituximab) for previously untreated young patients with MZL; the purpose of Cohort B is to assess the efficacy and safety of Orelabrutinib combined with G (Obinutuzumab) followed by Orelabrutinib maintenance therapy for previously untreated elderly patients with MZL.

Eligibility Criteria

Inclusion Criteria: 1. For Cohort A: Age 18-70 years, physical condition assessed by a physician as suitable for chemotherapy; for Cohort B: Age 70 or older or under 70 years of age assessed by a physician as unsuitable for chemotherapy. 2. Gender is not limited. 3. Confirmed by histopathology, marginal zone lymphoma including MALT, SMZL, NMZL. 4. Progression, recurrence after local treatment, or unsuitable for local treatment (local treatments include surgery, radiotherapy, Helicobacter pylori treatment, hepatitis C treatment). 5. ECOG performance score 0-3 points (if the score is 3 points, the physician needs to assess that the deterioration of physical condition is mainly due to tumor burden). 6. Indications for treatment (with B symptoms, blood cell decline, bleeding, large mass, rapid progression of tumors, etc.). 7. Major organ functions meet the following criteria: a) Complete blood count: Absolute neutrophil count ≥1.5×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥75g/L; if accom

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