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Recruiting Phase 2 NCT07208981

Orelabrutinib Combined With Zebetuzumab and Lenalidomide for the Treatment of Newly Diagnosed MZL

Trial Parameters

Condition Marginal Zone Lymphoma(MZL)
Sponsor The First Affiliated Hospital with Nanjing Medical University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 169
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-08-14
Completion 2028-06-01
Interventions
OrelabrutinibZebetuzumabLenalidomide

Brief Summary

This is an open-label, multicenter, phase 2, non-randomized study aiming to evaluate the efficacy and safety of orelabrutinib combined with zebetuzumab and lenalidomide or bendamustine combined with rituximab in the treatment of newly diagnosed marginal zone lymphoma (MZL).

Eligibility Criteria

Inclusion Criteria: * 1\. Age 18-75 years, gender not restricted; * 2\. Histopathologically confirmed CD20-positive marginal zone lymphoma includes MALT, SMZL, and NMZL; at least one measurable lesion; * 3\. Indication for treatment * 3.1. Initial diagnosis II 2 or IIE or IV stage gastric MALT treatment indications. Including: ① Meeting the inclusion criteria for clinical trials; ② Presence of lymphoma-related clinical symptoms; ③ Gastrointestinal bleeding (bleeding condition controlled or assessed by the investigator for suitability of inclusion); ④ End-organ damage; ⑤ Large mass; ⑥ Persistent or rapid disease progression; ⑦ Patient's willingness; * 3.2. Recommendations for treatment indications of newly diagnosed stage III-IV non-gastric MALT and NMZL. The GELF criteria, similar to those used for follicular lymphoma, include: ① The presence of ≥3 distinct regions of involved lymph nodes, with each involved lymph node having a diameter of ≥3 cm; ② The presence of any lymph node or ext

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