Phase 2 Study of Orelabrutinib with Zebetuzumab and Lenalidomide or Bendamustine with Rituximab for Newly Diagnosed Marginal Zone Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two treatment combinations for adults newly diagnosed with marginal zone lymphoma MZL. This phase 2, open-label, multicenter study compares orelabrutinib combined with zebetuzumab and lenalidomide against bendamustine combined with rituximab. The goal is to understand how well these treatments work and their safety in treating this type of lymphoma. Participants will receive one of two treatment plans. The first group undergoes an induction phase of six 28-day cycles with orelabrutinib, zebetuzumab, and lenalidomide, followed by a maintenance phase of 24 cycles with orelabrutinib if they respond well. The second group receives six 28-day cycles of bendamustine and rituximab. Treatment dosing and schedule are carefully monitored throughout the study. During the study, participants will have regular assessments including response evaluations at multiple cycle days, quality of life questionnaires, and monitoring of side effects. Researchers will track progression-free survival up to 66 months, overall survival, and other key outcomes. Safety will be observed from screening through three years after maintenance therapy ends. Participants may be involved for several years in total to allow detailed evaluation of treatment effects and safety.

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