NCT07208981

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

A Prospective Multicenter Study of Orelabrutinib Combined With Zebetuzumab and Lenalidomide or Bendamustine Combined With Rituximab for the Treatment of Newly Diagnosed MZL

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 169 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Marginal Zone Lymphoma(MZL)

Interventions

Type	Name	Description
DRUG	Orelabrutinib	Induction treatment phase (a total of 6 cycles, each cycle lasting 28 days), Orelabrutinib (150 mg, d1-d28). Maintenance phase (a total of 24 cycles, each cycle lasting 28 days), Orelabrutinib (150 mg, d1-d28). Patients who achieve complete remission (CR) or partial remission (PR) after 6 cycles will decide whether to undergo maintenance therapy based on the investigator's choice.
DRUG	Zebetuzumab	Induction treatment phase (a total of 6 cycles, each cycle lasting 28 days), Zebetuzumab (375 mg/m2, d1/C1-C6).
DRUG	Lenalidomide	Induction treatment phase (a total of 6 cycles, each cycle lasting 28 days), Lenalidomide (20 mg, d1-d21).
DRUG	Bendamustine + Rituximab	Treatment period (a total of 6 cycles, each cycle lasting 28 days), Bendamustine (90 mg/m2, d1-2), Rituximab (375 mg/m2, d1/C1-6).

Timeline

• Start date: 2025-08-14
• Primary completion: 2028-06-01
• Completion: 2031-06-01
• First posted: 2025-10-06
• Last updated: 2025-10-06

Locations

1 site across 1 country: China