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RECRUITING
NCT07208981
PHASE2

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

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

169

Start Date

2025-08-14

Completion Date

2031-06-01

Last Updated

2025-10-06

Healthy Volunteers

No

Interventions

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).

Locations (1)

The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital

Nanjing, Jiangsu, China