RecruitingPhase 2NCT07208981

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


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

169 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of three drugs — Orelabrutinib, Zebetuzumab, and Lenalidomide — for people newly diagnosed with marginal zone lymphoma (MZL), a slow-growing type of blood cancer that affects the lymph nodes, spleen, or stomach. **You may be eligible if...** - You are 18–75 years old - You have been newly diagnosed with marginal zone lymphoma confirmed by tissue biopsy (MALT, splenic MZL, or nodal MZL) - Your cancer is CD20-positive (a protein found on the cancer cells) - You have at least one measurable area of disease - Your disease meets standard treatment criteria (symptoms, organ damage, rapid progression, or patient preference) **You may NOT be eligible if...** - You have previously received treatment for this lymphoma - You have certain active infections, poor organ function, or other serious health conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrelabrutinib

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.

DRUGZebetuzumab

Induction treatment phase (a total of 6 cycles, each cycle lasting 28 days), Zebetuzumab (375 mg/m2, d1/C1-C6).

DRUGLenalidomide

Induction treatment phase (a total of 6 cycles, each cycle lasting 28 days), Lenalidomide (20 mg, d1-d21).

DRUGBendamustine + 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

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NCT07208981


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