RecruitingPhase 2NCT06504940

Optimize Study - Orelabrutinib Combined With BR/G in Untreated Marginal Zone Lymphoma (MZL)

Orelabrutinib Combined With BR/G Followed by Orelabrutinib Maintenance Therapy for Newly Diagnosed Marginal Zone Lymphoma (MZL): A Prospective ,Multicenter, Clinical Study


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

69 participants

Start Date

Jun 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center, prospective cohort study. The main purpose of Cohort A is to evaluate the efficacy and safety of Orelabrutinib combined with BR (bendamustine and rituximab) for previously untreated young patients with MZL; the purpose of Cohort B is to assess the efficacy and safety of Orelabrutinib combined with G (Obinutuzumab) followed by Orelabrutinib maintenance therapy for previously untreated elderly patients with MZL.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests orelabrutinib (a BTK inhibitor — a targeted therapy that blocks a protein that helps cancer cells grow) combined with standard chemotherapy regimens (BR or G) for patients with previously untreated marginal zone lymphoma, a slow-growing type of blood cancer. **You may be eligible if...** - You have newly confirmed marginal zone lymphoma (MALT, splenic, or nodal subtype) - Your cancer has progressed after local treatment or is not suitable for local treatment - You have signs that treatment is needed (symptoms, blood count problems, rapid tumor growth) - You are in acceptable physical condition (ECOG 0–3) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have already received systemic treatment for marginal zone lymphoma - You have serious uncontrolled medical conditions - You are pregnant or breastfeeding - Your blood counts are below the required levels 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 combined with bendamustine and rituximab

they will receive three cycles of Orelabrutinib combined with bendamustine and rituximab (BR: bendamustine 70mg/m\^2 on days 1-2; rituximab 375mg/m\^2 on day 0). Patients achieving PR or better will enter the Orelabrutinib monotherapy maintenance phase (up to 21 cycles, each cycle 28 days).

DRUGOrelabrutinib combined with obinutuzumab

they will receive six cycles of Orelabrutinib combined with obinutuzumab (G 1000mg iv on days 1, 8, 15 of cycle 1, and day 1 of cycles 2-6; Orelabrutinib 150mg once daily). Patients achieving PR or better will enter the Orelabrutinib monotherapy maintenance phase (up to 18 cycles, each cycle 28 days ).


Locations(1)

The First Affiliated Hospital ,Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06504940


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