RecruitingPhase 2NCT06341556

A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma

Zanubrutinib for Maintenance Therapy in Patients With Mantle Cell Lymphoma Who Have Remission After First-line Immunochemotherapy- a Multicenter, Prospective, Phase II Study


Sponsor

Fudan University

Enrollment

52 participants

Start Date

May 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate whether maintenance therapy with Zanubrutinib monotherapy could improve the 2-year progression free survival (PFS) of patients with mantle cell lymphoma who had remission after first-line immunochemotherapy


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests zanubrutinib (a targeted oral drug) as maintenance therapy — ongoing treatment to keep cancer from coming back — in patients with mantle cell lymphoma (a type of blood cancer) who have already responded to their first round of treatment. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of mantle cell lymphoma - Your cancer responded well (complete or partial response) to your first treatment, which included at least 4 cycles of chemo-immunotherapy - Previous stem cell transplant is allowed - Your blood counts, liver, kidney, and heart function are within acceptable ranges **You may NOT be eligible if...** - You have a known allergy to zanubrutinib or similar monoclonal antibodies - Your cancer has relapsed or progressed - You have active, uncontrolled infections - You are pregnant or breastfeeding - You have significant heart rhythm problems or uncontrolled bleeding disorders 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

DRUGZanubrutinib

Patients diagnosed with mantle cell lymphoma who have achieved remission (CR or PR) by first-line immunochemotherapy, will be treated with Zanubrutinib monotherapy for 2 years (or until PD, intolerable toxicity, death, withdrawal, or study termination).


Locations(2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06341556


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