NCT06341556

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

In this study, 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). This study aims to evaluate whether maintenance therapy with Zanubrutinib monotherapy could improve the 2-year progression free survival (PFS) of those patients, and explore the efficiency and safety.

Conditions

• Mantle Cell Lymphoma
• Maintenance Therapy

Interventions

Type	Name	Description
DRUG	Zanubrutinib	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).

Timeline

• Start date: 2024-05-24
• Primary completion: 2026-03-01
• Completion: 2028-06-01
• First posted: 2024-04-02
• Last updated: 2024-09-04

Locations

2 sites across 1 country: China