Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT06341556
Status:
RECRUITING
Last Update Posted:
2024-09-04
First Post:
2024-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: