Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341556
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-20
Brief Title:
A Multicenter Prospective Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma
Sponsor:
Fudan University
Organization:
Fudan University
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:
None
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?:
None