Ignite Creation Date:
2024-07-17 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496308
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
A Multicenter Open-label Randomized Controlled Study of Orelabrutinib in Combination With Bendamustine and Rituximab Versus Bendamustine and Rituximab in the Treatment of Transplant-Ineligible Intermediate- to High-Risk Mantle Cell Lymphoma MCL
Status:
RECRUITING
Status Verified Date:
2024-07
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 multicenter open-label randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab OBR versus Bendamustine and Rituximab BR in patients with intermediate- to high-risk mantle cell lymphoma MCL who are ineligible for transplantation The primary objective is to assess the complete response CR rate during the induction phase with secondary objectives including progression-free survival PFS overall survival OS objective response rate ORR and safety Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy
Detailed Description:
None
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