Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-02 @ 5:47 AM
Study NCT ID:
NCT04913103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-06-04
First Post:
2021-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of PV in Combination With Bendamustine and Rituximab for Patients With R/R MCL
Sponsor:
Czech Lymphoma Study Group
Organization:
Study Overview
Official Title:
A Phase II, Open-label Study of Polatuzumab-vedotin (PV) in Combination With Bendamustine and Rituximab for Patients With Mantle Cell Lymphoma, Who Relapse After Previous Therapy With Bruton Tyrosine Kinase Inhibitor
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-05
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:
CLSGMCLPOLA
Brief Summary:
A Czech Lymphoma Study Group, phase II, open-label, study of polatuzumab-vedotin in combination with bendamustine and rituximab for patients with mantle cell lymphoma, who relapse after previous therapy with Bruton tyrosine kinase inhibitor
Detailed Description:
Primary objective:
Efficacy: to evaluate the efficacy of the combination of polatuzumab vedotin plus bendamustine and rituximab (BR) with respect to progression-free survival (PFS)
Secondary objectives:
Efficacy: to evaluate the efficacy of polatuzumab vedotin plus BR with respect to secondary efficacy endpoints, namely overall response rate, duration of response, event free survival and overall survival; Safety objective; Exploratory objectives
Efficacy: to evaluate the efficacy of the combination of polatuzumab vedotin plus bendamustine and rituximab (BR) with respect to progression-free survival (PFS)
Secondary objectives:
Efficacy: to evaluate the efficacy of polatuzumab vedotin plus BR with respect to secondary efficacy endpoints, namely overall response rate, duration of response, event free survival and overall survival; Safety objective; Exploratory objectives
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?: