Ignite Creation Date:
2024-05-06 @ 6:08 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05551936
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2022-09-19
Brief Title:
A Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma
Sponsor:
Vaishalee Kenkre
Organization:
Big Ten Cancer Research Consortium
Study Overview
Official Title:
A Single Arm Phase III Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma Big Ten Cancer Research Consortium BTCRC-LYM20-463
Status:
RECRUITING
Status Verified Date:
2024-10
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 is planned as a single arm clinical trial of tazemetostat in combination with bendamustine and rituximab with both a phase I and phase II component All patients will receive tazemetostat twice daily on days 1-28 in combination with bendamustine 90 mgm2 IV on days 1 and 2 and rituximab 375 mgm2 IV on day 1 of a 28-day cycle for up to three cycles Following this patients will receive tazemetostat twice daily on days 1-28 and rituximab 375 mgm2 IV on day 1 of a 28-day cycle for up to three cycles
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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