Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04517435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-20
First Post:
2020-08-14
Brief Title:
ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma
Sponsor:
Deepa Jagadeesh
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
An Open-Label Phase III Study of ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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 being done to evaluate if ME-401 can improve the treatment of patients with diffuse large b-celllymphoma DLBCL Many patients with DLBCL that are treated with the standard of care R-CHOP are cured However a little less than half of patients will have their cancer come back despite being treated Once DLBCL comes back it is much harder to treat and treatment is much more aggressive This study will combine ME-401 with R-CHOP There are 2 parts to this study part1 referred to as phase I and part 2 referred to as phase 2 The goal of the phase I study is to find the safest dose to give patients in combination with R-CHOP The goal of the phase 2 study is to use the safest dose found in phase 1 in combination with R-CHOP to see if it decreases the rate of cancer coming back after it is treated
Detailed Description:
This study is a multi-institution open-label phase III study designed to evaluate the safety and efficacy of R-CHOP ME-401 for participants with newly diagnosed DLBCL
Objectives for the phase I portion of this study are as follows
Primary objectives
To determine the recommended phase 2 dose RP2D of ME-401in combination with R-CHOP for participants with newly diagnosed DLBCL
To describe tolerability of ME-401 in combination with R-CHOP for participants with newly diagnosed DLBCL
Objectives for the phase II portion of this study are as follows
To estimate the clinical activity of ME-401 in combination with R-CHOP in participants with newly diagnosed DLBCL as measured by 1 year PFS rate
To estimate the response rates complete and partial remissionduration of response DOR time to progression TTP and overall survival OS with ME-401 plus R-CHOP
To characterize treatment-related AEs in participants treated with ME-401 plus R-CHOP
Objectives for the phase I portion of this study are as follows
Primary objectives
To determine the recommended phase 2 dose RP2D of ME-401in combination with R-CHOP for participants with newly diagnosed DLBCL
To describe tolerability of ME-401 in combination with R-CHOP for participants with newly diagnosed DLBCL
Objectives for the phase II portion of this study are as follows
To estimate the clinical activity of ME-401 in combination with R-CHOP in participants with newly diagnosed DLBCL as measured by 1 year PFS rate
To estimate the response rates complete and partial remissionduration of response DOR time to progression TTP and overall survival OS with ME-401 plus R-CHOP
To characterize treatment-related AEs in participants treated with ME-401 plus R-CHOP
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