Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-01-01 @ 6:28 PM
Study NCT ID:
NCT04517435
Status:
TERMINATED
Last Update Posted:
2025-02-07
First Post:
2020-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma
Sponsor:
Deepa Jagadeesh
Organization:
Study Overview
Official Title:
An Open-Label, Phase I/II Study of ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding unavailable
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 I/II 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 remission),duration 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 remission),duration 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:
True
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?: