Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284486
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-02-22
Brief Title:
A Multi-Site Break Through Cancer Trial Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Multi-Site Break Through Cancer Trial Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if the combination of venetoclax and revumenib can help to control MRD-positive AML
Detailed Description:
Primary Objectives
Phase I To determine the safety tolerability and recommended phase II dose RP2D of the combination of revumenib and venetoclax for patients with acute myeloid leukemia AML and detectable minimal or measurable residual disease MRD
Phase II To assess the efficacy of the combination of venetoclax and revumenib in clearance of MRD in patients with AML
Secondary Objectives
To assess overall survival OS relapse-free survival RFS event-free survival EFS and duration of response DOR
To determine clinical flow and genetic MRD concordance rate
Exploratory Objectives
To evaluate molecular and cellular markers that may be predictive of antitumor activity andor resistance
To correlate MRD negativity with clinical outcomes survival and relapse risk
To evaluate concordance of standard and novel MRD assays
To explore the safety and activity of venetoclax plus revumenib in the pediatric population
Phase I To determine the safety tolerability and recommended phase II dose RP2D of the combination of revumenib and venetoclax for patients with acute myeloid leukemia AML and detectable minimal or measurable residual disease MRD
Phase II To assess the efficacy of the combination of venetoclax and revumenib in clearance of MRD in patients with AML
Secondary Objectives
To assess overall survival OS relapse-free survival RFS event-free survival EFS and duration of response DOR
To determine clinical flow and genetic MRD concordance rate
Exploratory Objectives
To evaluate molecular and cellular markers that may be predictive of antitumor activity andor resistance
To correlate MRD negativity with clinical outcomes survival and relapse risk
To evaluate concordance of standard and novel MRD assays
To explore the safety and activity of venetoclax plus revumenib in the pediatric population
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01721 | OTHER | NCI-CTRP Clinical Registry | None |