Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652438
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Revumenib in Combination With Azacitidine Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Study to Assess Revumenib in Combination With Azacitidine Venetoclax in Adult Patients With Newly Diagnosed NPM1-mutated or KMT2A-rearranged AML Ineligible for Intensive Chemotherapy
Status:
NOT_YET_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:
Treatment of patients with newly diagnosed AML who are not eligible for intensive chemotherapy has remained an area of high unmet medical need The combination therapy with two medicines azacitidine and venetoclax is the usual plan of action This has brought significant progress in the treatment but it nevertheless is not curative and the disease does relapse over time
Revumenib blocks a specific molecule called menin in the cell nucleus Some types of AML are reliant on menin working properly These are leukemia cells with a change in the DNA ie a mutation in the NPM1 or KMT2A gene Revumenib can prevent the production of these types of leukemia cells by disrupting the production of this menin
The current study investigates whether adding revumenib to the combination therapy improves the prognosis for AML patients with a mutation in the NPM1 or KMT2A gene
This is a randomized double-blind placebo-controlled clinical study where subjects will be treated until disease progression or development of side effects or death From the moment of inclusion of the last patient there will be a 4-year observational follow-up study in order to register survival duration and follow-up visits
Approximately 415 previously untreated patients with a mutation in the NPM1 or KMT2A gene and with newly diagnosed AML who are not eligible for intensive chemotherapy Patients must be 18 years of age
Revumenib blocks a specific molecule called menin in the cell nucleus Some types of AML are reliant on menin working properly These are leukemia cells with a change in the DNA ie a mutation in the NPM1 or KMT2A gene Revumenib can prevent the production of these types of leukemia cells by disrupting the production of this menin
The current study investigates whether adding revumenib to the combination therapy improves the prognosis for AML patients with a mutation in the NPM1 or KMT2A gene
This is a randomized double-blind placebo-controlled clinical study where subjects will be treated until disease progression or development of side effects or death From the moment of inclusion of the last patient there will be a 4-year observational follow-up study in order to register survival duration and follow-up visits
Approximately 415 previously untreated patients with a mutation in the NPM1 or KMT2A gene and with newly diagnosed AML who are not eligible for intensive chemotherapy Patients must be 18 years of age
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None