Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389292
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-24
Brief Title:
A Pivotal Study of APG-2575 Lisaftoclax Combined With Azacytidine in the Treatment of Acute Myeloid Leukemia
Sponsor:
Ascentage Pharma Group Inc
Organization:
Ascentage Pharma Group Inc
Study Overview
Official Title:
An International Multicenter Randomized Double-blind Phase 3 Pivotal Registration Clinical Study of APG-2575 Lisaftoclax in Combination With Azacytidine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-07
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:
An international multicenter randomized double-blind placebo-controlled phase III pivotal registration study to evaluate the efficacy of APG-2575 Lisaftoclax combined with azacitidine AZA versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy
Detailed Description:
The newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy will be randomized to the investigational group Lisaftoclax AZA or the control group placebo AZA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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