Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641414
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-12
Brief Title:
Lisaftoclax APG-2575 Combined With Azacytidine AZA in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome GLORA-4
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Global Multicenter Double-blind Randomized Registrational Phase 3 Study of Lisaftoclax APG-2575 in Combination With Azacitidine AZA in Patients With Newly Diagnosed Higher Risk Myelodysplastic Syndrome HR-MDS GLORA-4
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:
A global multicenter randomized double-blind placebo-controlled pivotal phase III study To evaluate overall survival OS of Lisaftoclax APG-2575 combined with azacitidine AZA vs placebo combined with azacitidine in newly diagnosed patients with HR-MDS
Detailed Description:
This study intends to enroll patients with HR-MDS to receive the therapy of Lisaftoclax APG-2575 combined with azacitidine AZA or placebo combined with azacitidine
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