Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372717
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-03-11
Brief Title:
A Study to Investigate APL-4098 Alone andor in Combination With Azacitidine in RR AML and High-Risk MDS
Sponsor:
Apollo Therapeutics Ltd
Organization:
Apollo Therapeutics Ltd
Study Overview
Official Title:
A Phase 12 Study to Assess the Safety and Antitumor Activity of APL-4098 Alone andor in Combination With Azacitidine in Adults With Relapsed or Refractory RR Acute Myeloid Leukemia AML Myelodysplastic SyndromeAML MDSAML or Myelodysplastic Syndrome With Excess Blasts MDS-EB
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This is an open-label Phase 12 study to determine the safety tolerability and efficacy of APL-4098 alone andor in combination with azacitidine for the treatment of relapsed or refractory RR acute myeloid leukemia AML myelodysplastic syndrome MDSAML and MDS-excess blasts EB Participants with the MDS-EB subtype will be eligible for the Phase 1 part of the study only
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None