Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456463
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-31
Brief Title:
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123 Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
Sponsor:
Stemline Therapeutics Inc
Organization:
Stemline Therapeutics Inc
Study Overview
Official Title:
A Phase II Multicenter Open-label Trial of Tagraxofusp Tag in Combination With Venetoclax and Azacitidine VenAza in Adults With Previously Untreated CD123 Acute Myeloid Leukemia AML Who Are Ineligible for Intensive Chemotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 study will be divided into 2 parts Part 1 and Part 2 Part 1 will evaluate 2 doses of tagraxofusp used in combination with venetoclax and azacitidine to determine the dose for Part 2 This determined dose in combination with venetoclax and azacitidine will then be further evaluated in Part 2 Both parts will be conducted in participants with previously untreated CD123 AML who are ineligible for intensive chemotherapy
Detailed Description:
None
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 |
|---|---|---|---|
| U1111-1290-9087 | OTHER | UTN | None |
| 2024-514660-48-00 | CTIS | None | None |