Viewing Study NCT06456463



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