Ignite Creation Date:
2024-05-06 @ 2:32 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04342962
Status:
RECRUITING
Last Update Posted:
2022-01-10
First Post:
2020-04-09
Brief Title:
Tagraxofusp in Patients With CD123 or With BPDCN-IPh-like Acute Myeloid Leukemia
Sponsor:
Gruppo Italiano Malattie EMatologiche dellAdulto
Organization:
Gruppo Italiano Malattie EMatologiche dellAdulto
Study Overview
Official Title:
Tagraxofusp in Patients With CD123 or With Blastic Plasmacytoid Dendritic Cell Neoplasm Immunophenotype-like Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2021-12
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:
Non-randomized open-label multicenter phase II Study for the treatment of
25 RR BPDCN-IF CD123CD4CD56 positive AML patients and
25 patients presenting RR AML CD123 but negative for either or both CD4 and CD56
Patients will be treated with 12 mcgkgday of tagraxofusp for 5 days for at least 4 cicles
25 RR BPDCN-IF CD123CD4CD56 positive AML patients and
25 patients presenting RR AML CD123 but negative for either or both CD4 and CD56
Patients will be treated with 12 mcgkgday of tagraxofusp for 5 days for at least 4 cicles
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?:
None
Is an FDA AA801 Violation?:
None