Ignite Creation Date:
2024-05-06 @ 4:33 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05024552
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2021-08-23
Brief Title:
Vyxeos Plus Gilteritinib in Relapsed or Refractory FLT3-Mutated AML
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase 1 Study of Vyxeos Plus Gilteritinib in Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This study combines vyxeos and gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia Vyxeos and gilteritinib will be given as induction therapy Those patients entering a complete remission or a complete remission with incomplete blood count recovery will be allowed to proceed to consolidation therapy with vyxeos and gilteritinib Those patients who do not proceed to an allogeneic stem cell transplant for any reason are able to enter the maintenance phase of this trial using daily gilteritinib
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