Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05791890
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-30
First Post:
2023-03-05
Brief Title:
GilteRInf 2022 Study Gilteritinib Related Infections
Sponsor:
University of Rome Tor Vergata
Organization:
University of Rome Tor Vergata
Study Overview
Official Title:
Observational Study on the Incidence of Infections in Patients With RelapsedRefractory FMS-like Tyrosine Kinase 3 Acute Myeloid Leukemia Treated With Gilteritinib
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
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:
GilteRInf
Brief Summary:
The study is observational retrospective-prospective multicenter real-life study involving 26 centers belonging to the SEIFEM group The goal of this study is to obtain a real-life experience in the management and outcome of infectious issues of patients with relapsedresistant acute myeloid leukemia who receive Gilteritinib therapy given that recent approval of this drug
Detailed Description:
The study is observational retrospective-prospective multicenter real-life study Regarding the retrospective part clinical data will be collected on all patients with acute myeloid leukemia FLT3 treated with Gilteritinib from when the drug was approved and marketed in Italy April 2 2020 until April 30 2022 Enrollment in the prospective cohort will have an estimated duration of 24 months from the time of study approval Patients enrolled in the last month will be followed for six months from the date of enrollment to check for the occurrence of any infections For each case of a patient receiving salvage monotherapy with Gilteritinib a control patient with relapsedrefractory FLT3 acute myeloid leukemia on salvage chemotherapy should also be included
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