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Clinical trial

Observational Study on the Incidence of Infections in Patients With Relapsed/Refractory FMS-like Tyrosine Kinase 3 Acute Myeloid Leukemia Treated With Gilteritinib

ID
Name
GilteRInf 2022
Description
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 relapsed/resistant acute myeloid leukemia who receive Gilteritinib therapy, given that recent approval of this drug.
Trial arms
Trial start
2022-05-31
Estimated PCD
2024-05-31
Trial end
2024-12-31
Status
Active (not recruiting)
Treatment
Gilteritinib
observational study to evaluate the incidence of infections during therapy with Gilteritinb
Arms:
Case control, Patients who receive or have received Gilteritinib
Size
78
Primary endpoint
absolute infectious risk in patients treated with Gilteritinib, Infection events of grade 3 or more ( CTCAE v.5.0 )
24 months
Eligibility criteria
Inclusion Criteria: Population * All patients with FLT3+ relapsed/refractory AML to any line of therapy treated with Gilteritinib * Patients ≥18 years of age * Signature of appropriate informed consent Exclusion criteria: - Patients \< 18 years old
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 78, 'type': 'ESTIMATED'}}
Updated at
2023-03-30

1 organization

1 product

1 indication

Organization
University of Rome Tor Vergata
Product
Gilteritinib
Indication
Acute Myeloid Leukemia