GilteRInf 2022 Study (Gilteritinib Related Infections)

Study Overview
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Brief Summary
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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.

Detailed Description
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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 relapsed/refractory FLT3+ acute myeloid leukemia on salvage chemotherapy should also be included.

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

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Gilteritinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who receive or have received Gilteritinib<br>the retrospective part, clinical data will be collected on all patients with LMA FLT3+ (ITD or TKD mutation) 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. | Drug: Gilteritinib<br>* observational study to evaluate the incidence of infections during therapy with Gilteritinb<br>|
| Case control<br>for each case of a patient receiving salvage monotherapy with Gilteritinib, a control patient with R/R AML FLT3+ on salvage chemotherapy should also be included. | Drug: Gilteritinib<br>* observational study to evaluate the incidence of infections during therapy with Gilteritinb<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absolute infectious risk in patients treated with Gilteritinib, Infection events of grade 3 or more ( CTCAE v.5.0 ) | To assess real-life in patients with relapsed/refractory FLT3+ LMA treated with Gilteritinib the absolute infectious risk and compare it with relapsed/refractory patients receiving chemotherapy. The | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapsed/refractory acute myeloid leukemia, FLT3 inhibitors, Gilteritinib, infections, FLT3+