GilteRInf 2022 Study (Gilteritinib Related Infections)

University of Rome Tor Vergata

Status: Active, not recruiting

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Gilteritinib

Study type: Observational

Funder types: Other

Identifiers

NCT05791890

GilteRInf 2022

Details and patient eligibility

About

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.

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

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

78 participants in 2 patient groups

Patients who receive or have received Gilteritinib

Description:

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.

Treatment:

Drug: Gilteritinib

Case control

Description:

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.

Treatment:

Drug: Gilteritinib