Acute Myeloid Leukemia
Conditions
Keywords
relapsed/refractory acute myeloid leukemia, FLT3+, FLT3 inhibitors, Gilteritinib, infections
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 relapsed/resistant 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 relapsed/refractory FLT3+ acute myeloid leukemia on salvage chemotherapy should also be included.
Interventions
DRUGGilteritinib
observational study to evaluate the incidence of infections during therapy with Gilteritinb
Sponsors
University of Rome Tor Vergata
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| absolute infectious risk in patients treated with Gilteritinib, Infection events of grade 3 or more ( CTCAE v.5.0 ) | 24 months | 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 |
Countries
Italy
Outcome results
None listed