GilteRInf 2022 Study (Gilteritinib Related Infections)
- Registration Number
- NCT05791890
- Lead Sponsor
- University of Rome Tor Vergata
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 78
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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients who receive or have received Gilteritinib Gilteritinib 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. Case control Gilteritinib 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Maria Ilaria Del Principe
🇮🇹Roma, RM, Italy