Trials / Unknown
UnknownNCT05791890
GilteRInf 2022 Study (Gilteritinib Related Infections)
Observational Study on the Incidence of Infections in Patients With Relapsed/Refractory FMS-like Tyrosine Kinase 3 Acute Myeloid Leukemia Treated With Gilteritinib
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 78 (estimated)
- Sponsor
- University of Rome Tor Vergata · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gilteritinib | observational study to evaluate the incidence of infections during therapy with Gilteritinb |
Timeline
- Start date
- 2022-05-31
- Primary completion
- 2024-05-31
- Completion
- 2024-12-31
- First posted
- 2023-03-30
- Last updated
- 2023-03-30
Locations
1 site across 1 country: Italy
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05791890. Inclusion in this directory is not an endorsement.