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Trial Title:
GilteRInf 2022 Study (Gilteritinib Related Infections)
NCT ID:
NCT05791890
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Infections
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Gilteritinib
Conditions: Keywords:
relapsed/refractory acute myeloid leukemia
FLT3+
FLT3 inhibitors
Gilteritinib
infections
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Drug
Intervention name:
Gilteritinib
Description:
observational study to evaluate the incidence of infections during therapy with
Gilteritinb
Arm group label:
Case control
Arm group label:
Patients who receive or have received Gilteritinib
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.
Criteria for eligibility:
Study pop:
Relapsed/refractory AML patients
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Maria Ilaria Del Principe
Address:
City:
Roma
Zip:
00133
Country:
Italy
Start date:
May 31, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
University of Rome Tor Vergata
Agency class:
Other
Source:
University of Rome Tor Vergata
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05791890
