GilteRInf 2022 Study (Gilteritinib Related Infections)

Sponsor

University of Rome Tor Vergata (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05791890

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: Gilteritinib

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

78 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

Observational Study on the Incidence of Infections in Patients With Relapsed/Refractory FMS-like Tyrosine Kinase 3 Acute Myeloid Leukemia Treated With Gilteritinib

Actual Study Start Date :

May 31, 2022

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patients who receive or have received 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.	Drug: Gilteritinib observational study to evaluate the incidence of infections during therapy with Gilteritinb
Case control 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.	Drug: Gilteritinib observational study to evaluate the incidence of infections during therapy with Gilteritinb

Arm

Intervention/Treatment

Patients who receive or have received 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.

Drug: Gilteritinib

observational study to evaluate the incidence of infections during therapy with Gilteritinb

Case control

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.

Drug: Gilteritinib

observational study to evaluate the incidence of infections during therapy with Gilteritinb

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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