GilteRInf 2022 Study (Gilteritinib Related Infections)

NCT05791890 | Unknown DMC FDA Drug

• 1 other identifier: GilteRInf 2022
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

relapsed/refractory acute myeloid leukemia; FLT3+; FLT3 inhibitors; Gilteritinib; infections

Outcome Measures

Primary Outcomes (1)

• absolute infectious risk in patients treated with Gilteritinib, Infection events of grade 3 or more ( CTCAE v.5.0 )

  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

  24 months

Study Arms (2)

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

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

Interventions

Gilteritinib DRUG

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

Case control; Patients who receive or have received Gilteritinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Relapsed/refractory AML patients

You may qualify if:

• 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

You may not qualify if:

• \- Patients \< 18 years old

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Maria Ilaria Del Principe

Roma, RM, 00133, Italy

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Infections

Interventions

gilteritinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Maria Ilaria Del Principe, Prof

  University of Rome Tor Vergata

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 30, 2023
• Study Start: May 31, 2022
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

IT (1)