Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Completed

Conditions: AML, Adult

Treatments: Genetic: IDH mutation test performed at diagnosis or relapse until January 31st, 2019.

Study type: Observational

Funder types: Other

Identifiers

NCT02986620

AML1516

Details and patient eligibility

About

This is a study where there are no interventions planned. Investigators will only collect data already in the patient's history and analyze it. Particularly, we are interested in molecular data from AML patients.

This means that patients will follow their regular diagnostic and clinical practice. The analyses will be conducted according to the routine diagnostic and clinical practice as well and no additional blood withdrawal will be performed.

Full description

The study will be conducted as follows:

1. Retrospective phase clinical and molecular data of patients analyzed for IDH1/2 mutations will be retrospectively collected in the centers that have already introduced IDH1/2 mutational screening in their practice from cases collected according to standard procedure (Ficoll and lysis in RLT buffer).
2. Prospective phase: each participating center already performing IDH1/2 mutational status on samples of their AML patients at diagnosis or relapse - on freshly isolate mononuclear cells from bone marrow and/or peripheral blood using Ficoll density gradient preparation - will prospectively collect the clinical and molecular data.

Enrollment: 388 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable);
• AML patients;
• Age ≥18;
• IDH mutation test performed at diagnosis or relapse until January 31st, 2019.

Exclusion criteria

• AML M3 subtype according to the FAB classification;

Trial design

388 participants in 1 patient group

AML patients

Description:

Adult AML patients with the IDH mutation test performed at diagnosis or relapse until January 31st, 2019.

Treatment:

Genetic: IDH mutation test performed at diagnosis or relapse until January 31st, 2019.