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

Gruppo Italiano Malattie EMatologiche dell'Adulto388 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

388

Conditions

AML, Adult

Interventions

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

Observation of the test result.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Locations (24)

Outcomes

Primary Outcomes

Number of patients with the IDH mutations in AML at initial diagnosis.

Time frame: At two years from study entry.

Number of patients with the IDH mutations in AML at relapse.

Time frame: At three years from study entry.

Data from ClinicalTrials.gov

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