Italian Non-Interventional Study of FLT3 Mutated AML Patients (FLAM)

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Status: Unknown

Conditions: AML; FLT3-ITD Mutation; FLT3-TKD Mutation

Treatments: Genetic: Clinical and Molecular data collection

Study type: Observational

Funder types: Other

Identifiers

NCT03547258

IRST204.01

Details and patient eligibility

About

This is an observational study involving a retrospective and prospective collection of clinical and molecular data regarding patients with AML with FLT3+ mutations

Full description

This is an observational study involving a retrospective and prospective collection of clinical and molecular data. Patients will follow their regular diagnostic and clinical practice. Thus, no additional procedure/blood withdrawal will be performed.

The study will be conducted as follows:

1. Retrospective phase: clinical and molecular data of AML patients with FLT3+ mutations detected at diagnosis or at any refractory/relapse state will be collected.
2. Prospective phase: clinical and molecular data of each new FLT3+ AML patient identified in participating centers at diagnosis or at any refractory/relapse state will be collected prospectively. Every effort will be done to include all consecutive patients, in order to avoid selection bias.

For patients with a mutation found at the time of disease relapse, any effort will be done to collect all the clinical and molecular information since the time of diagnosis.

The Primary objective of this study is to analyze how FLT3 mutational status evolve during the management of the disease looking at the percentage of patients with no FLT3 mutations at diagnosis who relapse with a new FLT3 mutation detected, and the percentage of FLT3 positive AML patients that after having obtained a Complete Remission relapse with FLT3 negative.

The secondary objective of the study is to investigate the association between different FLT3 mutations and the clinical, molecular and biological information.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. AML patients
2. Male or Female
3. Aged ≥ 18 years
4. FLT3 mutations (ITD or TKD) positive tests performed at diagnosis or at relapse.
5. Participant is willing and able to give informed consent for participation in the study.

Exclusion criteria

1. To be currently involved in experimental clinical protocol, or have been treated with experimental drugs are not exclusion criteria.

Trial design

800 participants in 1 patient group

AML patients

Description:

Clinical and Molecular data collection of AML Patients with FLT3 mutations (ITD or TKD)

Treatment:

Genetic: Clinical and Molecular data collection