Molecular Characterization of Patients With Acute Myeloid Leukemia and the Impact of Clonal Evolution in the Response to Therapeutic Treatments

Recruiting

• Conditions: Myeloid Leukemia, Acute

• Registration Number: NCT06764459
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

This study aims to analyze patients with mutated FLT3 AML treated with specific therapy by means of molecular characterization methods, to identify the presence of clones and subclones at onset and to be able to follow their evolution during therapeutic treatment.

Detailed Description

This study aims to analyze patients with mutated FLT3 AML treated with specific therapy by means of single-cell molecular characterization methods, to identify the presence of clones and subclones at onset and to be able to follow their evolution during therapeutic treatment. In this way, it is possible to study how the mutational profile varies under therapeutic pressure and identify any alterations responsible for resistance. It will thus be possible to define a panel of new molecular markers to be included in the diagnostic routine to identify early patients refractory/resistant to treatment with FLT3 inhibitors and thus improve the therapeutic approach of these patients.

Study Timeline

• Study Start: 2023-03-15
• Status Verified: 2024-12
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-07
• Study First Posted: 2025-01-08
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• FLT3 mutated

Exclusion Criteria

• Respoder to therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Refractoriness to therapy	At the end of the enrollment 3 years	Selected patients, as they are mutated in FLT3, following therapy with specific inhibitors must show refractoriness to treatment in order to continue the study and investigate in single cell the presence of clones or subclones responsible for any relapses.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola; 🇮🇹 Bologna, Italy