Novel Approaches to Target MECOM/EVI1 in AML

Not Applicable

Recruiting

• Conditions: AML, Adult

• Registration Number: NCT05839392
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary

This is an academic, no-profit, multicenter, biological, non-pharmacologic study aimed at characterizing genome, transcriptome and proteome of patients affected by AML with MECOM or atypical 3q26 rearrangements.

Detailed Description

This is an academic, no-profit, multicenter, biological, non-pharmacologic study aimed at characterizing genome, transcriptome and proteome of patients affected by AML with MECOM or atypical 3q26 rearrangements. To this end, BM samples and formalin fixed/paraffin-embedded BM biopsies will be collected at enrolment, before and after treatment, at relapse.

Study Timeline

• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-04-21
• Study First Posted: 2023-05-03
• Status Verified: 2023-12
• Study Start: 2023-12-13
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-29
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• AML with MECOM or atypical 3q26 rearrangements.
• Age ≥18.
• Signed written informed consent according to ICH/EU/GCP and national local laws.

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Identification of MECOM/EVI1 regulators or downstream effectors potentially druggable	At baseline	To assess the number of regulators or effectors of MECOM/EVI1

Trial Locations

Locations (1)

Ematologia; 🇮🇹 Piacenza, Italy