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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05839392
Other study ID # AML2623
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 13, 2023
Est. completion date December 2026

Study information

Verified date December 2023
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone 0670390528
Email p.fazi@gimema.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Biological:
Biological characterization of AML with MECOM or atypical 3q26 rearrangements
Peripheral blood and bone marrow withdrawal

Locations

Country Name City State
Italy Ematologia Piacenza

Sponsors (1)

Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of MECOM/EVI1 regulators or downstream effectors potentially druggable To assess the number of regulators or effectors of MECOM/EVI1 At baseline
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