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Novel Approaches to Target MECOM/EVI1 in AML

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05839392
Collaborator
(none)
24
Enrollment
36
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Biological characterization of AML with MECOM or atypical 3q26 rearrangements
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Novel Approaches to Target MECOM/EVI1 in Acute Myeloid Leukemia
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Sep 1, 2026

Outcome Measures

Primary Outcome Measures

  1. Identification of MECOM/EVI1 regulators or downstream effectors potentially druggable [At baseline]

    To assess the number of regulators or effectors of MECOM/EVI1

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Giovanni Roti, Department of Medicine and Surgery, University of Parma, Parma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT05839392
Other Study ID Numbers:
  • AML2623
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 3, 2023