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RecruitingNCT05839392Updated Dec 29, 2023

Novel Approaches to Target MECOM/EVI1 in AML

An interventional study of Biological characterization of AML with MECOM or atypical 3q26 rearrangements in AML, Adult, sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-29.

Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • AML, Adult
03

In context

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto is the lead sponsor of 132 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Interventions

  • BiologicalBiological characterization of AML with MECOM or atypical 3q26 rearrangements

    Peripheral blood and bone marrow withdrawal

06

What researchers measure

Primary outcomes

  1. Identification of MECOM/EVI1 regulators or downstream effectors potentially druggable

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

    Time frame: At baseline

07

Study locations

1 of 1 sites recruiting
  • Ematologia
    Piacenza, Italy
    • Vallisa · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05839392
Lead sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Responsible party
Sponsor
First posted
May 3, 2023
Start date
Dec 13, 2023
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Dec 29, 2023

Study contacts

Paola Fazi
Contact
p.fazi@gimema.it
0670390528
Enrico Crea
Contact
e.crea@gimema.it
0670390514
Giovanni Roti
principal investigator · Department of Medicine and Surgery, University of Parma, Parma

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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