Novel Approaches to Target MECOM/EVI1 in AML

NCT ID: NCT05839392

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-13

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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AML, Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Biological characterization of AML with MECOM or atypical 3q26 rearrangements

Peripheral blood and bone marrow withdrawal

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanni Roti

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine and Surgery, University of Parma, Parma

Locations

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Ematologia

Piacenza, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paola Fazi

Role: CONTACT

Phone: 0670390528

Email: [email protected]

Enrico Crea

Role: CONTACT

Phone: 0670390514

Email: [email protected]

Facility Contacts

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Vallisa

Role: primary

Other Identifiers

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AML2623

Identifier Type: -

Identifier Source: org_study_id