NCT05839392

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Dec 2023Dec 2026

First Submitted

Initial submission to the registry

April 21, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

December 13, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

3 years

First QC Date

April 21, 2023

Last Update Submit

December 22, 2023

Conditions

AML, Adult

Outcome Measures

Primary Outcomes (1)

  • Identification of MECOM/EVI1 regulators or downstream effectors potentially druggable

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

    At baseline

Interventions

Biological characterization of AML with MECOM or atypical 3q26 rearrangementsBIOLOGICAL

Peripheral blood and bone marrow withdrawal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ematologia

Piacenza, Italy

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

MDS1 and EVI1 Complex Locus Protein

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

DNA-Binding ProteinsProteinsAmino Acids, Peptides, and ProteinsProto-Oncogene ProteinsOncogene ProteinsNeoplasm ProteinsTranscription Factors

Study Officials

  • Giovanni Roti

    Department of Medicine and Surgery, University of Parma, Parma

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Fazi

CONTACT

0670390528p.fazi@gimema.it

Enrico Crea

CONTACT

0670390514e.crea@gimema.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 3, 2023

Study Start

December 13, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 29, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)