AML, AdultNCT05839392
Novel Approaches to Target MECOM/EVI1 in AML
A study testing Biological characterization of AML with MECOM or atypical 3q26 rearrangements in people with AML, Adult, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Adult
- What is being tested?
- Biological characterization of AML with MECOM or atypical 3q26 rearrangements
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 13 Dec 2023to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AML with MECOM or atypical 3q26 rearrangements.
- Age ≥18.
- Signed written informed consent according to ICH/EU/GCP and national local laws.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Novel Approaches to Target MECOM/EVI1 in Acute Myeloid Leukemia
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.
- Conditions
- AML, Adult
- Being tested
- Biological characterization of AML with MECOM or atypical 3q26 rearrangements
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological characterization of AML with MECOM or atypical 3q26 rearrangementsBiological
Peripheral blood and bone marrow withdrawal
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of MECOM/EVI1 regulators or downstream effectors potentially druggable
To assess the number of regulators or effectors of MECOM/EVI1
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start13 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Roti, Principal investigator, Department of Medicine and Surgery, University of Parma, Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839392
- Sponsor's protocol ID
- AML2623
- Status last verified
- Dec 2023
- First submitted
- 21 Apr 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No