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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approaches to Target MECOM/EVI1 in Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05839392
- Acronym / sponsor ID
- AML2623
- Conditions
- AML, Adult
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AML with MECOM or atypical 3q26 rearrangements.
- Age ≥18.
- Signed written informed consent according to ICH/EU/GCP and national local laws.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological characterization of AML with MECOM or atypical 3q26 rearrangementsPeripheral blood and bone marrow withdrawal | Biological | – |
Primary outcome
Identification of MECOM/EVI1 regulators or downstream effectors potentially druggable
Time frame: At baseline
To assess the number of regulators or effectors of MECOM/EVI1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanni Roti principal investigator
Department of Medicine and Surgery, University of Parma, Parma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of MECOM/EVI1 regulators or downstream effectors potentially druggable (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.