Acute Myeloid LeukemiaNCT04460963
Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches
A study testing Adrenomedullin in people with Acute Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 5 sites in Italy.
Trial summary
The present study will be divided into 5 phases: 1. Collection of bone marrow and peripheral blood (PB) samples from AML patients at diagnosis; 2. Measurement of Midregional Proadrenomedullin (MR-proADM) plasma concentrations with an Immunoluminometric Assay of newly diagnosed AML patients not affected by concomitant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Adrenomedullin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 5 sitesItaly
- Study dates
- 9 Jun 2021to 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
- Patients with new diagnosis of primary or secondary AML.
- Participant is willing and able to give signed written informed consent according to ICH/EU/GCP and national local laws.
- Male or Female, aged >18 years.
Who cannot join
- Patients affected by concomitant cardiovascular disease , such as essential hypertension (any grade), chronic renal failure (creatinine>1.5 mg/dL), heart failure (any NYHA class), and peripheral arterial occlusive diseases, or sepsis.
- Patients affected by HIV, B or C hepatitis.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna
As Dell'Alto Adige, Ospedale Centrale Di Bolzano - Ematologia E Centro Trapianto Midollo Osseo
Bolzano
U.O. Oncoematologia IOV
Castelfranco Veneto
Ente Ecclesiastico Casa Sollievo Della Sofferenza - Ematologia
San Giovanni Rotondo
Uo Ematologia - Azienda Ulss N.2 Marca Trevigiana
Treviso
About this study
The present study will be divided into 5 phases:
- Collection of bone marrow and peripheral blood (PB) samples from AML patients at diagnosis;
- Measurement of Midregional Proadrenomedullin (MR-proADM) plasma concentrations with an Immunoluminometric Assay of newly diagnosed AML patients not affected by concomitant cardiovascular disease or sepsis.
- Analysis of exosomes and microvesicles derived from PB and bone marrow samples of AML patients and culture media collected from AML samples stimulated with ADM and/or ADM (22-52)
- Study of adrenomedullin system in leukemic stem cells (CD44+/CD38-/CD31+/Lin-) in order to define a correlated expression of ADM and ADM receptors (RAMPs, PAM) with adhesion molecules (CD31, CD38, CD44s, CD44v6), cell cycle regulatory proteins (p21, p27) and genes or molecules involved in the hematopoietic differentiation process (Cul5, CD11b, CD11c, CD66, CD14, CD15, PML-RARα)
- In vitro evaluation of ADM activity in the growth, maturation and trans-endothelial migration of blasts and/or fusion of leukemic cells with endothelial cells. To do this, leukemic cells will be alternatively cultured by using in vitro models of endosteal and vascular niches.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Adrenomedullin
- Keywords
- adrenomedullin
- 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.
AdrenomedullinOther
Adrenomedullin sample evaluation
| Study group | Role | What they receive |
|---|---|---|
| Biological evaluation | Other | Adrenomedullin evaluation at diagnosis at first CR and 1 year of follow-up Receives: Other: Adrenomedullin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of therapeutic potential of ADM inhibition on leukaemia stem cells
Rate estimation of the in vitro arrest of leukemic blasts proliferation by ADM inhibition.
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start9 Jun 2021
- Primary completionJun 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 Acute Myeloid LeukemiaStudies 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460963
- Sponsor's protocol ID
- AML2220
- Status last verified
- Mar 2026
- First submitted
- 25 Jun 2020
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches
- ClinicalTrials.gov ID
- NCT04460963
- Acronym / sponsor ID
- AML2220
- Conditions
- Acute Myeloid Leukemia
- Keywords
- adrenomedullin
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jul 2020 (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.
The present study will be divided into 5 phases:
- Collection of bone marrow and peripheral blood (PB) samples from AML patients at diagnosis;
- Measurement of Midregional Proadrenomedullin (MR-proADM) plasma concentrations with an Immunoluminometric Assay of newly diagnosed AML patients not affected by concomitant cardiovascular disease or sepsis.
- Analysis of exosomes and microvesicles derived from PB and bone marrow samples of AML patients and culture media collected from AML samples stimulated with ADM and/or ADM (22-52)
- Study of adrenomedullin system in leukemic stem cells (CD44+/CD38-/CD31+/Lin-) in order to define a correlated expression of ADM and ADM receptors (RAMPs, PAM) with adhesion molecules (CD31, CD38, CD44s, CD44v6), cell cycle regulatory proteins (p21, p27) and genes or molecules involved in the hematopoietic differentiation process (Cul5, CD11b, CD11c, CD66, CD14, CD15, PML-RARα)
- In vitro evaluation of ADM activity in the growth, maturation and trans-endothelial migration of blasts and/or fusion of leukemic cells with endothelial cells. To do this, leukemic cells will be alternatively cultured by using in vitro models of endosteal and vascular niches.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological evaluation | Other | Other: AdrenomedullinAdrenomedullin evaluation at diagnosis at first CR and 1 year of follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with new diagnosis of primary or secondary AML.
- Participant is willing and able to give signed written informed consent according to ICH/EU/GCP and national local laws.
- Male or Female, aged >18 years.
Key exclusion criteria (2 listed)
- Patients affected by concomitant cardiovascular disease , such as essential hypertension (any grade), chronic renal failure (creatinine>1.5 mg/dL), heart failure (any NYHA class), and peripheral arterial occlusive diseases, or sepsis.
- Patients affected by HIV, B or C hepatitis.
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 |
|---|---|---|
| AdrenomedullinAdrenomedullin sample evaluation | Other | Biological evaluation |
Primary outcome
Evaluation of therapeutic potential of ADM inhibition on leukaemia stem cells
Time frame: at 1 year
Rate estimation of the in vitro arrest of leukemic blasts proliferation by ADM inhibition.
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 6 Mar 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adrenomedullin in people with Acute Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 5 sites 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 2 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of therapeutic potential of ADM inhibition on leukaemia stem cells (time frame: at 1 year). 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 6 Mar 2026.