Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04460963

Enrollment

Registered

2020-07-08

Start date

2021-06-09

Completion date

2026-12-01

Last updated

2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

adrenomedullin

Brief 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 cardiovascular disease or sepsis. 3. 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) 4. 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) 5. 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.

Interventions

OTHERAdrenomedullin

Adrenomedullin sample evaluation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with new diagnosis of primary or secondary AML. 2. Participant is willing and able to give signed written informed consent according to ICH/EU/GCP and national local laws. 3. Male or Female, aged \>18 years.

Exclusion criteria

1. 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. 2. Patients affected by HIV, B or C hepatitis.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of therapeutic potential of ADM inhibition on leukaemia stem cells	at 1 year	Rate estimation of the in vitro arrest of leukemic blasts proliferation by ADM inhibition.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026