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Clinical Trials in Italy / NCT04460963
Active, not recruiting Not applicable

Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches

NCT04460963 · tracked via the Priya Life Science Italy tracker
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Phase
Not applicable
Started
2021-06-09
Last updated
2026-03-06

Condition(s) studied

Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

Adrenomedullin

Adrenomedullin: Adrenomedullin sample evaluation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Policlinico S. Orsola-Malpighi - Uoc Ematologia Bologna Italy
As Dell'Alto Adige, Ospedale Centrale Di Bolzano - Ematologia E Centro Trapianto Midollo Osseo Bolzano Italy
U.O. Oncoematologia IOV Castelfranco Veneto Italy
Ente Ecclesiastico Casa Sollievo Della Sofferenza - Ematologia San Giovanni Rotondo Italy
Uo Ematologia - Azienda Ulss N.2 Marca Trevigiana Treviso Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04460963 on ClinicalTrials.gov ↗ ← All trials in Italy