Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches

Last updated: March 4, 2026
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Acute Myeloid Leukemia

Platelet Disorders

Leukemia

Treatment

Adrenomedullin

Clinical Study ID

NCT04460963
AML2220
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 toICH/EU/GCP and national local laws.

  3. Male or Female, aged >18 years.

Exclusion

Exclusion Criteria:

  1. Patients affected by concomitant cardiovascular disease , such as essentialhypertension (any grade), chronic renal failure (creatinine>1.5 mg/dL), heartfailure (any NYHA class), and peripheral arterial occlusive diseases, or sepsis.

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

Study Design

Total Participants: 72
Treatment Group(s): 1
Primary Treatment: Adrenomedullin
Phase:
Study Start date:
June 09, 2021
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Policlinico S. Orsola-Malpighi - Uoc Ematologia

    Bologna,
    Italy

    Site Not Available

  • As Dell'Alto Adige, Ospedale Centrale Di Bolzano - Ematologia E Centro Trapianto Midollo Osseo

    Bolzano,
    Italy

    Site Not Available

  • U.O. Oncoematologia IOV

    Castelfranco Veneto,
    Italy

    Site Not Available

  • Ente Ecclesiastico Casa Sollievo Della Sofferenza - Ematologia

    San Giovanni Rotondo,
    Italy

    Site Not Available

  • Uo Ematologia - Azienda Ulss N.2 Marca Trevigiana

    Treviso,
    Italy

    Site Not Available

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