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Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04460963
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : June 14, 2021
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Other: Adrenomedullin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches
Actual Study Start Date : June 9, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
Biological evaluation
Adrenomedullin evaluation at diagnosis at first CR and 1 year of follow-up
Other: Adrenomedullin
Adrenomedullin sample evaluation

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04460963

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Contact: Paola Fazi 0670390528
Contact: Enrico Crea 0670390514

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U.O. Oncoematologia IOV Recruiting
Castelfranco Veneto, Italy
Contact: Michele Gottardi         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto Identifier: NCT04460963    
Other Study ID Numbers: AML2220
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Additional relevant MeSH terms:
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Antihypertensive Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Vasodilator Agents
Protective Agents