Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches

Acute Myeloid Leukemia Clinical Trial

Official title:

Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04460963
• Other study ID #: AML2220
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2021
• Est. completion date: June 2024

Study information

• Verified date: November 2022
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: Paola Fazi
• Phone: 0670390528
• Email: p.fazi[@]gimema.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia

Intervention

Other:
• Adrenomedullin
Adrenomedullin sample evaluation

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 1 year