Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04460963 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 6, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jun 2024 to Jun 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 2024 to Dec 2026
    • Site details revised at 5 of 5 sites
    v5
  2. Study sites: 2 to 5v4
  3. Study sites: 1 to 2v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Oct 2023 to Jun 2024
    • Start date changed from estimate of Oct 2020 to Jun 9, 2021
    • Study sites: 0 to 1
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04460963
Lead Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov