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Clinical Trials in Italy / NCT04587856
Recruiting Not applicable

Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in MDS Patients

NCT04587856 · tracked via the Priya Life Science Italy tracker
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Phase
Not applicable
Started
2021-02-12
Last updated
2024-10-22

Condition(s) studied

Myelodysplastic Syndromes

Investigational drug(s) / intervention(s)

bone marrow withdrawal

bone marrow withdrawal: bone marrow samples evaluation

Study summary

This is a biological study for adult MDS patients who undergo HSCT procedure. Viable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence. CD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant to study genomic and transcriptomic changes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of MDS according to 2016 WHO criteria * Aged 18y or older * Patients who will receive allogeneic stem cell transplantation (HSCT) * Signed written informed consent according to ICH/EU/GCP and national local laws Exclusion Criteria: * Second HSCT procedure.

Primary outcome measure(s)

  • CD34+ blast cells modifications — at 24 months
    Difference in frequency distribution of CD34+ blast cells mutations between transplant and relapse.

Trial sites (7)

FacilityCityRegionStatus
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto Bari Italy Recruiting
Unità di Ricerca e di Malattie del sangue - Ematologia S. Luca Vecchio Florence Italy Recruiting
AOU San Martino-IST-Ematologia 1 Genova Italy Recruiting
Sezione di Ematologia - Ospedale S.Maria della Misericordia Perugia Italy Recruiting
Dip. di Medicina Trasl. E di Precisione - U.O.C. Ematologia Roma Italy Recruiting
Policlinico Tor Vergata Roma Italy Recruiting
Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia Rozzano Italy Recruiting

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Other trials for the same condition

Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA Recruiting
A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS) Active, not recruiting
Eltrombopag for the Treatment of Thrombocytopenia Due to Low- and Intermediate Risk Myelodysplastic Syndromes Active, not recruiting
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) Recruiting
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions Recruiting
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 NCT04587856 on ClinicalTrials.gov ↗ ← All trials in Italy