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NCT04587856 Clinical Trial

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

Myelodysplastic Syndromes Clinical Trial

Official title:
Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04587856
Other study ID # MDS0620
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 12, 2021
Est. completion date March 2024

Study information
Verified date January 2024
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone 0670390528
Email p.fazi@gimema.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

This is a biological study for adult MDS patients who undergo HSCT procedure.The research is focused on the study of biological mechanisms of disease relapse after HSCT in MDS to provide the rationale to develop pre-emptive strategies in patients with high risk of transplant failure. 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 by using Single-cell sequencing. To study genomic and transcriptomic changes in CD34+ blast cells at disease relapse after HSCT will be used TARGET-seq in parallel with unbiased whole-transcriptome analysis.

Recruitment information / eligibility
Status Recruiting
Enrollment 38
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• bone marrow withdrawal
bone marrow samples evaluation

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

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