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

Overview

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.

Full Title of Study: “Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2024

Detailed 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.

Interventions

  • Other: bone marrow withdrawal
    • bone marrow samples evaluation

Arms, Groups and Cohorts

  • Other: Biological evaluation
    • evaluation of molecular changes in CD34+ blast cells at the time of relapse after allo-HSCT.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gruppo Italiano Malattie EMatologiche dell’Adulto
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Paola Fazi, 0670390528, p.fazi@gimema.it

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