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

October 21, 2024 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bari, Italy
        • Recruiting
        • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
        • Contact:
      • Firenze, Italy
        • Recruiting
        • Unità di Ricerca e di Malattie del sangue - Ematologia S. Luca Vecchio
        • Contact:
          • Valeria Santini
      • Genova, Italy
        • Recruiting
        • AOU San Martino-IST-Ematologia 1
        • Contact:
          • Carmela Di Grazia
      • Perugia, Italy
        • Recruiting
        • Sezione di Ematologia - Ospedale S.Maria della Misericordia
        • Contact:
          • Cristina Mecucci
      • Roma, Italy
        • Recruiting
        • Policlinico Tor Vergata
        • Contact:
          • Maria Teresa Voso
      • Roma, Italy
        • Recruiting
        • Dip. di Medicina Trasl. E di Precisione - U.O.C. Ematologia
        • Contact:
          • Massimo Breccia
      • Rozzano, Italy
        • Recruiting
        • Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Biological evaluation
evaluation of molecular changes in CD34+ blast cells at the time of relapse after allo-HSCT.
Other: bone marrow withdrawal
bone marrow samples evaluation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2021

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

October 12, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDS0620

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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