Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04587856

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto, Bari, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bone marrow withdrawal

Other

bone marrow samples evaluation

Primary outcomes

  1. CD34+ blast cells modifications

    Time frame: at 24 months

    Difference in frequency distribution of CD34+ blast cells mutations between transplant and relapse.

Study contacts

Contact information is provided by the study sponsor or research team.

Enrico Crea

CONTACT

[email protected]

0670390514

Paola Fazi

CONTACT

[email protected]

0670390528

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 14, 2020
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.