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

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Enrolling

Conditions: Myelodysplastic Syndromes

Treatments: Other: bone marrow withdrawal

Study type: Interventional

Funder types: Other

Identifiers

NCT04587856

MDS0620

Details and patient eligibility

About

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 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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Biological evaluation

Other group

Description:

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

Treatment:

Other: bone marrow withdrawal