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

NCT ID: NCT04587856

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-12

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myelodysplastic Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Biological evaluation

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

Group Type OTHER

bone marrow withdrawal

Intervention Type OTHER

bone marrow samples evaluation

Interventions

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bone marrow withdrawal

bone marrow samples evaluation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto

Bari, , Italy

Site Status RECRUITING

Unità di Ricerca e di Malattie del sangue - Ematologia S. Luca Vecchio

Florence, , Italy

Site Status RECRUITING

AOU San Martino-IST-Ematologia 1

Genova, , Italy

Site Status RECRUITING

Sezione di Ematologia - Ospedale S.Maria della Misericordia

Perugia, , Italy

Site Status RECRUITING

Dip. di Medicina Trasl. E di Precisione - U.O.C. Ematologia

Roma, , Italy

Site Status RECRUITING

Policlinico Tor Vergata

Roma, , Italy

Site Status RECRUITING

Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia

Rozzano, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paola Fazi

Role: CONTACT

0670390528

Enrico Crea

Role: CONTACT

0670390514

Facility Contacts

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Pellegrino Musto

Role: primary

Valeria Santini

Role: primary

Carmela Di Grazia

Role: primary

Cristina Mecucci

Role: primary

Massimo Breccia

Role: primary

Maria Teresa Voso

Role: primary

Matteo E Della Porta

Role: primary

Other Identifiers

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MDS0620

Identifier Type: -

Identifier Source: org_study_id

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