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

Primary Purpose

Myelodysplastic Syndromes

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
bone marrow withdrawal
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Myelodysplastic Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Aou Consorziale Policlinico - Bari - Uo Ematologia Con TrapiantoRecruiting
  • Unità di Ricerca e di Malattie del sangue - Ematologia S. Luca VecchioRecruiting
  • AOU San Martino-IST-Ematologia 1Recruiting
  • Sezione di Ematologia - Ospedale S.Maria della MisericordiaRecruiting
  • Dip. di Medicina Trasl. E di Precisione - U.O.C. EmatologiaRecruiting
  • Policlinico Tor VergataRecruiting
  • Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed EmatologiaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Biological evaluation

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 24, 2020
Last Updated
October 10, 2022
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
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1. Study Identification

Unique Protocol Identification Number
NCT04587856
Brief Title
Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in MDS Patients
Official Title
Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biological evaluation
Arm Type
Other
Arm Description
evaluation of molecular changes in CD34+ blast cells at the time of relapse after allo-HSCT.
Intervention Type
Other
Intervention Name(s)
bone marrow withdrawal
Intervention Description
bone marrow samples evaluation
Primary Outcome Measure Information:
Title
CD34+ blast cells modifications
Description
Difference in frequency distribution of CD34+ blast cells mutations between transplant and relapse.
Time Frame
at 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Fazi
Phone
0670390528
Email
p.fazi@gimema.it
First Name & Middle Initial & Last Name or Official Title & Degree
Enrico Crea
Phone
0670390514
Email
e.crea@gimema.it
Facility Information:
Facility Name
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
City
Bari
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pellegrino Musto
Email
pellegrino.musto@uniba.it
Facility Name
Unità di Ricerca e di Malattie del sangue - Ematologia S. Luca Vecchio
City
Firenze
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeria Santini
Facility Name
AOU San Martino-IST-Ematologia 1
City
Genova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmela Di Grazia
Facility Name
Sezione di Ematologia - Ospedale S.Maria della Misericordia
City
Perugia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Mecucci
Facility Name
Dip. di Medicina Trasl. E di Precisione - U.O.C. Ematologia
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Breccia
Facility Name
Policlinico Tor Vergata
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Teresa Voso
Facility Name
Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia
City
Rozzano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo E Della Porta
Email
matteo.della_porta@hunimed.eu

12. IPD Sharing Statement

Learn more about this trial

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

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