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

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ClinicalTrials.gov Identifier: NCT04587856
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Other: bone marrow withdrawal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome
Actual Study Start Date : February 12, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. CD34+ blast cells modifications [ Time Frame: at 24 months ]
    Difference in frequency distribution of CD34+ blast cells mutations between transplant and relapse.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587856


Contacts
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Contact: Paola Fazi 0670390528 p.fazi@gimema.it
Contact: Enrico Crea 0670390514 e.crea@gimema.it

Locations
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Italy
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto Recruiting
Bari, Italy
Contact: Pellegrino Musto       pellegrino.musto@uniba.it   
Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia Recruiting
Rozzano, Italy
Contact: Matteo E Della Porta       matteo.della_porta@hunimed.eu   
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT04587856    
Other Study ID Numbers: MDS0620
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms