Molecular Mechanisms of Disease Relapse After Allogenic S... | NCT04587856

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

NCT04587856

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status

Recruiting

Last Update Posted

Oct 22, 2024Actual

Enrollment

38Estimated

Phase

Not Applicable

Conditions

Myelodysplastic Syndromes

Interventions

bone marrow withdrawal

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 12, 2021Actual

Primary Completion Date

Mar 2025Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Sep 24, 2020

First Submission Date that Met QC Criteria

Oct 12, 2020

First Posted Date

Oct 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2024

Last Update Posted Date

Oct 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biological evaluation	Other	evaluation of molecular changes in CD34+ blast cells at the time of relapse after allo-HSCT.	Other: bone marrow withdrawal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bone marrow withdrawal	Other	bone marrow samples evaluation	Biological evaluation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CD34+ blast cells modifications	Difference in frequency distribution of CD34+ blast cells mutations between transplant and relapse.	at 24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paola Fazi	Contact	0670390528		p.fazi@gimema.it
Enrico Crea	Contact	0670390514		e.crea@gimema.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto	Recruiting	Bari			Italy

Condition Browse Module

MeSH Terms

ID	Term
D009190	Myelodysplastic Syndromes

Ancestor Terms

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided