NCT04587856

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

February 12, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

4 years

First QC Date

September 24, 2020

Last Update Submit

October 21, 2024

Conditions

Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

  • CD34+ blast cells modifications

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

    at 24 months

Study Arms (1)

Biological evaluation

OTHER

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

Other: bone marrow withdrawal

Interventions

bone marrow withdrawalOTHER

bone marrow samples evaluation

Biological evaluation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Second HSCT procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto

Bari, Italy

RECRUITING

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

Florence, Italy

RECRUITING

AOU San Martino-IST-Ematologia 1

Genova, Italy

RECRUITING

Sezione di Ematologia - Ospedale S.Maria della Misericordia

Perugia, Italy

RECRUITING

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

Roma, Italy

RECRUITING

Policlinico Tor Vergata

Roma, Italy

RECRUITING

Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia

Rozzano, Italy

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Paola Fazi

CONTACT

0670390528p.fazi@gimema.it

Enrico Crea

CONTACT

0670390514e.crea@gimema.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2020

First Posted

October 14, 2020

Study Start

February 12, 2021

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

October 22, 2024

Record last verified: 2024-10

Locations

IT(7)