Myelodysplastic SyndromesNCT04587856
Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in MDS Patients
A study testing bone marrow withdrawal in people with Myelodysplastic Syndromes, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 7 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- bone marrow withdrawal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 7 sitesItaly
- Study dates
- 12 Feb 2021to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Second HSCT procedure.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Recruiting
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari
Pellegrino Musto, pellegrino.musto@uniba.it
- Recruiting
Unità di Ricerca e di Malattie del sangue - Ematologia S. Luca Vecchio
Florence
Valeria Santini
- Recruiting
AOU San Martino-IST-Ematologia 1
Genova
Carmela Di Grazia
- Recruiting
Sezione di Ematologia - Ospedale S.Maria della Misericordia
Perugia
Cristina Mecucci
- Recruiting
Dip. di Medicina Trasl. E di Precisione - U.O.C. Ematologia
Roma
Massimo Breccia
- Recruiting
Policlinico Tor Vergata
Roma
Maria Teresa Voso
- Recruiting
Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia
Rozzano
Matteo E Della Porta, matteo.della_porta@hunimed.eu
About this study
Official title: Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome
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.
Read the 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.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- bone marrow withdrawal
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone marrow withdrawalOther
bone marrow samples evaluation
| Study group | Role | What they receive |
|---|---|---|
| Biological evaluation | Other | evaluation of molecular changes in CD34+ blast cells at the time of relapse after allo-HSCT. Receives: Other: bone marrow withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD34+ blast cells modifications
Difference in frequency distribution of CD34+ blast cells mutations between transplant and relapse.
Measured: at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start12 Feb 2021
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587856
- Sponsor's protocol ID
- MDS0620
- Status last verified
- Oct 2024
- First submitted
- 24 Sep 2020
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT04587856
- Acronym / sponsor ID
- MDS0620
- Conditions
- Myelodysplastic Syndromes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological evaluation | Other | Other: bone marrow withdrawalevaluation of molecular changes in CD34+ blast cells at the time of relapse after allo-HSCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Second HSCT procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone marrow withdrawalbone marrow samples evaluation | Other | Biological evaluation |
Primary outcome
CD34+ blast cells modifications
Time frame: at 24 months
Difference in frequency distribution of CD34+ blast cells mutations between transplant and relapse.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bone marrow withdrawal in people with Myelodysplastic Syndromes, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD34+ blast cells modifications (time frame: at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.