Understanding disease relapse after stem cell transplantation in MDS patients
Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome
This study is trying to understand why some adults with Myelodysplastic Syndromes relapse after getting a stem cell transplant, by looking closely at their bone marrow samples before and after the transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto Academic / other |
| Locations | 7 sites (Bari and 6 other locations) |
| Trial ID | NCT04587856 on ClinicalTrials.gov |
What this trial studies
This study investigates the biological mechanisms behind disease relapse in adult patients with Myelodysplastic Syndromes (MDS) who undergo allogeneic stem cell transplantation (HSCT). It involves collecting and cryopreserving viable bone marrow samples from patients before and after transplantation, specifically at the time of clinical disease recurrence. The research focuses on comparing CD34+ blast cells at relapse with those collected prior to the transplant using advanced genomic and transcriptomic analysis techniques, including Single-cell sequencing and TARGET-seq. The ultimate goal is to develop pre-emptive strategies for patients at high risk of transplant failure.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 and older diagnosed with Myelodysplastic Syndromes who are scheduled to receive allogeneic stem cell transplantation.
Not a fit: Patients who have undergone a second HSCT procedure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing disease relapse in MDS patients after stem cell transplantation.
How similar studies have performed: While this approach is focused on a specific patient population, similar studies investigating disease mechanisms post-transplant have shown promise in understanding relapse, making this research both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bari and 6 other locations
- 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)
Study contacts
- Study coordinator: Paola Fazi
- Email: p.fazi@gimema.it
- Phone: 0670390528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.