Tests early treatment after stem cell transplant for myelodysplastic syndrome
Tests early treatment in adults with myelodysplastic syndrome who have residual disease after transplant.
Plain-language title generated from the registry record
Registry title: A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS
Key facts
- Where
- Stockholm, SwedenSee the site
- Phase
- Phase 2
Where in Sweden
- Department of Hematology, Karolinska University HospitalStockholm, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Karolinska University Hospital
- Trial code
- NCT05788679
- Record updated
- 5 December 2023
- Original description
The goal of this interventional study is to evaluate if pre-emptive intervention using Azacitidine and / or donor lymphocytes or tapering of immune suppression in measurable residual disease (MRD) positive subjects can prevent clinical relapse. Participants will undergo MRD surveillance and be subjected to intervention in case of MRD positivity. Results will be compared with NMDSG14B, part one, in which MRD was analyzed in included patients without recieving intervention.Read full original descriptionShow less
A Phase II Multicenter Single-armed Study Using Subject-specific Minimal Residual Disease Markers to Adopt Treatment After Allogeneic Stem Cell Transplantation for Subjects With Myelodysplastic Syndrome
The goal of this interventional study is to evaluate if pre-emptive intervention using Azacitidine and / or donor lymphocytes or tapering of immune suppression in measurable residual disease (MRD) positive subjects can prevent clinical relapse. Participants will undergo MRD surveillance and be subjected to intervention in case of MRD positivity. Results will be compared with NMDSG14B, part one, in which MRD was analyzed in included patients without recieving intervention.
Inclusion: Signed informed consent; Age ≥ 18 years; Subjects eligible for SCT; Subjects having the disease MDS, mixed myelodysplastic/myeloproliferative syndrome or AML with myelodysplasia related dysplasia and 20-29% marrow blasts; All female subjects of childbearing potential have to have negative pregnancy test within 2 weeks prior to inclusion to the study.
Exclusion: Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders; No traceable genetic aberration identified either in screening next generation sequencing panel or next generation sequencing panel performed at diagnosis; Mental inability, reluctance or language difficulties that results in difficulty understanding the meaning of study participation.