About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
No traceable genetic aberration identified either in screening next generation sequencing panel or next generation sequencing panel performed at diagnosis
Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders
Mental inability, reluctance or language difficulties that results in difficulty understanding the meaning of study participation
Trial design
Treatments tested in this trial
- Azacitidine
- Donor lymphocytes
- Tapering of immune suppression
Treatment groups
Sponsors and collaborators
Karolinska University Hospital
Lead sponsor
Nordic MDS Group
Collaborator