A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS

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 Criteria:

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 Criteria:

• 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