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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska University Hospital

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

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

Karolinska University Hospital

Lead sponsor

Nordic MDS Group

Collaborator