RecruitingPhase 2

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

Sweden200 participantsStarted 2022-11-22

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Clinical event defined as relapse or death within 1 year from first MRD+ sample

Timeframe: Within 1 year from first MRD+ sample

Trial details

NCT IDNCT05788679

SponsorKarolinska University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Magnus Tobiasson, PhD

0046858580000 magnus.tobiasson@ki.se