Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Using personalized MRD to guide treatment after stem cell transplant for MDS patients

Official title: 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

Run by Karolinska University Hospital · NCT05788679 · Data updated 2026-11-12

This study is testing if giving personalized treatments like Azacitidine or donor lymphocytes can help prevent relapse in people with myelodysplastic syndromes after they’ve had a stem cell transplant.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorKarolinska University Hospital
Academic / other
Locations1 site (Stockholm)
StatusRecruiting
StartedNovember 22, 2022
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedDecember 5, 2023
Trial IDNCT05788679 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with MDS or related conditions who are eligible for stem cell transplantation.

Probably not a fit

Patients without traceable genetic aberrations or those with uncontrolled medical conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to assess whether pre-emptive treatment with Azacitidine and/or donor lymphocytes, or tapering of immune suppression, can prevent relapse in patients with measurable residual disease (MRD) after hematopoietic stem cell transplantation (HSCT) for myelodysplastic syndromes (MDS) and related conditions. Participants will be monitored for MRD positivity and will receive interventions accordingly. The outcomes will be compared to a previous study where MRD was analyzed without intervention, providing insights into the effectiveness of this personalized approach.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of relapse in MDS patients after HSCT.

How similar studies have gone: Previous studies have shown promise in using MRD monitoring for treatment decisions, but this specific approach is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Department of Hematology, Karolinska University Hospital
    Stockholm, Sweden
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.