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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 1 site (Stockholm) |
| Status | Recruiting |
| Started | November 22, 2022 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | December 5, 2023 |
| Trial ID | NCT05788679 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
- Principal investigator: Magnus Tobiasson, PhD — Karolinska University Hospital
- Study coordinator: Magnus Tobiasson, PhD
- Email: magnus.tobiasson@ki.se
- Phone: 0046858580000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Age-stratified conditioning regimens to improve outcomes in haploidentical stem cell transplant for myelodysplastic syndrome
This study tests two conditioning regimens in adults with MDS undergoing haploidentical stem cell transplant to see how age affects outcomes over one year.
-
FXS0683 in relapsed or refractory blood cancers
This first‑in‑human study tests FXS0683 in adults with relapsed or refractory B‑cell lymphoma, AML, MDS, or ALL to see if it is safe, how the drug behaves in the body, and whether it shows any antitumor activity.
-
Brain network changes in adults with anemia measured by fNIRS
This project will use functional near-infrared spectroscopy (fNIRS) to see if brain network connections are altered in adults aged 18–65 who have anemia.
-
Cord blood transplant for children and young adults with blood cancers.
This study will test whether a cord blood transplant given as a first or second transplant can help children and young adults with leukemia, myelodysplasia, or lymphoma who lack a matched donor.
-
Reduced-intensity donor stem cell transplant with treosulfan/fludarabine and post-transplant cyclophosphamide for leukemia and MDS
This trial tests a lower-intensity donor stem cell transplant using treosulfan plus fludarabine with post-transplant cyclophosphamide to try to reduce toxicity and prevent graft-versus-host disease in people aged 2–75 with acute leukemias or myelodysplastic syndromes.
-
Electronic mindfulness-based music therapy for patients receiving stem cell transplantation
This trial tests an eHealth mindfulness-based music therapy to see if it improves quality of life and reduces symptoms for adults undergoing stem cell transplantation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.