Using personalized MRD to guide treatment after stem cell transplant for MDS patients
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
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 |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05788679 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with MDS or related conditions who are eligible for stem cell transplantation.
Not a fit: Patients without traceable genetic aberrations or those with uncontrolled medical conditions may not benefit from this study.
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 performed: Previous studies have shown promise in using MRD monitoring for treatment decisions, but this specific approach is novel.
Eligibility criteria
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 this trial is running
Stockholm
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.