NCT05788679 A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS
| NCT ID | NCT05788679 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Karolinska University Hospital |
| Condition | Myelodysplastic Syndromes |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-11-22 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2022-11-22 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Magnus Tobiasson, PhD
PRINCIPAL INVESTIGATOR
Karolinska University Hospital
Frequently Asked Questions
Who can join the NCT05788679 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myelodysplastic Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05788679 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05788679 currently recruiting?
Yes, NCT05788679 is actively recruiting participants. Contact the research team at magnus.tobiasson@ki.se for enrollment information.
Where is the NCT05788679 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05788679 clinical trial?
NCT05788679 is sponsored by Karolinska University Hospital. The principal investigator is Magnus Tobiasson, PhD at Karolinska University Hospital. The trial plans to enroll 200 participants.