A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS
Recruiting now · Phase 2
Conditions studied: Myelodysplastic Syndromes, Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts, Mixed Myelodysplastic/Myeloproliferative Disease
In brief
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.
Key facts
- Study ID
- NCT05788679
- Run by
- Karolinska University Hospital
- People needed
- 200
- Starts
- 2022-11-22
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2023-12-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Department of Hematology, Karolinska University Hospital — Stockholm, Sweden (enrolling)
Full record on ClinicalTrials.gov
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