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A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS
Sponsor: Karolinska University Hospital
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2022-11-22
Completion Date
2026-12
Last Updated
2023-12-05
Healthy Volunteers
No
Conditions
Interventions
Azacitidine
Azacitidine
Donor lymphocytes
Donor lymphocytes in patients without immune suppression
Tapering of immune suppression
Tapering of immune suppression in patients who are on immune suppressive drugs
Locations (1)
Department of Hematology, Karolinska University Hospital
Stockholm, Sweden