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RECRUITING
NCT05788679
PHASE2

A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS

Sponsor: Karolinska University Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

Azacitidine

Azacitidine

OTHER

Donor lymphocytes

Donor lymphocytes in patients without immune suppression

OTHER

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