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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria expanded, about 1 wordv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05788679
Lead Sponsor Karolinska University Hospital
Collaborators: Nordic MDS Group
Conditions
(from sponsor)		 Myelodysplastic Syndromes, Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts, Mixed Myelodysplastic/Myeloproliferative Disease
Related terms Myelodysplastic Syndromes, Myeloproliferative Disorders
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov