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Search / Trial NCT05788679

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

Launched by KAROLINSKA UNIVERSITY HOSPITAL · Mar 27, 2023

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to prevent relapse in patients with certain types of blood disorders, like Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Researchers want to see if treating patients who test positive for measurable residual disease (MRD) with medications like Azacitidine, donor lymphocytes, or reducing immune suppression can help keep the disease from coming back. Participants will be monitored closely for MRD and will receive treatment if they test positive, while the results will be compared to another study where patients did not receive this proactive treatment.

To be eligible for this trial, participants need to be at least 18 years old and have a diagnosis of MDS, mixed myelodysplastic/myeloproliferative syndrome, or AML with certain characteristics. They should not have uncontrolled health issues or significant mental barriers that would make it hard to understand the study. If you decide to participate, you will be part of a carefully monitored process that aims to improve outcomes for people with these serious conditions.

Gender

ALL

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

About Karolinska University Hospital

Karolinska University Hospital is a leading academic medical center in Sweden, renowned for its commitment to advanced healthcare research and innovative clinical practices. As a key sponsor of clinical trials, the hospital leverages its extensive expertise in medical research and collaboration with Karolinska Institutet, one of the world's foremost medical universities. The institution is dedicated to enhancing patient care through rigorous scientific investigation, focusing on a wide range of therapeutic areas. With a multidisciplinary approach and a strong emphasis on translational medicine, Karolinska University Hospital aims to bridge the gap between laboratory findings and clinical application, ultimately striving to improve health outcomes and advance medical knowledge.

Locations

Stockholm, , Sweden

Patients applied

0 patients applied

Trial Officials

Magnus Tobiasson, PhD

Principal Investigator

Karolinska University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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