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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Stockholm, , Sweden
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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