Allogeneic HSCT in MDS Patients Based on Risk According to R-IPSS

  • End date
    Sep 19, 2025
  • participants needed
  • sponsor
    University Of Perugia
Updated on 27 March 2021


An "intention-to-treat" study to evaluate the impact of allogeneic HSCT with Total Marrow and Lymphoid irradiation (TMLI), followed by Treg/Tcon adoptive immunotherapy, on overall survival in patients affected by Myelodysplastic Syndrome (MDS), according to IPSS-R.


MDS patients with Intermediate, High, or Very-High R-IPSS risk will be enrolled. Allogeneic stem cell transplantation with regulatory and conventional T cell adoptive immunotherapy will be proposed to eligible High and Very-High risk MDS patients. Intermediate risk MDS patients will be assessed for risk modification every six months and moved to transplant in case of increased risk. Intermediate risk MDS patients will be also evaluated for the presence of molecular alterations (TP53, ASXL1, RUNX1). Overall survival of the entire cohort will be assessed as primary endpoint. Incidence of Treatment Related Mortality, acute Graft versus Host Disease, chronic Graft versus Host Disease, Relapse will be also assessed.

Condition MDS and Allogeneic Stem Cell Transplantation
Treatment MDS and AlloHSCT
Clinical Study IdentifierNCT04801563
SponsorUniversity Of Perugia
Last Modified on27 March 2021


Yes No Not Sure

Inclusion Criteria

Patients affected by Myelodysplastic Syndrome with IPSS-R INT, HIGH or VERY HIGH
Age <71 years
Signature of the informed consent

Exclusion Criteria

Patients affected by Myelodysplastic Syndrome with IPSS-R VERY LOW or LOW
Patients affected by Myelodysplastic Syndrome/Myeloproliferative Neoplasm
Age >70 years
No signature of the informed consent
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