Allogeneic HSCT in MDS Patients Based on Risk According to R-IPSS
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: SINGLE ARM
|
Other: MDS and AlloHSCT
Allogeneic stem cell transplantation, based on TMLI and followed by infusion of donor regulatory T cells and conventional T cells and purified donor CD34+ hematopoietic stem cells
|
Outcome Measures
Primary Outcome Measures
- overall survival [4 years]
We will evaluate overall survival in patients with intermediate/High/very-High risk MDS
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients affected by Myelodysplastic Syndrome with IPSS-R INT, HIGH or VERY HIGH;
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Age <71 years;
-
Signature of the informed consent.
Exclusion Criteria:
-
Patients affected by Myelodysplastic Syndrome with IPSS-R VERY LOW or LOW;
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Patients affected by Myelodysplastic Syndrome/Myeloproliferative Neoplasm;
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Age >70 years;
-
No signature of the informed consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Perugia | Perugia | PG | Italy | 06132 |
Sponsors and Collaborators
- University Of Perugia
Investigators
- Principal Investigator: Andrea Velardi, MD, University Of Perugia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 03/19