NCT04801563

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

Allogeneic Transplantation in Patients With Myelodysplastic Syndrome Based on Risk According to Revised-International Prognostic Scoring System (R-IPSS)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Of Perugia · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• MDS and Allogeneic Stem Cell Transplantation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-09-20
• Primary completion: 2025-09-19
• Completion: 2025-09-19
• First posted: 2021-03-17
• Last updated: 2021-03-17

Locations

1 site across 1 country: Italy