NCT06845592

Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia

SHARP - Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: University Of Perugia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is a monocentric, interventional study that evaluates the efficacy of allogeneic HLA-matched or haploidentical transplantation consisting of an irradiation-based conditioning regimen coupled with donor Treg/Tcon adoptive immunotherapy for high-risk acute leukemia patients.

Conditions

• Acute Myeloid Leukaemia (AML)
• Acute Lymphoblastic Leukemia ALL
• High Risk Leukaemia
• Leukaemia Relapse

Interventions

Type	Name	Description
RADIATION	total marrow/lymphoid irradiation	Combination of 20 Gy TMLI with Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation

Timeline

• Start date: 2025-02-25
• Primary completion: 2029-01-01
• Completion: 2031-01-01
• First posted: 2025-02-25
• Last updated: 2025-03-04

Locations

1 site across 1 country: Italy