Clinical Trial

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

Study acronym: SHARP
Recruiting
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-02-19; most recent amendment 2025-03-01.
Status change: Not Yet Recruiting → Recruiting 2025-03-01
Trial Details
NCT Number NCT06845592
Lead Sponsor University Of Perugia
Conditions Acute Myeloid Leukaemia (AML), Acute Lymphoblastic Leukemia ALL, High Risk Leukaemia, Leukaemia Relapse
Enrollment 51 participants
Start Date 2025-02-25
Primary Completion 2029-01 (estimated)
Study Completion 2031-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-04