Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06845592 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this 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
StatusRecruiting
PhaseNot applicable
Started2025-02-25
View on ClinicalTrials.gov ↗

Amendment history

2025-03-01
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-02→confirmed 2025-02-25
Study sites0→1
2025-02-26
minor
Study Status, Outcome Measures v1
Secondary endpoints3 entries, revised
EngraftmentNumber of participants that have reached engraftment 45 days after HSCT GradeNumber of participants that developed grade ≥ 2 acute GvHD ChronicNumber of participants free from chronic GvHD 2 years after HSCT
Primary endpoints1 entry, revised
DiseaseNumber relapseof participants free from disease 2 years after HSCT
2025-02-19
minor
Original filing
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.
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