NCT06845592Recruiting
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
Source: ClinicalTrials.gov · Last updated 4 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- First submitted
- 14 Feb 2025
- Start date
- 25 Feb 2025
- Primary completion date
- Jan 2029
- Lead sponsor
- University Of Perugia
- NCT number
- NCT06845592
What you commit to
- Study type: Interventional
- Planned participants: 51
- From 25 Feb 2025 to the primary completion date, Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- AML patients
- AML in CR MRD-
- AML with \> 5% peripheral blasts or bone marrow infiltration ≥ 30%
- Age \< 18 years or \> 65 years
- ECOG \> 2
- Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
- Pregnancy
- No signature of the informed consent
- ALL patients
- ALL with \> 5% peripheral blasts or bone marrow infiltration ≥30%
- Philadelphia positive ALL
- Age \< 18 years or \> 65 years
- ECOG \> 2
- Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
- Pregnancy
- No signature of the informed consent
Who the study is looking for
- AML patients
- Diagnosis of AML with indication to allogeneic hematopoietic cell transplantation.
- Diagnosis of adverse genetic risk leukemia or presence of MRD or active disease (bone marrow infiltration 5-30%) at the time of the transplant procedure.
- Availability of a hematopoietic stem cell donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.
- Age ≥ 18 and ≤ 65 years
- ECOG ≤ 2
- HCT-CI ≤ 4 (51,52)
- Absence of relevant psychiatric diseases
- Signature of the informed consent
- ALL patients
- Diagnosis of ALL, either T or B (Philadelphia negative) or mixed phenotype with indication to allogeneic transplant
- Presence of MRD or active disease (bone marrow infiltration 5-30%) or patient with ≥ 2nd complete hematologic remission at the time of the transplant procedure.
- Availability of a hematopoietic stem cell family donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.
- Age ≥ 18 and ≤ 65 years
- ECOG ≤ 2
- HCT-CI ≤ 4
- Absence of relevant psychiatric diseases
- Signature of the informed consent
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Università degli Studi di Perugia Coordinator of this site? Confirm its status | Perugia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.