Radiation and donor immune cells before stem cell transplant for high-risk acute leukemia
Tests radiation plus donor immune cells before transplant in adults with high-risk acute leukemia.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Perugia, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06845592, who can take part
Where in Italy
- Università degli Studi di PerugiaPerugia, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Of Perugia
- Trial code
- NCT06845592
- Record updated
- 4 March 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.