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

Inclusion criteria

• 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 criteria

• 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