Matched Sibling Allogenic Stem Cell Transplantation With Adoptive Immunotherapy With Regulatory And Conventional T Cells For High Risk Acute Myeloid Leukemia

MATCH-Treg: Matched Sibling Allogenic Stem Cell Transplantation With Adoptive Immunotherapy With Regulatory And Conventional T Cells For High Risk Acute Myeloid Leukemia

The study is a multicentric, interventional study that evaluates the efficacy of allogeneic HLA-matched allo-HSCT consisting of myeloablative conditioning coupled with donor Treg/Tcon adoptive immunotherapy for high-risk AML patients.

Inclusion Criteria:

• Diagnosis of AML with adverse genetic mutations in Complete Remission (CR) or incomplete (i) CR according to ELN 2022 recommendations with or without MRD positivity at the time of the HSCT procedure;
• Diagnosis of AML with intermediate genetic mutations in Complete remission (CR) or incomplete (i) CR according to ELN 2022 with MRD positivity at the time of the transplant;
• Fitness to undergo allo-HCT with myeloablative conditioning regimens according to center policy;
• Availability of a family HLA-matched hematopoietic stem cell donor 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 ≤ 70 years
• ECOG ≤ 2
• HCT-CI ≤ 4
• Signature of the informed consent

Exclusion Criteria:

• Prior allo-HSCT
• AML with favorable genetic abnormalities
• AML with intermediate genetic risk with MRD negativity
• Active disease at transplant (> 5% bone marrow infiltration)
• Availability of a haploidentical or matched unrelated donor (MUD)
• Age < 18 years or > 70 years
• ECOG > 2
• Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
• Uncontrolled bacterial, viral, or fungal infections at time of enrollment
• Pregnancy
• No signature of the informed consent