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.
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.
Prior allo-HSCT
AML with favorable genetic abnormalities
AML with intermediate genetic risk with MRD negativity
Active disease at transplant (> 5% bone marrow infiltration)
Antonio Pierini
Lead sponsor
University Of Perugia
Sponsor institution