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)
Single group
HSCT with Treg/Tcon adoptive immunotherapy
Biological/VaccinePurified CD34+ hematopoietic progenitor cells with Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation from HLA-matched related donor
Number of participants free from disease 2 years after HSCT
The primary objective of the study is to reduce the incidence of disease relapse after myeloablative conditioning regimen and Treg/Tcon adoptive immunotherapy-based allogeneic transplantation from HLA-matched donors in high-risk AML patients.
Number of participants that have reached engraftment 45 days after HSCT
The study will also evaluate the impact of allo-HSCT from HLA-matched donors with myeloablative conditioning regimen and Treg/Tcon adoptive immunotherapy on full donor type engraftment
Number of participants that developed grade ≥ 2 acute GvHD
The study will also evaluate the impact of allo-HSCT from HLA-matched donors with myeloablative conditioning regimen and Treg/Tcon adoptive immunotherapy on grade ≥ 2 acute GvHD
Number of participants free from chronic GvHD 2 years after HSCT
The study will also evaluate the impact of allo-HSCT from HLA-matched donors with myeloablative conditioning regimen and Treg/Tcon adoptive immunotherapy on chronic GvHD
Number of participants who died for transplant related mortality after HSCT
The study will also evaluate the impact of allo-HSCT from HLA-matched donors with myeloablative conditioning regimen and Treg/Tcon adoptive immunotherapy on non relapse mortality (NRM)
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Antonio Pierini
Lead sponsor
University Of Perugia
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
