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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Purified CD34+ hematopoietic progenitor cells with Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation from HLA-matched related donor
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia
Perugia, Italy
Presidio Ospedaliero Pescara - Azienda Sanitaria Locale di Pescara
Pescara, Italy
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.
Time frame: 2 years
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
Time frame: 45 days
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
Time frame: 100 days
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
Time frame: 2 years
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)
Time frame: 2 years
Number of patients free from ≥ 2 acute GvHD and/or moderate/severe chronic GvHD and/or relapse
The study will also measure grade ≥ 2 acute GvHD and/or moderate/severe chronic GvHD/Relapse-free survival (GRFS)
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Time frame: 2 years
Number of patients free from moderate/severe chronic GvHD and relapse
The study will also measure moderate/severe chronic GvHD-Relapse-free survival (CRFS)
Time frame: 2 years
Number of patients alive after 2 years after allogeneic transplant
Overall survival (OS) of patients treated with allogeneic transplant
Time frame: 2 years