Allogeneic stem cell transplantation (Allo-HSCT) is the effective and even the only treatment for hematological malignancies. The "GIAC" protocol established by our center has successfully crossed the HLA barrier in HLA-mismatched/haploidentical HSCT. The protocol entails the following: treating donors with granulocyte colony-stimulating factor (G-CSF) to induce donor immune tolerance, intensified immunologic suppression to both promote engraftment and to prevent GVHD, antithymocyte globulin (ATG) was included for the prophylaxis of GVHD and graft rejection, and combination of G-CSF-primed bone marrow harvest (G-BM) and G-CSF-mobilized peripheral blood stem cell harvest (G-PB) as the source of stem cell grafts. But peripheral blood transplantation is still prevalent. Compared with BM, G-PB is more convenient to collect, and the number of T lymphocytes and CD34+ cells is higher. It is reported that G-PB has a higher implantation rate and even a higher disease-free survival rate in sibiling-identical transplantation compared with BM transplantation, whereas there were also reports with different conclusions. This prospective, one-arm clinical cohort study aims to evaluate the safety and efficacy of haplotype peripheral blood stem cell transplantation (PBSCT) in the treatment of acute leukemia.
Allogeneic stem cell transplantation (Allo-HSCT) is the effective and even the only treatment for hematological malignancies. The "GIAC" protocol established by our center has successfully crossed the HLA barrier in HLA-mismatched/haploidentical HSCT. The protocol entails the following: treating donors with granulocyte colony-stimulating factor (G-CSF) to induce donor immune tolerance, intensified immunologic suppression to both promote engraftment and to prevent GVHD, antithymocyte globulin (ATG) was included for the prophylaxis of GVHD and graft rejection, and combination of G-CSF-primed bone marrow harvest (G-BM) and G-CSF-mobilized peripheral blood stem cell harvest (G-PB) as the source of stem cell grafts. But peripheral blood transplantation is still prevalent. Compared with BM, G-PB is more convenient to collect, and the number of T lymphocytes and CD34+ cells is higher. It is reported that G-PB has a higher implantation rate and even a higher disease-free survival rate in sibiling-identical transplantation compared with BM transplantation, whereas there were also reports with different conclusions. This prospective, one-arm clinical cohort study aims to evaluate the safety and efficacy of haplotype peripheral blood stem cell transplantation (PBSCT) in the treatment of acute leukemia.
Study Type
OBSERVATIONAL
Enrollment
45
haplotype peripheral blood stem cell transplantation (PBSCT) of "GIAC" system
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGengraftment rate
Neutrophil recovery was defined as an absolute neutrophil count(ANC) of 0.5×10\^9/L or more for three consecutive days and platelet recovery, as 20×10\^9/L or more for seven consecutive days without transfusion.
Time frame: one year after transplantation
cumulative incidence of acute graft-versus-host disease(GVHD)
cumulative incidence of acute graft-versus-host disease(GVHD)
Time frame: one year after transplantation
cumulative incidence of chronic GVHD at one year
cumulative incidence of chronic GVHD at one year
Time frame: one year after transplantation
cumulative incidence of relapse at one year
Cumulative incidence of relapse was defined as the cumulative incidences of presence of morphological evidence of disease in samples from peripheral blood, bone marrow, or extramedullary sites, or by the recurrence and sustained presence of pre-transplantation chromosomal abnormalities.
Time frame: one year after transplantation
cumulative incidence of non-relapse mortality (NRM) at one year
NRM was defined as the death without disease progression or relapse.
Time frame: one year after transplantation
overall survival at one year
OS was defined as the time from the date of first dose until death due to any cause.
Time frame: one year after transplantation
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