Haploidentical Peripheral Blood Stem Cell Transplantation for Acute Leukemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Leukemia
- Sponsor
- Peking University People's Hospital
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- engraftment rate
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Xiaojun Huang,MD
Supervisor of Hematology, Peking University People's Hospital
Peking University People's Hospital
Eligibility Criteria
Inclusion Criteria
- •2-60 years old, all genders;
- •the first complete remission phase (CR1) of acute leukemia;
- •planning to receive haplotype PBSCT;
- •no uncontrolled current infections (new infections, body temperature still above 38 ℃ after treatment with broad-spectrum antibiotics for 72h, except for other non-infectious factors);
- •no organ failure.
Exclusion Criteria
- •with poor compliance;
- •with uncontrolled current infections；
- •pregnancy;
- •donors with contraindications of mobilization and collection of peripheral blood stem cells;
- •with mental sickness
Outcomes
Primary Outcomes
engraftment rate
Time Frame: one year after transplantation
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.
Secondary Outcomes
- cumulative incidence of acute graft-versus-host disease(GVHD)(one year after transplantation)
- cumulative incidence of chronic GVHD at one year(one year after transplantation)
- cumulative incidence of relapse at one year(one year after transplantation)
- cumulative incidence of non-relapse mortality (NRM) at one year(one year after transplantation)
- overall survival at one year(one year after transplantation)