Haploidentical Peripheral Blood Stem Cell Transplantation for Acute Leukemia
- Conditions
- Acute Leukemia
- Interventions
- Other: haplotype PBSCT
- Registration Number
- NCT03756675
- Lead Sponsor
- Peking University People's Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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.
- with poor compliance;
- with uncontrolled current infections；
- pregnancy;
- donors with contraindications of mobilization and collection of peripheral blood stem cells;
- with mental sickness
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description haplotype PBSCT group haplotype PBSCT Subjects in this group will receive haplotype peripheral blood stem cell transplantation (PBSCT) of "GIAC" system in the treatment of acute leukemia.
- Primary Outcome Measures
Name Time Method engraftment rate 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 Outcome Measures
Name Time Method cumulative incidence of acute graft-versus-host disease(GVHD) one year after transplantation cumulative incidence of acute graft-versus-host disease(GVHD)
cumulative incidence of chronic GVHD at one year one year after transplantation cumulative incidence of chronic GVHD at one year
cumulative incidence of relapse at one year one year after transplantation 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.
cumulative incidence of non-relapse mortality (NRM) at one year one year after transplantation NRM was defined as the death without disease progression or relapse.
overall survival at one year one year after transplantation OS was defined as the time from the date of first dose until death due to any cause.
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, Beijing, China