Haploidentical Peripheral Blood Stem Cell Transplantation for Acute Leukemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Haploidentical Peripheral Blood Stem Cell Transplantation for Acute Leukemia

Conditions
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Acute Leukemia

Intervention / Treatment
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* Other: haplotype PBSCT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| haplotype PBSCT group<br>Subjects in this group will receive haplotype peripheral blood stem cell transplantation (PBSCT) of GIAC system in the treatment of acute leukemia. | Other: haplotype PBSCT<br>* haplotype peripheral blood stem cell transplantation (PBSCT) of GIAC system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| engraftment 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. | one year after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative incidence of acute graft-versus-host disease(GVHD) | cumulative incidence of acute graft-versus-host disease(GVHD) | one year after transplantation | 
| cumulative incidence of chronic GVHD at one year | cumulative incidence of chronic GVHD at one year | 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. | 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. | 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. | one year after transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allogeneic stem cell transplantation, G-CSF-mobilized peripheral blood stem cell, haplotype