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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| haplotype PBSCT group | Subjects in this group will receive haplotype peripheral blood stem cell transplantation (PBSCT) of "GIAC" system in the treatment of acute leukemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| haplotype PBSCT | Other | haplotype peripheral blood stem cell transplantation (PBSCT) of "GIAC" system |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged 2-60, who plan to receive haplotype PBSCT in the first complete remission phase (CR1) of acute leukemia, and with no uncontrolled current infections or organ failure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Wang, MD | Contact | 13552647384 | ywyw3172@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao-Jun Huang, MD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35505384 | Derived | Shen MZ, Hong SD, Lou R, Chen RZ, Zhang XH, Xu LP, Wang Y, Yan CH, Chen H, Chen YH, Han W, Wang FR, Wang JZ, Liu KY, Huang XJ, Mo XD. A comprehensive model to predict severe acute graft-versus-host disease in acute leukemia patients after haploidentical hematopoietic stem cell transplantation. Exp Hematol Oncol. 2022 May 3;11(1):25. doi: 10.1186/s40164-022-00278-x. | |
| 35392613 |
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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 |
| Shen MZ, Hong SD, Wang J, Zhang XH, Xu LP, Wang Y, Yan CH, Chen H, Chen YH, Han W, Wang FR, Wang JZ, Liu KY, Huang XJ, Mo XD. A Predicted Model for Refractory/Recurrent Cytomegalovirus Infection in Acute Leukemia Patients After Haploidentical Hematopoietic Stem Cell Transplantation. Front Cell Infect Microbiol. 2022 Mar 22;12:862526. doi: 10.3389/fcimb.2022.862526. eCollection 2022. |
| 33791217 | Derived | Ma YR, Zhang X, Xu L, Wang Y, Yan C, Chen H, Chen Y, Han W, Wang F, Wang J, Liu K, Huang X, Mo X. G-CSF-Primed Peripheral Blood Stem Cell Haploidentical Transplantation Could Achieve Satisfactory Clinical Outcomes for Acute Leukemia Patients in the First Complete Remission: A Registered Study. Front Oncol. 2021 Mar 15;11:631625. doi: 10.3389/fonc.2021.631625. eCollection 2021. |