Ignite Creation Date:
2024-05-06 @ 12:24 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03756675
Status:
RECRUITING
Last Update Posted:
2020-09-17
First Post:
2018-11-27
Brief Title:
Haploidentical Peripheral Blood Stem Cell Transplantation for Acute Leukemia
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
Haploidentical Peripheral Blood Stem Cell Transplantation for Acute Leukemia
Status:
RECRUITING
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-mismatchedhaploidentical 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-mismatchedhaploidentical 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None