Haploidentical Peripheral Blood Stem Cell Transplantation for Acute Leukemia

Peking University

Status: Enrolling

Conditions: Acute Leukemia

Treatments: Other: haplotype PBSCT

Study type: Observational

Funder types: Other

Identifiers

NCT03756675

Haplo-PBSCT for AL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 2 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 1 patient group

haplotype PBSCT group

Description:

Subjects in this group will receive haplotype peripheral blood stem cell transplantation (PBSCT) of "GIAC" system in the treatment of acute leukemia.

Treatment:

Other: haplotype PBSCT