Haploidentical Peripheral Blood Stem Cell Transplantation for Acute Leukemia

Acute Leukemia Clinical Trial

Official title:

Haploidentical Peripheral Blood Stem Cell Transplantation for Acute Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03756675
• Other study ID #: Haplo-PBSCT for AL
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: November 1, 2025

Study information

• Verified date: September 2020
• Source: Peking University People's Hospital
• Contact: Yu Wang, MD
• Phone: 13552647384
• Email: ywyw3172[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2023
• Gender: All
• Age group: 2 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia

Intervention

Other:
• haplotype PBSCT
haplotype peripheral blood stem cell transplantation (PBSCT) of "GIAC" system

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	cumulative incidence of acute graft-versus-host disease(GVHD)	cumulative incidence of acute graft-versus-host disease(GVHD)	one year after transplantation
Secondary	cumulative incidence of chronic GVHD at one year	cumulative incidence of chronic GVHD at one year	one year after transplantation
Secondary	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
Secondary	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
Secondary	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