Haploidentical Peripheral Blood Stem Cell Transplantation for Acute Leukemia

NCT03756675 | Unknown

• 1 other identifier: Haplo-PBSCT for AL
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Acute Leukemia

Keywords

allogeneic stem cell transplantation; G-CSF-mobilized peripheral blood stem cell; haplotype

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• cumulative incidence of acute graft-versus-host disease(GVHD)

  one year after transplantation

• cumulative incidence of chronic GVHD at one year

  one year after transplantation

• cumulative incidence of relapse at one year

  one year after transplantation

• cumulative incidence of non-relapse mortality (NRM) at one year

  one year after transplantation

• overall survival at one year

  one year after transplantation

Study Arms (1)

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.

Other: haplotype PBSCT

Interventions

haplotype PBSCT OTHER

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

haplotype PBSCT group

Eligibility Criteria

• Age: 2 Years - 60 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• with poor compliance;
• with uncontrolled current infections；
• pregnancy;
• donors with contraindications of mobilization and collection of peripheral blood stem cells;
• with mental sickness

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 35505384 DERIVED

• 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.

  PMID: 35392613 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.

  PMID: 33791217 DERIVED

Study Officials

• Xiao-Jun Huang, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Wang, MD

CONTACT

13552647384; ywyw3172@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor of Hematology, Peking University People's Hospital

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 28, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2025
• Last Updated: September 17, 2020

Record last verified: 2020-09

Locations

CN (1)