- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03756675
Haploidentical Peripheral Blood Stem Cell Transplantation for Acute Leukemia
September 15, 2020 updated by: Xiaojun Huang,MD, Peking University People's Hospital
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.
Study Overview
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-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.
Study Type
Observational
Enrollment (Anticipated)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yu Wang, MD
- Phone Number: 13552647384
- Email: ywyw3172@sina.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100044
- Recruiting
- Peking University People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
haplotype peripheral blood stem cell transplantation (PBSCT) of "GIAC" system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
engraftment rate
Time Frame: one year after transplantation
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cumulative incidence of acute graft-versus-host disease(GVHD)
Time Frame: one year after transplantation
|
cumulative incidence of acute graft-versus-host disease(GVHD)
|
one year after transplantation
|
cumulative incidence of chronic GVHD at one year
Time Frame: one year after transplantation
|
cumulative incidence of chronic GVHD at one year
|
one year after transplantation
|
cumulative incidence of relapse at one year
Time Frame: one year after transplantation
|
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
Time Frame: one year after transplantation
|
NRM was defined as the death without disease progression or relapse.
|
one year after transplantation
|
overall survival at one year
Time Frame: one year after transplantation
|
OS was defined as the time from the date of first dose until death due to any cause.
|
one year after transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiao-Jun Huang, MD, Peking University People's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2018
Primary Completion (Anticipated)
November 1, 2023
Study Completion (Anticipated)
November 1, 2025
Study Registration Dates
First Submitted
November 27, 2018
First Submitted That Met QC Criteria
November 27, 2018
First Posted (Actual)
November 28, 2018
Study Record Updates
Last Update Posted (Actual)
September 17, 2020
Last Update Submitted That Met QC Criteria
September 15, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Haplo-PBSCT for AL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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