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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05103995
Other study ID # ZJU-haplo-abo
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2013
Est. completion date October 1, 2021

Study information

Verified date October 2021
Source First Affiliated Hospital of Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

the impact of donor-recipient ABO matching on outcome of peripheral blood stem cell haploidentical hematopoietic stem cell transplantation


Description:

The impact of donor-recipient ABO compatibility on transplant outcomes had been evaluated in different transplant settings, but had shown different results. The investigators set out to investigate the impact of ABO incompatibility on post-transplant outcomes, engraftment kinetics and blood product requirements, transfusion independence, the incidence of poor graft function (PGF) in anti-T-lymphocyte globulin (ATG) based haplo-SCT with PBSC grafts.


Recruitment information / eligibility

Status Completed
Enrollment 510
Est. completion date October 1, 2021
Est. primary completion date March 31, 2019
Accepts healthy volunteers No
Gender All
Age group 15 Years to 70 Years
Eligibility Inclusion Criteria: 1. The subjects or their legal representatives signed the informed consent before the clinical study. 2. Subjects aged 15-70 years. 3. Patients with malignant hematological diseases plan to receive allogeneic peripheral blood stem cell transplantation 4. Patients have no suitable HLA identical sibling donor 5.Patients with malignant hematological diseases plan to receive HLA haploidentical stem cell transplantation 6. Subjects with ECoG score of 0-2. Exclusion Criteria: 1.Patients have suitable HLA identical sibling donor 2. Patients with severe liver and kidney function (alanine aminotransferase > 2.5 times of the upper normal limit, serum creatinine > 1.5 times of the upper normal limit), cardiopulmonary dysfunction (cardiac function NYHA III / IV, cardiac ejection fraction < 50%, severe obstructive or restrictive ventilation dysfunction); 3. Patients with active infection; 4. patients diagnosed with aplastic anemia before transplantation or died within 2 months after transplantation; 5. Subjects with ECoG score > 2; 6. Patients with secondary tumor; 7. Patients who cannot independently choose to enter or exit clinical trials due to serious central nervous system disease or mental disease.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
no intervention, just observation

Locations

Country Name City State
China The first Affiliated Hospital of Zhejiang University Hangzhou Zhejiang
China Affiliated Jinhua hospital of Zhejiang University Jinhua Zhejiang

Sponsors (2)

Lead Sponsor Collaborator
First Affiliated Hospital of Zhejiang University Affiliated Jinhua Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 5-year Overall Survival 5-year Overall Survival 5 year
Secondary 5-year Non-relapse mortality 5-year non-relapse mortality 5 year
Secondary 5-year cumulative incidence of chronic graft versus host disease 5-year cumulative incidence of chronic graft versus host disease 5 year
Secondary 28-day cumulative incidence of neutrophils engraftment numbers of participants achieved neutrophils engraftment at 28 days post transplantation 28 day
Secondary 28-day cumulative incidence of platelets engraftment numbers of participants achieved platelets engraftment at 28 days post transplantation 28 day
Secondary 365-day blood transfusion requirements numbers of blood products transfusion within 365-day after transplantation 365 day
Secondary cumulative incidence of blood transfusion independence within 60 days after transplantation numbers of participants achieved blood transfusion independence within 60 days after transplantation 60 day
Secondary the 5-year cumulative incidence of poor graft function the incidence of poor graft function numbers of participants occurred poor graft function 5 years post transplantation 5 year
Secondary the 5-year cumulative incidence of graft failure numbers of participants occurred graft failure 5 years post transplantation 5-year
Secondary 100-day cumulative incidence of acute graft versus host disease 100-day cumulative incidence of acute graft versus host disease 100-day
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