Impact of Donor-recipient ABO Matching on Haploidentical Stem Cell Transplantation
Study Details
Study Description
Brief Summary
the impact of donor-recipient ABO matching on outcome of peripheral blood stem cell haploidentical hematopoietic stem cell transplantation
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
ABO matched Donor-recipient ABO matched |
Other: no intervention
no intervention, just observation
|
Minor incompatibility Donor-recipient minor incompatibility |
Other: no intervention
no intervention, just observation
|
Major incompatibility Donor-recipient major incompatibility |
Other: no intervention
no intervention, just observation
|
Bidirectional incompatibility Donor-recipient bidirectional incompatibility |
Other: no intervention
no intervention, just observation
|
Outcome Measures
Primary Outcome Measures
- 5-year Overall Survival [5 year]
5-year Overall Survival
Secondary Outcome Measures
- 5-year Non-relapse mortality [5 year]
5-year non-relapse mortality
- 5-year cumulative incidence of chronic graft versus host disease [5 year]
5-year cumulative incidence of chronic graft versus host disease
- 28-day cumulative incidence of neutrophils engraftment [28 day]
numbers of participants achieved neutrophils engraftment at 28 days post transplantation
- 28-day cumulative incidence of platelets engraftment [28 day]
numbers of participants achieved platelets engraftment at 28 days post transplantation
- 365-day blood transfusion requirements [365 day]
numbers of blood products transfusion within 365-day after transplantation
- cumulative incidence of blood transfusion independence within 60 days after transplantation [60 day]
numbers of participants achieved blood transfusion independence within 60 days after transplantation
- the 5-year cumulative incidence of poor graft function the incidence of poor graft function [5 year]
numbers of participants occurred poor graft function 5 years post transplantation
- the 5-year cumulative incidence of graft failure [5-year]
numbers of participants occurred graft failure 5 years post transplantation
- 100-day cumulative incidence of acute graft versus host disease [100-day]
100-day cumulative incidence of acute graft versus host disease
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The first Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | China | 310000 |
2 | Affiliated Jinhua hospital of Zhejiang University | Jinhua | Zhejiang | China |
Sponsors and Collaborators
- First Affiliated Hospital of Zhejiang University
- Affiliated Jinhua Hospital of Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZJU-haplo-abo