Haploidentical Stem Cell Transplantation, Hematological Malignancies
Conditions
Keywords
haploidentical stem cell transplantation, hematological malignancies, ABO incompatibility
Brief summary
the impact of donor-recipient ABO matching on outcome of peripheral blood stem cell haploidentical hematopoietic stem cell transplantation
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.
Interventions
OTHERno intervention
no intervention, just observation
Sponsors
Affiliated Jinhua Hospital of Zhejiang University
First Affiliated Hospital of Zhejiang University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year Overall Survival | 5 year | 5-year Overall Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 5-year Non-relapse mortality | 5 year | 5-year non-relapse mortality |
| 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 |
| 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 |
Countries
China
Outcome results
None listed