Hematological Malignancies Clinical Trial
Official title:
Impact of Donor-recipient ABO Matching on Patients' Outcome After Peripheral Blood Stem Cell Haploidentical Stem Cell Transplantation
Verified date | October 2021 |
Source | First Affiliated Hospital of Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
the impact of donor-recipient ABO matching on outcome of peripheral blood stem cell haploidentical hematopoietic stem cell transplantation
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. |
Country | Name | City | State |
---|---|---|---|
China | The first Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang |
China | Affiliated Jinhua hospital of Zhejiang University | Jinhua | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Zhejiang University | Affiliated Jinhua Hospital of Zhejiang University |
China,
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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