Haplotype hematopoietic stem cell transplantation for SAA
Conditions
Interventions
Haplotype allogeneic hematopoietic stem cell transplantation:Haplotype transplantation pretreatment protocol:
Busulfan (BU) 3.2 mg/kg/d (0.8 mg/kg, q6h) × 2D (-7 to - 6d) + cyclophosphamide (CY) 50 mg
Sponsors
Hongci Hematology Branch of the First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
1 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Cases: All the selected cases were diagnosed as severe aplastic anemia by bone marrow cell morphology, cytochemistry, immunophenotyping, chromosome and pathology. The diagnostic criteria were based on the Diagnostic Criteria for Hematological Diseases edited by Zhang Zhinan; 2. Haplotype hematopoietic stem cell transplantation; 3. Age < 50 years, KPS = 70; 4. Liver function ALT, AST and ALP = 2 times the upper limit of normal value, renal function BUN, Cr = 1.25 times the upper limit of normal value; 5. The following cardiac function conditions are met: electrocardiogram does not indicate any acute myocardial infarction, arrhythmia, or atrioventricular block above degree I; there is no cardiac insufficiency; there is no active rheumatic heart disease; chest X-ray or physical examination does not indicate cardiac enlargement; 6. The patient had no contraindication to hematopoietic stem cell transplantation; 7. The patient had no contraindication to the use of C5 monoclonal antibody; 8. Patients and their clients have the desire and request for hematopoietic stem cell transplantation; 9. A haplotype related donor that provides hematopoietic stem cells.
Exclusion criteria
Exclusion criteria: 1. At the same time, he suffers from other serious physical or mental diseases that may affect the expression of his condition and the validity of informed consent or lead to the survival of the patient within 2 years; 2. Chronic infections (including bacterial, fungal or viral infections) that are difficult to control, such as dental caries, otitis media, sinusitis, etc., should be carried out after effective control; 3. History of severe pulmonary dysfunction; 4. A history of diabetes mellitus with a tendency to ketoacidosis; 5. Severe coagulation disorders, thrombophlebitis, or pulmonary embolism; 6. Decompensated hepatic insufficiency and active hepatitis; 7. History of severe autoimmune disease; 8. Abnormal thyroid function in the past, and the current thyroid function can not be maintained within the normal range; 9. Other malignant tumors within 5 years before initial diagnosis; 10. History of severe allergy to biological products (including antibiotics); 11. Pregnant or lactating women; 12. Congenital bone marrow failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, location and degree of acute GVHD within 100 days after transplantation;Incidence of chronic GVHD at 1 and 2 years after transplantation;1-year and 2-year overall survival, failure-free survival, relapse rate, and non-relapse-related mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue changes;Hematopoietic reconstruction and implantation;Incidence of infection; | — |
Countries
China
Contacts
Public ContactLimin Liu
Hongci Hematology Branch of the First Affiliated Hospital of Soochow University
Outcome results
None listed