Transfusion dependent non severe aplastic anemia
Conditions
Interventions
Experimental group:(rATG/Bu/CTX/Flu/FK506) protocol: Rabbit anti thymocyte globulin 2.5 mg/(kg·d) (-13 days to -10 days), busulfan 3.2 mg/(kg·d) (-7 days to -6 days), cyclophosphamide 25 mg/(kg·d) (-5
Sponsors
The First Affiliated Hospital of Henan University of Science and Technology
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: •TD-NSAA patients confirmed by bone marrow morphology and immunology •Age 12 and above • Liver function: blood bilirubin = 35 µ Mol/L, AST/ALT below 2 times the upper limit of normal value •According to the CKD staging of chronic kidney disease in the United States, renal function: 15 mL/min<glomerular filtration rate GFR<90 mL/min •Physical condition score 0-2 (ECOG score, see Attachment 2 for details) •Obtain informed consent signed by the patient or family member
Exclusion criteria
Exclusion criteria: 1. Have a known history of immediate or delayed hypersensitivity reactions to similar drugs and excipients of the study drug; 2. High titer positive donor specific antibody DSA; 3. Significant abnormalities in liver function exceeding the entry and exit criteria; 4. Heart function and disease meet one of the following conditions: a)Long QTc syndrome or QTc interval>480 ms; b) completeness left bundle branch block, grade II or III atrioventricular block; c)Severe and uncontrolled arrhythmia requiring medication treatment; d) New York Heart Association rating = Level II; e) Cardiac ejection fraction (LVEF) below 50% or below the lower limit of the range of laboratory test values at the research center; f) A history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmia requiring treatment, clinical history of severe pericardial disease, or electrocardiogram evidence of acute ischemic or active conduction system abnormalities within 6 months prior to recruitment. 5. Previous or current concurrent presence of other malignancies (except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignancies that have not been treated and effectively controlled in the past five years); 6. According to the CKD staging of chronic kidney disease in the United States, renal function: glomerular filtration rate GFR = 15 mL/min 7. Patients under the age of 10 or over 45 years old 8. Active infection and bleeding 9. Previous or current concurrent presence of other malignancies (except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignancies that have not been treated and effectively controlled in the past five years); 10. Uncontrolled systemic diseases; (such as progressive infection, uncontrollable hypertension, diabetes, etc.); 11. People infected with Human Immunodeficiency Virus (HIV) (HIV antibody positive); 12. Active infection of hepatitis B and hepatitis C (hepatitis B virus surface antigen is positive; hepatitis B core antibody is positive and hepatitis B virus DNA exceeds 1x103 copies/mL; hepatitis C virus RNA exceeds 1x103 copies/mL); 13.Pregnant women, lactating women, and patients who refuse to take effective contraceptive measures during the study period; 14. Accompanied by a history of severe neurological or mental illness; 15.The researcher concluded that there are patients who are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematopoietic reconstruction time;Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infection rates;Incidence of acute graft versus host disease (aGVHD) of grade III-IV;The incidence of chronic graft versus host disease (cGVHD);Prevalence of Extensiveness (cGVHD); | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS;OS; | — |
Countries
China
Contacts
Public ContactHaiping Yang
The First Affiliated Hospital of Henan University of Science and Technology
Outcome results
None listed