aplastic anemia
Conditions
Interventions
Group 1:r-ATG 3.5mg/kg/d x 5d
Group 2:p-ATG 30mg/kg/d x 5d
Sponsors
The Second Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. All selected cases were diagnosed as aplastic anemia by bone marrow smear and bone marrow biopsy, and MDS and PNH were excluded. Peripheral blood cell count conforms to absolute neutrophil count (absoluteneutralphilcount, ANC) < 0.5 x 10^9/L, absolute value of reticulocyte (Ret) < 20 x 10^9/L, platelet < 20 x 10^9/L, one of the three items, meeting the diagnostic criteria of severe aplastic anemia SAA; 2. Age < 70 years old; 3. Red blood cell transfusion dependence and (or) platelet transfusion dependence; 4. Have not received ATG treatment; 5. ECOG physical status score <= 2 points; 6. The function of each organ is normal and meets the following inspection standards: liver function ALT, AST, TBIL <= 2 times the upper limit of normal value; renal function BUN, Cr <= 1.25 times the upper limit of normal value; 7. Electrocardiogram and echocardiography are normal, without cardiac insufficiency; 8. Female subjects have used effective means of contraception throughout the test (for example: oral contraceptives, injection contraceptives, intrauterine devices, contraceptive patches, male partner sterilization); negative serum or urine pregnancy tests at the time of screening; 9. Willing to abide by the prohibitions and restrictions of this trial protocol; 10. The subjects must sign the informed consent form, stating that they understand the purpose, steps and content of the trial and voluntarily participate in the trial.
Exclusion criteria
Exclusion criteria: 1. Congenital bone marrow failure diseases, myeloproliferative neoplasms, paroxysmal nocturnal hemoglobinuria and other diseases; 2. Not dependent on blood transfusion; 3. Clonal hematopoiesis: such as MDS, AML, PNH; 4. Have used other investigational drugs within 30 days before the first use of this test drug; 5. There are other serious diseases, such as serious damage to important organ functions: respiratory failure, heart failure, decompensated liver insufficiency, renal insufficiency, etc.; 6. Complicated with autoimmune hemolytic anemia or immune thrombocytopenia; 7. It is known that HIV seropositive patients have mental illness or other diseases, and cannot fully cooperate with the experimental treatment or follow-up requirements; 8. The bone marrow cannot be extracted; 9. Known to be allergic to ATG or have a history of severe allergy to biological products (including antibiotics); 10. Pregnant or lactating women; 11. Suffering from other severe acute or chronic physical or mental diseases, or abnormal laboratory tests, which may affect the administration of study drugs and the investigator's judgment on the condition and interpretation of test results, such patients are not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lymphocyte subsets; | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics;neutralizing antibodies against ATG in plasma;neutrophil count;side effects of serum disease;Infection-related mortality;Treatment-related mortality;2-year event-free survival;2-year overall survival rate; | — |
Countries
China
Contacts
Public ContactYu Sun
The Second Affiliated Hospital of Soochow University
Outcome results
None listed