Blood transfusion dependent non-severe aplastic anemia
Conditions
Interventions
high-dose group:high-dose
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All enrolled patients were diagnosed as aplastic anemia through bone marrow smears and biopsy, and other disorders that could cause anemia were excluded. The peripheral blood cell count met the TD-NSAA diagnostic criteria, according with one of the three items: the absolute value of neutrophil count (ANC) < 0.5 x 10^9/L, absolute value of reticulocyte (Ret) < 20 x 10^9/L, platelet (PLT) Count < 20 x 10^9/L, meeting the TD-NSAA diagnostic criteria; 2. Aged < 60 years; 3. Red blood cell transfusion dependence and (or) platelet transfusion dependence; 4. Patients had not received ATG treatment; 5. Patients with a ECOG <= 2 points; 6. Patients with ALT of < 2.0 times higher than the normal upper limit, AST of < 2.0 ULN, total bilirubin of < 2.0 ULN, and serum creatinine and urea of < 1.25 ULN; And no evidence of cardiac insufficiency; 7. Female subjects had effective contraception (oral contraceptive, injectable contraceptive, intrauterine device, contraceptive patch, male sterilization) prior to enrollment and during the trial, and were negative for serum or urine pregnancy test at screening; 8. Subjects complying with the study protocol; 9. Subjects that signed the informed consent, which indicated they understood the purpose, the procedure and potential benefits of the trial and were willing to participate in the trial.
Exclusion criteria
Exclusion criteria: 1. Innate bone marrow debilitating disease, bone marrow proliferative tumor, paroxysmal nocturnal hemoglobinuria and other diseases; 2. Transfusion dependence; 3. Patients with clonal hematopoiesis, such as myelodysplastic syndromes, acute myeloid leukemia, etc.; 4. Use of other investigational drugs within 30 days prior to initial; 5. Patients with severe organ damage: respiratory failure, uncontrolled heart disease or congestive heart failure, decompensated liver insufficiency, renal insufficiency, etc.; 6. Men or women developed autoimmune hemolytic anemia or immune thrombocytopenia; 7. Patients that were sero-positive for HIV; 8.Patients with mental or other disorders that cannot completely cooperate with the treatment or follow up; 9. Patients bone marrow cannot be sampled; 10. Subjects that were allergic to immunosuppressive agents such as cyclosporin, glucocorticoids or severe allergy to biological products (including antibiotics); 11. Pregnant or lactating women; 12. Patients with other severe acute or chronic physical or mental disorders, or abnormal laboratory tests that may affect the formulation of the study protocol, the investigator's judgment of the condition and the interpretation of the study results, are not eligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Basic cure rate;Remission rate;Apparent improvement rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The quality of life;Hepatotoxicity;Renal toxicity;Hypertension;Gingival hyperplasia;Cytogenetic response;Molecular biologic response;subsets of lymphocytes; | — |
Countries
China
Contacts
Public ContactGuangsheng He
The First Affiliated Hospital of Nanjing Medical University Jiangsu Province Hospital
Outcome results
None listed