pure red cell aplasia
Conditions
Interventions
Slower dose-reduction group:Slower dose-reduction
Rapid dose-reduction group:Rapid dose-reduction
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
15 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) All enrolled patients were diagnosed with pure red cell aplasia by bone marrow smear and biopsy, and other disorders that could cause anemia were excluded; The peripheral blood cell count met the diagnostic criteria for PRCA; (2) Men or women aged 18 to 75 years; (3) Patients with a ECOG of 0 to 2; (4) Patients with a AST of < 2.0 times higher than the normal upper limit, ALT of < 2.0 times higher than the normal upper limit, total bilirubin of < 2.0times higher than the normal upper limit, and serum creatinine and urea of < 1.25 times higher than the normal upper limit; And no evidence of cardiac insufficiency; (5) 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; (6) Subjects complying with the study protocol; (7) 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) Patients suffered from congenital bone marrow failure disease, myeloproliferative neoplasms, paroxysmal nocturnal hemoglobinuria and other diseases; (2) Patients with clonal hematopoiesis, such as myelodysplastic syndromes, acute myeloid leukemia, paroxysmal nocturnal hemoglobinuria, etc.; (3) Patients with severe organ damage: respiratory failure, uncontrolled heart disease or congestive heart failure, decompensated liver insufficiency, renal insufficiency, etc.; (4) Men or women developed autoimmune hemolytic anemia or immune thrombocytopenia; (5) Patients that were sero-positive for HIV; (6) Patients with mental or other disorders that cannot completely cooperate with the treatment or follow up; (7) Patients bone marrow cannot be sampled; (8) Subjects that were allergic to immunosuppressive agents such as cyclosporin, glucocorticoids or severe allergy to biological products (including antibiotics); (9) Pregnant or lactating women; (10) 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 |
|---|---|
| recurrence rate;Time to recurrence; | — |
Secondary
| Measure | Time frame |
|---|---|
| re-induction rate;partial response rate;complete response rate;overall response rate; | — |
Countries
China
Contacts
Public ContactGuangsheng He
The First Affiliated Hospital of Nanjing Medical University Jiangsu Province Hospital
Outcome results
None listed