Initial diagnosis of non-severe aplastic anemia
Conditions
Interventions
Control group: Cyclosporine A and Stanozolol:CsA at a dose of 3 to 5mg/(kg·d) should be taken orally in two divided doses. Blood drug concentration should be monitored two weeks later, and then once a
Intervention group: arsenic trioxide for injection combined with cyclosporine A and stanzolol:ATO 0.15mg/(kg·d), added to 5% glucose injection or normal saline for continuous intravenous infusion in t
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patient aged 18 or older and 65 or younger, male or female. 2.Understand the research procedures and sign the informed consent form in person. 3.Based on the "Chinese Guidelines for Diagnosis and Treatment of Aplastic Anemia (2022 Edition)", it was diagnosed as NSAA. 4.ECOG score: 0 - 2 points; 5.Liver and kidney functions are normal;
Exclusion criteria
Exclusion criteria: 1.Patients with uncontrolled bleeding and/or infection who failed to respond to standard treatment before being included in the study; 2.During the screening period, those with HIV infection or positive hepatitis C antibody (if the hepatitis B surface antigen is positive, or if the hepatitis B surface antigen is negative but the hepatitis B core antibody is positive, HBV-DNA testing is required. If it indicates viral replication, the subjects should be excluded); 3.Having a history of liver cirrhosis or portal hypertension; 4.Screen for any solid tumors in any organ system that occurred in the subjects within the past 5 years; 5.Within one year prior to enrollment, there was a history of congestive heart failure requiring medication treatment, peripheral arteriovenous thrombosis, or myocardial infarction or cerebral infarction occurred within the previous three months. 6.Women who are pregnant or are breastfeeding, or those planning to conceive within the next 6 months; 7. The patient or his/her spouse is unable to take effective contraceptive measures; 8. Participated in other clinical trials within 3 months prior to enrollment; 9. The researcher believes that there are any other circumstances that may prevent the subject from completing this study or pose obvious risks to the subject;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of remission (DOR);Time to remission (TTR);Progression-free survival (PFS);Overall survival (OS);Safety; | — |
Countries
China
Contacts
Public ContactFang Baijun
Henan Cancer Hospital
Outcome results
None listed