Idiopathic Thrombocytopenic Purpura
Conditions
Interventions
Standard dose group:Rituximab (Hanrikang) 375mg/m2, 4 times a week (day 8, 15, 22, 29).
Low-dose group:Rituximab (Hanrikang) 100mg/ time once a week, administered 4 times (day 8, 15, 22 and 29).
Dexamethasone control group:high-dose dexamethasone (HD-DXM), 40mg/d, iv for 4 days (day 1 to day 4), every 15 days, 2 to 4 cycles, until CR or the end of the study.
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 65 years of age, men and women are not limited; 2. Patients with definite diagnosis of immune thrombocytopenia within 2 or 3 months and without normal hormone therapy; 3. Platelet count <= 30*10^9/L or platelet count < 50*10^9 /L with bleeding symptoms; 4. Those who can understand the procedures and methods of this study, are willing to sign the informed consent and strictly comply with the clinical trial protocol; 5. Subjects agree to use effective contraceptive methods during the study period and for 6 months after the end of the last medication.
Exclusion criteria
Exclusion criteria: 1. HCV antibody, HBs antigen, HBc antibody and HIV antibody are positive; 2. Live vaccine was inoculated within 4 weeks before screening; 3. Active tuberculosis; 4. Renal function decreased, serum creatinine > 1.5 times the normal upper limit 5. Abnormal liver function, upper limit of AST or ALT > 2.5 times normal; 6. Existing angina pectoris, heart failure, myocardial infarction, severe arrhythmia or related medical history; 7. Have cancer or a history of cancer; 8. Has a serious mental illness; 9. Have received any monoclonal antibody treatment; 10. Received any study drugs or participated in other clinical studies within 6 months before enrollment; 11. Pregnant and lactating women; 12. Situations where other researchers consider it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total response rate (ORR) at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Response at 1, 2 and 3 years;Complete response at 1, 2 and 3 years;Recurrence rate in 1, 2 and 3 years;Time to relapse;Incidence of adverse events;Quality of life status assessment; | — |
Countries
China
Contacts
Public ContactZhou Hu
Henan Cancer Hospital
Outcome results
None listed