Immune Thrombocytopenia
Conditions
Keywords
Immune Thrombocytopenia, Rituximab, methylprednisolone
Brief summary
a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China
Detailed description
This is a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China. The investigators explore the efficacy and safety of Rituximab plus short-term methylprednisolone compare standard dose methylprednisolone in newly diagnosed ITP participants.
Interventions
DRUGRituximab plus methylprednisolone
rituximab （1000mg IV day1, week 3, week 17 , and week 19）
DRUGmethylprednisolone
1mg/kg, oral or IV; begin to reduce at week 4, reduce 8mg every 2 weeks, then another 8 weeks later reduce 2-4mg every 2-4 weeks
Sponsors
Beijing Hospital
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed 2. Platelet count less than 30×109/L on two occasions or Platelets above 30×109/L combined with bleeding manifestation 3. Subject is ≥ 18 years and ≤80years 4. Subject has signed and dated written informed consent. 5. Fertile patients must use effective contraception during treatment and observational period 6. Negative pregnancy test
Exclusion criteria
1. Have an impaired renal function as indicated by a serum creatinine level \> 2.0 mg/dL 2. Have an inadequate liver function as indicated by a total bilirubin level \> 2.0 mg/dL and/or an aspartate aminotransaminase or alanine aminotransferase level \> 3×upper limit of normal 3. Have a New York Heart Classification III or IV heart disease 4. Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures 5. Have active hepatitis B or hepatitis C infection 6. Have a HIV infection 7. Have active infection requiring antibiotic therapy within 7 days prior to study entry 8. Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug 9. Previous treatment with rituximab 10. Previous splenectomy 11. Had previous or concomitant malignant disease 12. Not willing to participate in the study. 13. Expected survival of \< 2 years 14. Intolerant to murine antibodies 15. Immunosuppressive treatment within the last month 16. Connective tissue disease 17. Autoimmune hemolytic anemia 18. Patients currently involved in another clinical trial with evaluation of drug treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse free survival | From date of randomization until the date of relapse or death from any cause, whichever came first, assessed up to 1 year | Relapse was defined as a drop in platelet count to \<30 ×109/L following an initial best response (partial or complete response). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative response rate | 1 year | platelet count ≥ 30 x 10\^9/L and at least 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding. |
| Cumulative complete response rate | 1 year | platelet count \>100 x 10\^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding |
| Cumulative relapse rate | 1 year | Time to response (from randomization to the achievement of response)Duration of response (from the initial response to the first relapse) |
| adverse event/serious adverse event and cumulative rate of bleeding events | 1 year | adverse event/serious adverse event associated with study drugs and bleeding events |
Contacts
Primary ContactXiao-Hui Zhang, Doctor
Backup ContactRu Feng, Doctor
Outcome results
None listed