Treatment of ITP With Rituximab and / or Accutane
- Conditions
- Immune Thrombocytopenia
- Interventions
- Registration Number
- NCT02757196
- Lead Sponsor
- Peking University People's Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 112
- Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed
- Platelet count less than 30×109/L on two occasions or Platelets above 30×109/L combined with bleeding manifestation
- Subject is ≥ 18 years and ≤80years
- Subject has signed and dated written informed consent.
- Fertile patients must use effective contraception during treatment and observational period
- Negative pregnancy test
- Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL
- 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
- Have a New York Heart Classification III or IV heart disease
- Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
- Have active hepatitis B or hepatitis C infection
- Have a HIV infection
- Have active infection requiring antibiotic therapy within 7 days prior to study entry
- Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug
- Previous treatment with rituximab
- Previous splenectomy
- Had previous or concomitant malignant disease
- Not willing to participate in the study.
- Expected survival of < 2 years
- Intolerant to murine antibodies
- Immunosuppressive treatment within the last month
- Connective tissue disease
- Autoimmune hemolytic anemia
- Patients currently involved in another clinical trial with evaluation of drug treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Rituximab plus methylprednisolone Rituximab plus methylprednisolone Combination therapy with rituximab （1000mg IV day1, week 3, week 17 , and week 19）plus short-term methylprednisolone (1mg/kg, oral or IV; reduce to 50% of base dose at week 4, then reduce 8mg every 1 week until stopped). Methylprednisolone methylprednisolone standard dose methylprednisolone alone (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).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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.
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