a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
rituximab (1000mg IV day1, week 3, week 17 , and week 19)
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
Relapse free survival
Relapse was defined as a drop in platelet count to \<30 ×109/L following an initial best response (partial or complete response).
Time frame: From date of randomization until the date of relapse or death from any cause, whichever came first, assessed up to 1 year
Cumulative response rate
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.
Time frame: 1 year
Cumulative complete response rate
platelet count \>100 x 10\^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding
Time frame: 1 year
Cumulative relapse rate
Time to response (from randomization to the achievement of response)Duration of response (from the initial response to the first relapse)
Time frame: 1 year
adverse event/serious adverse event and cumulative rate of bleeding events
adverse event/serious adverse event associated with study drugs and bleeding events
Time frame: 1 year
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