Randomized, open-label, multicenter study to compare the efficacy and safety of ATRA plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).
The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 132 adults with ITP in China. Patients were randomized to ATRA+ high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Dexamethasone, iv, 40 mg/d, for 4 days (The 4-day course of dexamethasone was repeated in the case of lack of response by day 10)
ATRA, po,10mg bid, for 12 weeks
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China
Sustained response
The maintenance of platelet count ≥ 30 x 10\^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up.
Time frame: 6 month
complete response (CR)
complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.
Time frame: day 14
Response (R)
Response (R) as platelet count more than 30,000 per cubic millimeter and at least 2-fold increase of the baseline count and absence of bleeding.
Time frame: day 14
Number of patients with bleeding
Number of patients with bleeding complication ( WHO bleeding score).
Time frame: 6 month
Number of patients with adverse events
Number of patients with adverse events.
Time frame: 6 month
Time to response
The time from starting treatment to time of achievement of CR or R
Time frame: 6 month
Duration of response (DOR)
Duration of response at 6-month follow up.
Time frame: 6 month
Loss of response
Platelet counts below 100 x 109/L or bleeding (from CR) or platelet counts below 30 x 109/L, less than 2-fold increase of baseline platelet count or bleeding (from R)
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Time frame: 6 month