The goal of this clinical trial is to find the best dose of zanubrutinib when used together with high-dose dexamethasone for adults who are newly diagnosed with primary immune thrombocytopenia (ITP), and to learn how safe and effective this combination treatment is.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Zanubrutinib: 80 mg taken orally once daily for 26 weeks
Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.
Zanubrutinib: 160 mg taken orally once daily for 26 weeks
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 26-week follow-up.
Time frame: 26 weeks
Initial 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
Initial 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
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 26-week follow up
Time frame: 26 weeks
Bleeding events
Number of patients with bleeding
Time frame: 26 weeks
Adverse events
Number of patients with adverse events
Time frame: 26 weeks
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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Zanubrutinib: 240 mg taken orally once daily for 26 weeks
Time frame: 26 weeks
Health related quality of life
Health-related quality of life using the Immune Thrombocytopenic Purpura-Patient Assessment Questionnaire (ITP-PAQ)
Time frame: baseline and 26 weeks