Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia
- Conditions
- Immune Thrombocytopenia
- Interventions
- Registration Number
- NCT05369377
- Lead Sponsor
- Peking University People's Hospital
- Brief Summary
Randomized, open-label, multicenter study to compare the efficacy and safety of zanubrutinib plus eltrombopag compared to eltrombopag monotherapy for the first-line treatment of adults with chronic immune thrombocytopenia (ITP).
- Detailed Description
The investigators are undertaking a prospective trial of patients with ITP in China. Zanubrutinib is administered as 80 mg po. qd for 6 weeks. Eltrombopag is given with 50 mg once daily for up to 6 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. This study assessed the efficacy and safety of eltrombopag plus zanubrutinib.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
-
Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
-
Patients with chronic low platelet count (less than 30,000/µL) for 6 months who have failed at least one treatment for chronic low platelet count
-
Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation 3. Willing and able to sign written informed consent
- Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
- congestive heart failure
- severe arrhythmia
- nursing or pregnant women
- aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
- creatinine or serum bilirubin levels each 1•5 times or more than the normal range
- active or previous malignancy
- Unable to do blood routine test for the sake of time, distance, economic issues or other reasons
- History of clotting disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zanubrutinib and eltrombopag Zanubrutinib Zanubrutinib 80mg po qd 6 weeks and eltrombopag 50 mg qd for up to 6 weeks. Zanubrutinib and eltrombopag Eltrombopag Zanubrutinib 80mg po qd 6 weeks and eltrombopag 50 mg qd for up to 6 weeks. Eltrombopag monotherapy Eltrombopag Eltrombopag is given as 50 mg qd for up to 6 weeks.
- Primary Outcome Measures
Name Time Method Treatment response 6 weeks The proportion of patients who had an increase in platelet counts to 50 000 per μL or more after 6 weeks of treatment
- Secondary Outcome Measures
Name Time Method Overall response 6 weeks 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 after 6 weeks of treatment
Complete response (CR) 6 weeks Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding
Sustained response 12 month 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 12-month follow-up
Number of patients with bleeding 12 months Number of patients with bleeding complication ( WHO bleeding score)
Number of patients with adverse events 12 months Number of patients with adverse events
Duration of response (DOR) 12 months Duration of response at 12-month follow up
Time to response 6 weeks The time from starting treatment to time of achievement of Response
Loss of response 12 months 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)
Trial Locations
- Locations (1)
Peking University Insititute of Hematology, Peking University People's Hospital
🇨🇳Beijing, Beijing, China