Zanubrutinib and Eltrombopag as Second-line Treatment for Patients With Immune Thrombocytopenia: a Multicentre, Open-label,Randomised, Controlled, Phase 2 Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Treatment response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Willing and able to sign written informed consent
Exclusion Criteria
- •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
Arms & Interventions
Zanubrutinib and eltrombopag
Zanubrutinib 80mg po qd 6 weeks and eltrombopag 50 mg qd for up to 6 weeks.
Intervention: Zanubrutinib (Drug)
Zanubrutinib and eltrombopag
Zanubrutinib 80mg po qd 6 weeks and eltrombopag 50 mg qd for up to 6 weeks.
Intervention: Eltrombopag (Drug)
Eltrombopag monotherapy
Eltrombopag is given as 50 mg qd for up to 6 weeks.
Intervention: Eltrombopag (Drug)
Outcomes
Primary Outcomes
Treatment response
Time Frame: 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 Outcomes
- Overall response(6 weeks)
- Complete response (CR)(6 weeks)
- Sustained response(12 month)
- Number of patients with bleeding(12 months)
- Number of patients with adverse events(12 months)
- Duration of response (DOR)(12 months)
- Time to response(6 weeks)
- Loss of response(12 months)
Investigators
Xiao Hui Zhang
Vice president of Peking Univeristy Institute of Hematology
Peking University People's Hospital