Clinical trial NCT05369377: Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia
Official title: Zanubrutinib and Eltrombopag as Second-line Treatment for Patients With Immune Thrombocytopenia: a Multicentre, Open-label,Randomised, Controlled, Phase 2 Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Immune Thrombocytopenia
Keywords: BTK inhibitor
Thrombopoietin-receptor agonist
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Hospital
name: Navy General Hospital, Beijing
name: Beijing Aerospace General Hospital
name: Qilu Hospital of Shandong University
name: Beijing Tongren Hospital
First posted: 2022-05-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
2. 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

2. 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

Exclusion Criteria:

1. Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
2. congestive heart failure
3. severe arrhythmia
4. nursing or pregnant women
5. aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
6. creatinine or serum bilirubin levels each 1•5 times or more than the normal range
7. active or previous malignancy
8. Unable to do blood routine test for the sake of time, distance, economic issues or other reasons
9. History of clotting disorder

Primary outcomes:
measure: Treatment response
timeFrame: 6 weeks
Secondary outcomes:
measure: Overall response
timeFrame: 6 weeks
measure: Complete response (CR)
timeFrame: 6 weeks
measure: Time to response
timeFrame: 6 weeks
measure: Sustained response
timeFrame: 12 month
measure: Number of patients with bleeding
timeFrame: 12 months
measure: Number of patients with adverse events
timeFrame: 12 months
measure: Duration of response (DOR)
timeFrame: 12 months
measure: Loss of response
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Insititute of Hematology, Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital, Peking University Insititute of Hematology
name: Xiaohui Zhang, md
role: PRINCIPAL_INVESTIGATOR
References: