Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia

Peking University

Status and phase: Not yet enrolling; Phase 2

Conditions: Immune Thrombocytopenia

Treatments: Drug: Eltrombopag; Drug: Zanubrutinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05369377

Zan-Eltro-ITP

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

3. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Zanubrutinib and eltrombopag

Experimental group

Description:

Zanubrutinib 80mg po qd 6 weeks and eltrombopag 50 mg qd for up to 6 weeks.

Treatment:

Drug: Zanubrutinib

Drug: Eltrombopag

Eltrombopag monotherapy

Active Comparator group

Description:

Eltrombopag is given as 50 mg qd for up to 6 weeks.

Treatment:

Drug: Eltrombopag