Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia

NCT ID: NCT07315373

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-25
• Study Completion Date: 2029-06-30

Brief Summary

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.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Zanubrutinib 80mg/d + Dexamethasone

Participants in this arm will receive a combination therapy consisting of:

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.

Group Type: EXPERIMENTAL

Zanubrutinib 80mg/d

Intervention Type: DRUG

Zanubrutinib: 80 mg taken orally once daily for 26 weeks

High dose dexamethasone

Intervention Type: DRUG

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 160mg/d + Dexamethasone

Participants in this arm will receive a combination therapy consisting of:

Zanubrutinib: 160 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.

Group Type: EXPERIMENTAL

High dose dexamethasone

Intervention Type: DRUG

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 160mg/d

Intervention Type: DRUG

Zanubrutinib: 160 mg taken orally once daily for 26 weeks

Zanubrutinib 240mg/d + Dexamethasone

Participants in this arm will receive a combination therapy consisting of:

Zanubrutinib: 240 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.

Group Type: EXPERIMENTAL

High dose dexamethasone

Intervention Type: DRUG

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 240mg/d

Intervention Type: DRUG

Zanubrutinib: 240 mg taken orally once daily for 26 weeks

Interventions

Zanubrutinib 80mg/d

Zanubrutinib: 80 mg taken orally once daily for 26 weeks

Intervention Type: DRUG

High dose dexamethasone

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.

Intervention Type: DRUG

Zanubrutinib 160mg/d

Zanubrutinib: 160 mg taken orally once daily for 26 weeks

Intervention Type: DRUG

Zanubrutinib 240mg/d

Zanubrutinib: 240 mg taken orally once daily for 26 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Confirmed newly-diagnosed, treatment-naive ITP;

2. Platelet counts <30×10^9/L ;

3. Platelet counts < 50×10^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);

4. Willing and able to sign written informed consent.

Exclusion Criteria

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;

2. Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;

3. Current HIV infection or hepatitis B virus or hepatitis C virus infections;

4. Active infection;

5. Maligancy;

6. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);

7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy

8. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;

9. Patients who are deemed unsuitable for the study by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao Hui Zhang

Vice president of Peking University Institute of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaohui Zhang

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology

Central Contacts

Xiaohui Zhang, MD

Role: CONTACT

zhangxh100@sina.com

8688324577

Qiusha Huang, MD

Role: CONTACT

huangfuqs@163.com

8688324577

Other Identifiers

ITP-Find Study

Identifier Type: -

Identifier Source: org_study_id