Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia

Peking University

Status and phase: Not yet enrolling; Phase 1

Conditions: Immune Thrombocytopenia

Treatments: Drug: High dose dexamethasone; Drug: Zanubrutinib 80mg/d; Drug: Zanubrutinib 160mg/d; Drug: Zanubrutinib 240mg/d

Study type: Interventional

Funder types: Other

Identifiers

NCT07315373

ITP-Find Study

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Zanubrutinib 80mg/d + Dexamethasone

Experimental group

Description:

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.

Treatment:

Drug: Zanubrutinib 80mg/d

Drug: High dose dexamethasone

Zanubrutinib 160mg/d + Dexamethasone

Experimental group

Description:

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.

Treatment:

Drug: Zanubrutinib 160mg/d

Drug: High dose dexamethasone

Zanubrutinib 240mg/d + Dexamethasone

Experimental group

Description:

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.

Treatment:

Drug: Zanubrutinib 240mg/d

Drug: High dose dexamethasone