Not yet recruiting NCT07315373
Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zanubrutinib 80mg/d, High dose dexamethasone, Zanubrutinib 160mg/d, Zanubrutinib 240mg/d.
- Who it may be relevant to
- Registry conditions: Immune Thrombocytopenia. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The FIND Study: A Dose-finding Study to Identify the Optimal Dose of Zanubrutinib in Adults With Immune Thrombocytopenia
Overview
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.
Interventions
- Drug Zanubrutinib 80mg/d
Zanubrutinib: 80 mg taken orally once daily for 26 weeks - 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. - Drug Zanubrutinib 160mg/d
Zanubrutinib: 160 mg taken orally once daily for 26 weeks - Drug Zanubrutinib 240mg/d
Zanubrutinib: 240 mg taken orally once daily for 26 weeks
Primary outcome measures
- Sustained response [Time frame: 26 weeks]
Secondary outcome measures (8)
- Initial Response (R) [Time frame: day 14]
- Initial complete response (CR) [Time frame: day 14]
- Time to response [Time frame: 6 month]
- Duration of response (DOR) [Time frame: 26 weeks]
- Bleeding events [Time frame: 26 weeks]
- Adverse events [Time frame: 26 weeks]
- Loss of response [Time frame: 26 weeks]
- Health related quality of life [Time frame: baseline and 26 weeks]
Eligibility criteria
Inclusion criteria
- Confirmed newly-diagnosed, treatment-naive ITP;
- Platelet counts <30×10\^9/L ;
- Platelet counts < 50×10\^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
- Willing and able to sign written informed consent.
Exclusion criteria
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
- Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
- Current HIV infection or hepatitis B virus or hepatitis C virus infections;
- Active infection;
- Maligancy;
- 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);
- 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
- 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;
- Patients who are deemed unsuitable for the study by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07315373 · ITP-Find Study