Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia

Официальное название

The FIND Study: A Dose-finding Study to Identify the Optimal Dose of Zanubrutinib in Adults With Immune Thrombocytopenia

Обзор

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.

Вмешательства

• Препарат Zanubrutinib 80mg/d
  Zanubrutinib: 80 mg taken orally once daily for 26 weeks
• Препарат 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.
• Препарат Zanubrutinib 160mg/d
  Zanubrutinib: 160 mg taken orally once daily for 26 weeks
• Препарат Zanubrutinib 240mg/d
  Zanubrutinib: 240 mg taken orally once daily for 26 weeks

Первичные конечные точки

• Sustained response [Срок оценки: 26 weeks]

Вторичные конечные точки (8)

• Initial Response (R) [Срок оценки: day 14]
• Initial complete response (CR) [Срок оценки: day 14]
• Time to response [Срок оценки: 6 month]
• Duration of response (DOR) [Срок оценки: 26 weeks]
• Bleeding events [Срок оценки: 26 weeks]
• Adverse events [Срок оценки: 26 weeks]
• Loss of response [Срок оценки: 26 weeks]
• Health related quality of life [Срок оценки: baseline and 26 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07315373 · ITP-Find Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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