The FIND Study: A Dose-finding Study to Identify the Optimal Dose of Zanubrutinib in Adults With Immune Thrombocytopenia
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Sustained response
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •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.
研究组 & 干预措施
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.
干预措施: Zanubrutinib 80mg/d (Drug)
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.
干预措施: High dose dexamethasone (Drug)
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.
干预措施: High dose dexamethasone (Drug)
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.
干预措施: Zanubrutinib 160mg/d (Drug)
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.
干预措施: High dose dexamethasone (Drug)
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.
干预措施: Zanubrutinib 240mg/d (Drug)
结局指标
主要结局
Sustained response
时间窗: 26 weeks
The maintenance of platelet count ≥ 30 x 10\^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 26-week follow-up.
次要结局
- Initial complete response (CR)(day 14)
- Duration of response (DOR)(26 weeks)
- Loss of response(26 weeks)
- Health related quality of life(baseline and 26 weeks)
- Initial Response (R)(day 14)
- Time to response(6 month)
- Bleeding events(26 weeks)
- Adverse events(26 weeks)
研究者
Xiao Hui Zhang
Vice president of Peking University Institute of Hematology
Peking University People's Hospital