EUCTR2020-000547-31-GB进行中（未招募）1 期
An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients with B cell Malignancies - BGB-3111-LTE1
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. As part of a BeiGene parent study:
- •a. Currently participating, or
- •b. Participated recently
- •2. Intent to continue or start zanubrutinib treatment after occurrence of any of the following:
- •a. At time of final analysis or study closure of the eligible BeiGene parent study:
- •For zanubrutinib-naive patients, rationale for initiation of zanubrutinib treatment must be discussed with and approved by the medical monitor
- •b. At time of progressive disease (PD) after occurrence of either of the following:
- •i Patient was receiving zanubrutinib at the time of progressive disease (PD), and the investigator and patient agree it is in the patient’s best interest to continue zanubrutinib (discussion with and approval by the medical monitors of the parent study and this study required)
- •ii Patient was receiving a non-BTK inhibitor drug at the time of progressive disease (PD), and the investigator and patient agree that the patient may clinically benefit from zanubrutinib treatment (discussion with and approval by the medical monitors of the parent study and this study required)
- •c. At an alternative timepoint for an alternative reason (discussion with and approval by the medical monitor required)
- •3. Patient who is currently on zanubrutinib treatment:
- •Does not meet any criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit from zanubrutinib treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 422
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 78
排除标准
- •1. Permanently discontinued from zanubrutinib treatment in the BeiGene parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent
- •2. Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy
- •3. Life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk
- •4. Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapy, or any prohibited concomitant therapy outlined in the protocol
- •5. Pregnant or lactating woman
- •6. Inability to comply with study procedures
- •7. Concurrent participation in another therapeutic clinical study
- •8. History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)
研究者
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