EUCTR2020-000547-31-NL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
适应症
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-sponsored 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 BeiGenesponsored parent study.
- •b. At time of progressive disease (PD) after occurrence of either of the
- •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 (following discussion with the medical
- •monitor or designee of the parent study and this study)
- •*The following signs and symptoms may be indicators of non-clinically
- •significant progression warranting continued use of zanubrutinib despite
- •radiologic progression: absence of clinical symptoms and signs of
- •disease progression (including clinically significant worsening of
- •laboratory values), stable Eastern Cooperative Oncology Group
- •Performance Scale (ECOG PS), absence of rapid progression of disease
- •or of progressive tumor at critical anatomical sites that requires urgent
- •alternative medical intervention. In these scenarios, investigators must
- •inform patients that continuing treatment is not considered standard in
- •the treatment of cancer but that in the opinion of the investigator, the
- •patient will continue to benefit from zanubrutinib.
- •ii. Patient was receiving a non-BTK inhibitor drug at the time of PD, and
- •the investigator and patient agree that the patient may clinically benefit
- •from zanubrutinib treatment (following discussion with the medical
- •monitor or designee of the parent study and this study)
- •c. At an alternative timepoint for an alternative reason not described in
- •Inclusion Criteria 2a and 2b (following discussion with the medical
- •monitor or designee)
- •3. In the opinion of the investigator, the patient will continue to benefit
- •from, and tolerate zanubrutinib
- •a. Patient who is currently on zanubrutinib treatment:
- •Does not meet any criteria for zanubrutinib hold or permanent
- •discontinuation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 104
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 396
排除标准
- •1. Permanently discontinued from zanubrutinib treatment in the BeiGene-sponsored 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)
- •9. Vaccination with a live vaccine within 35 days prior to first dose of
研究者
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