EUCTR2020-000547-31-FR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
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
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
- •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
- •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
- •XML File Identifier: CDBOq7tmGWyTx23RYLAFvDUDelA=
- •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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 154
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 546
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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