EUCTR2012-000606-29-PL进行中（未招募）不适用
An Extension Study of Navitoclax (ABT-263) in Subjects with Chronic Lymphocytic Leukemia (CLL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 37
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
- •The subject has been dosing in Arm C of the ABT4710n study, has not discontinued for any reason prior to study closure and the investigator believes that continued treatment with navitoclax is in the best interest of the subject
- •The subject must meet defined hematology and coagulation lab criteria as specified in the protocol
- •The subject must meet defined chemistry criteria as specified in the protocol
- •Women of childbearing potential and men must agree to use adequate contraception (as per protocol) prior to study entry, for the duration of study participation and up to 90 days following completion of therapy
- •The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign the ICF
- •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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •The subject discontinued navitoclax administration in Arm C of the ABT4710n study for reasons of disease progression, AE toxicity, withdrawal of consent or PI decision prior to study completion.
- •The subject has any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
- •The subject is a lactating or pregnant female.
研究者
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