EUCTR2018-004356-38-DK进行中（未招募）1 期
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 550
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
- •- Subject has completed a prior venetoclax study, and the investigator believes that continued treatment with venetoclax is in the best interest of the patient.
- •- Subjects are willing or able to comply with procedures required in this protocol.
- •- Subjects entering the extension study with multiple myeloma must adhere to the following guidelines:
- •All subjects receiving treatment with venetoclax in combination with a proteasome inhibitor must receive prophylaxis with antibiotics while on treatment and for at least 30 days after discontinuation of the proteasome inhibitor and/or venetoclax including:
- •Bactrim forte® (1 tablet, 3 times a week) or equivalent antibiotic therapy AND
- •Amoxicillin clavulanate (500 mg to 1 g, twice daily) or levofloxacin (500 mg once daily, adjusted for renal function) or equivalent antibiotic therapy per institutional guidelines
- •- Subjects or their legally authorized representative must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
- •Subjects agree to abide by protocol-mandated pregnancy avoidance measures.
- •Are the trial subjects under 18? yes
- •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 294
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •Female who is pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
- •Male who is considering fathering a child or donating sperm during the study or for approximately 90 days after the last dose of study drug.
- •Subjects receiving any live vaccines during study participation including until at least 4 weeks (for all indications except MM) and 8 weeks (for subjects with MM) after the last dose of study drug.
研究者
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