EUCTR2017-000129-12-CZ
进行中（未招募）
1 期
Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with Mantle Cell Lymphoma
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Mantle Cell Lymphoma
- 发起方
- Pharmacyclics LLC
- 入组人数
- 362
- 状态
- 进行中（未招募）
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •For SRI and Randomization Phase
- •Disease\-Related
- •Pathologically confirmed MCL (in tumor tissue), with documentation of
- •either overexpression of cyclin D1 in association with other relevant
- •markers (eg, CD19, CD20, PAX5, CD5\) or evidence of t(11;14\) as
- •assessed by cytogenetics, fluorescent in situ hybridization (FISH), or
- •polymerase chain reaction (PCR).
- •At least 1 measurable site of disease that is \=2\.0 cm in the longest
- •diameter and measurable in 2 perpendicular dimensions per CT
- •At least 1, but no more than 5, prior treatment regimens for MCL
排除标准
- •For SRI and Randomization Phase
- •Disease\-Related
- •History or current evidence of central nervous system lymphoma
- •Concurrent Conditions
- •Concurrent enrollment in another therapeutic investigational study or
- •prior therapy with ibrutinib or other BTK inhibitors
- •Prior treatment with venetoclax or other BCL2 inhibitors
- •Anticancer therapy including chemotherapy, radiotherapy, small
- •molecule and investigational agents \=21 days prior to receiving the first
- •dose of study drug
结局指标
主要结局
未指定
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