Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with Mantle Cell Lymphoma

Pharmacyclics LLC0 个研究点目标入组 362 人2017年8月17日

概览

暂无简介。

注册库

who.int

开始日期

2017年8月17日

结束日期

待定

最后更新

去年

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•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 on cross\-sectional imaging 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 including at least 1 prior rituximab/anti\-CD20 containing regimen
•Failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen
•Subjects must have adequate fresh or paraffin embedded tissue.
•Adequate hematologic function
•Adequate hepatic and renal function
•Demographic

•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
•Treatment with any of the following within 7 days prior to the first dose of study drug:
•o moderate or strong cytochrome P450 3A (CYP3A) inhibitors
•o moderate or strong CYP3A inducers