EUCTR2017-000129-12-IT进行中（未招募）1 期
Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with Mantle Cell Lymphoma - Research study of Ibrutinib in Combination with Venetoclax in patients with Mantle Cell Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 287
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
- •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
- •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
- •Men and women = 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- •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 109
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 178
排除标准
- •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
研究者
相似试验
进行中（未招募）
1 期
Research study of Ibrutinib in Combination with Venetoclax in patients with Mantle Cell LymphomaMedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Mantle Cell LymphomaEUCTR2017-000129-12-NLPharmacyclics LLC362
进行中（未招募）
1 期
Research study of Ibrutinib in Combination with Venetoclax in patients with Mantle Cell LymphomaMedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Mantle Cell LymphomaEUCTR2017-000129-12-DEPharmacyclics LLC362
进行中（未招募）
1 期
Research study of Ibrutinib in Combination with Venetoclax in patients with Mantle Cell LymphomaMedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Mantle Cell LymphomaEUCTR2017-000129-12-BEPharmacyclics LLC362
进行中（未招募）
1 期
Research study of Ibrutinib in Combination with Venetoclax in patients with Mantle Cell LymphomaMedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Mantle Cell LymphomaEUCTR2017-000129-12-CZPharmacyclics LLC362
进行中（未招募）
1 期
Research study of Ibrutinib in Combination with Venetoclax in patients with Mantle Cell LymphomaMedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Mantle Cell LymphomaEUCTR2017-000129-12-GBPharmacyclics LLC362