EUCTR2012-000711-88-ES进行中（未招募）不适用
A Phase 2, Multicenter, Single-Arm, Study to Evaluate the Efficacy and Safety of Single-Agent Bruton' s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects with Mantle Cell Lymphoma Who Progress after Bortezomib Therapy.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
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
- •- Diagnosis of confirmed mantle cell lymphoma (MCL) with at least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma.
- •- Must have received at least 1prior rituximab-containing chemotherapy regimen, but no more than 5 prior regimens.
- •- Must have received at least 2 cycles of bortezomib therapy (single-agent or in combination) and have documented progressive
- •disease during or after bortezomib therapy
- •- Eastern Cooperative Oncology Group performance status score 0, 1, or 2.
- •- Hematology and biochemical values within protocol-defined parameters.
- •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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 77
排除标准
- •- Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other
- •investigational agents within 3 weeks, or major surgery within 4 weeks of the first dose of study drug
- •- Prior treatment with ibrutinib or other Bruton´s tyrosine kinase inhibitors.
- •- More than 5 prior lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a >6 month treatment-free interval.
- •- Known central nervous system lymphoma.
- •- Diagnosed or treated for malignancy other than MCL, except malignancy treated with curative intent and with no known active disease present for >=3 years before the first dose of study drug and felt to be at low risk for recurrence by the treating physician, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, or adequately treated cervical carcinoma in situ without evidence of disease.
- •- History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.
- •- Requires anticoagulation with warfarin.
- •- Requires treatment with strong CYP3A4/5 or CYP2D6 inhibitors.
- •- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
- •- Known history of human immunodeficiency virus or active infection with hepatitis C virus or hepatitis B virus or any
- •uncontrolled active systemic infection.
- •- Any life-threatening illness, medical condition, or organ system
- •dysfunction which, in the investigator´s opinion, could compromise the patient´s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
研究者
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