EUCTR2013-000959-40-ES进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-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
- 800
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
- •- No prior treatment for diffuse B-cell lymphoma (DLBCL)
- •- Histologically-confirmed nongerminal center B-cell subtype DLBCL
- •- Stage II (not candidates for local x-ray therapy), III, or IV disease by the Ann Arbor Classification
- •- At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
- •- Revised International Prognostic Index score of >=1
- •- Eastern Cooperative Oncology Group performance status grade of 0, 1, or 2
- •- Hematology and biochemical laboratory values within protocol- efined parameters within 14 days prior to random assignment and at baseline
- •- Left ventricular ejection fraction within institutional normal limits, as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan
- •- Agrees to protocol-defined use of effective contraception (for women, these restrictions apply for 12 months after the last dose of rituximab or 1 month after the last dose of study drug, whichever is later; for men, these restrictions apply for 12 months
- •after the last dose of rituximab or 3 months after the last dose of study drug, whichever is later)
- •- Men must agree to not donate sperm during and after the study for 12 months after the last dose of rituximab or 3 months after the last dose of study drug, whichever is later
- •- Women of childbearing potential must have a negative serum or urine pregnancy test at screening
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •- Major surgery within 4 weeks of random assignment
- •- Known central nervous system or primary mediastinal lymphoma
- •- Prior history of indolent lymphoma
- •- Diagnosed or treated for malignancy other than DLBCL, except: malignancy treated with curative intent and with no known active disease present for >=3 years before random assignment; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of disease
- •- History of stroke or intracranial hemorrhage within 6 months prior to random assignment
- •- Requires anticoagulation with warfarin or equivalent vitamin K
- •antagonists
- •- Requires treatment with strong CYP3A4/5 inhibitors
- •- Prior anthracycline use >=150 mg/m2
- •- 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 hepatitis C virus or active hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous antibiotics
- •- Women who are pregnant or breastfeeding
- •- 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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