EUCTR2013-003093-27-GB进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination with Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects with Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
入选标准
- •- Histologically confirmed diagnosis of B-cell indolent Non-Hodgkin lymphoma with histological subtype limited to follicular lymphoma or marginal zone lymphoma, at initial diagnosis and without evidence of pathological transformation or clinical signs suggesting transformation
- •- At least 1 prior treatment with a CD20 antibody combination chemo-immunotherapy regimen
- •- Disease that has relapsed or was refractory after prior chemo-immunotherapy
- •- At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma 2007
- •- Eastern Cooperative Oncology Group performance status grade 0 or 1
- •- Laboratory values within protocol-defined parameters
- •- Agrees to protocol-defined use of effective contraception
- •- Men must agree not to donate sperm during and after the study for 6 months after the last dose of bendamustine, 12 months after the last dose of rituximab, or 3 months after the last dose of study medication, 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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •-Prior treatment according to protocol-defined criteria
- •-Unable to receive background chemotherapy based on prior treatment history and cardiac function
- •-Known central nervous system lymphoma
- •-Diagnosed or treated for malignancy other than indolent Non-Hodgkin lymphoma
- •-History of stroke or intracranial hemorrhage within 6 months prior to
- •randomization
- •-Requires anticoagulation with warfarin or equivalent Vitamin K antagonists
- •-Requires treatment with strong CYP3A inhibitors
- •-Clinically significant cardiovascular disease
- •-Known history of human immunodeficiency virus or active hepatitis C virus (HCV; ribonucleic acid [RNA] polymerase chain reaction [PCR]-positive) or active hepatitis B virus (HBV; DNA PCR-positive) infection or any uncontrolled active systemic infection regarding intravenous antibiotics
- •-Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
- •-Women who are pregnant or breastfeeding
研究者
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