EUCTR2016-003202-14-IT进行中（未招募）1 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Rituximab versus Placebo in Combination with Rituximab in Treatment Naïve Subjects with Follicular Lymphoma - PERSPECTIVE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
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
- •* Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease.
- •* Measurable disease.
- •* Subjects 70 years of age or older with any comorbidity per investigator medical judgment; OR subjects 60-69 years of age who have one or more comorbidities that make them a candidate to receive single-agent rituximab therapy.
- •* Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
- •* Adequate hematologic function within protocol-defined parameters.
- •* Adequate hepatic and renal function within protocol-defined parameters.
- •* ECOG performance status score of 0-2.
- •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 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •* Transformed lymphoma.
- •* Prior treatment for follicular lymphoma.
- •* Central nervous system lymphoma or leptomeningeal disease.
- •* Currently active, clinically significant cardiovascular disease
研究者
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