EUCTR2013-002405-61-ES进行中（未招募）不适用
A Phase 3 Study of IPI-145 versus Ofatumumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Infinity Pharmaceuticals, Inc0 个研究点目标入组 307 人开始时间: 2013年12月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 307
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
- •1.Diagnosis of CLL or SLL that meets at least one of the IWCLL 2008 criteria for requiring treatment
- •2. Must have received at least one prior therapy for CLL/SLL
- •3. Measureable nodal disease by CT
- •4. ECOG performance status of 0-2
- •5. Considered not appropriate for treatment or retreament with purine analog-based therapy
- •6. Cytogenetics or Fish performed within 24 months prior to randomization
- •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 207
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1.History of Richter's transformation or prolymphocytic leukemia
- •2. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopath (ITP)
- •3.Prior allogeneic transplant
- •4.Known central nervous system (CNS) lymphoma or leukemia
- •5. Previous treatment with a PI3K inhibitor
- •6. Tyrosine kinase inhibitor within 7 days of randomization
- •7.Ongoing systemic bacterial, fungai, or viral infections at the time of treatment
- •8. Unable to receive prophylactic treatment for pneumocytosis or herpes simplex virus
- •9. History of tuberculosis within preceding two years
- •10.Prior, current or chronic hepatitis B or hepatitis C infection
- •11.History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months
研究者
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