A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 391
- 试验地点
- 76
- 主要终点
- PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013
研究概览
简要总结
The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
详细描述
Study PCYC-1112-CA is a randomized, multicenter, open-label, phase 3 study of the Bruton's Tyrosine Kinase (BTK) inhibitor Ibrutinib (PCI-32765) versus Ofatumumab in patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
Patients randomized to the ofatumumab arm may be considered to receive next subsequent therapy with ibrutinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status of 0-
- •Diagnosis of CLL or SLL that meets IWCLL 2008 criteria.
- •Active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment.
- •Must have received at least one prior therapy for CLL/SLL.
- •Considered not appropriate for treatment or retreatment with purine analog based therapy.
- •Measurable nodal disease by CT.
- •Patients must be able to receive outpatient treatment and laboratory monitoring at the institution that administers study drug for the entire study.
排除标准
- •Known CNS lymphoma or leukemia.
- •No documentation of cytogenetic and/or FISH in patient records prior to first dose of study drug.
- •Any history of Richter's transformation or prolymphocytic leukemia.
- •Uncontrolled Autoimmune Hemolytic Anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP).
- •Prior exposure to ofatumumab or to ibrutinib.
- •Prior autologous transplant within 6 months prior to first dose of study drug.
- •Prior allogeneic stem cell transplant within 6 months or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug.
- •History of prior malignancy, with the exception of certain skin cancers and malignancies treated with curative intent and with no evidence of active disease for more than 3 years.
- •Serologic status reflecting active hepatitis B or C infection.
- •Unable to swallow capsules or disease significantly affecting gastrointestinal function.
- •Uncontrolled active systemic fungal, bacterial, viral, or other infection.
- •History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.
- •Requires anticoagulation with warfarin.
研究组 & 干预措施
ibrutinib (Arm B)
A Bruton Tyrosine Kinase Inhibitor
干预措施: ibrutinib (Drug)
Ofatumumab (Arm A)
An anti-CD20 monoclonal antibody
干预措施: ofatumumab (Drug)
结局指标
主要结局
PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013
时间窗: Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled.
The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS) according to 2008 IWCLL guidelines.
次要结局
- Overall Response Rate (ORR) by Independent Review Committee (IRC)(About 18 months after the first subject was enrolled)
- OS (Overall Survival)(OS analysis was conducted at the time of study closure, including up to 6 years of study follow-up)
- Rate of Sustained Hemoglobin and Platelet Improvement(From study initiation to study closure, including up to 6 years of study follow-up)