NL-OMON39884已完成3 期
A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator*s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma - LUMIERE C14012- PTC
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or females, age * 18 years
- •2. Patients with PTCL according to WHO criteria and have relapsed or are refractory to at least 1 prior systemic, cytotoxic therapy for PTCL. Patients must have received conventional therapy as a prior therapy (ie, experimental therapy may not be the only prior therapy). Cutaneous-only disease is not permitted. Patients must have documented evidence of progressive disease
- •3. Tumor biopsy available for central hematopathologic review
- •4. Measurable disease according to the IWG criteria (See Section 15.4). Patients must have at least 1 site of disease measurable in 2 dimensions by computed tomography (CT)
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;Please see protocol for all inclusion criteria
排除标准
- •1. Known central nervous system (CNS) lymphoma
- •2. Systemic antineoplastic therapy, immunotherapy, investigational agent, or radiation therapy within 4 weeks of first dose of study treatment (6 weeks if nitrosoureas given) or concomitant use during study
- •3. Prior administration of an Aurora A kinase-targeted agent, including alisertib
- •4. Prior administration (whether in combination or as single-agent) of all 3 of the comparator drugs for the disease under study: pralatrexate, romidepsin, and gemcitabine;Please see protocol for all exclusion criteria
研究者
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