NCT00452127终止1 期
An Open-Label, Multicenter, Phase I/II Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Have Been Treated With a Prior Rituximab-Containing Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 26
- 主要终点
- Dose-limiting toxicities and adverse events
研究概览
简要总结
This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with relapsed or refractory CD20-positive indolent NHL. The trial will enroll in two phases: a Phase I dose-escalation portion for patients with indolent NHL and a Phase II portion with enrollment of additional patients with follicular NHL into two expanded treatment cohorts in order to expand the safety database and collect preliminary anti-lymphoma activity data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- •Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab or radioimmunotherapy)
- •Prior use of any non-CD20-targeted monoclonal antibody therapy within 6 months of enrollment
- •Current or recent lymphoma treatment
- •History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
- •Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
- •Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination
- •Untreated or persistent/recurrent malignancy (other than lymphoma)
- •Known active bacterial, viral, fungal, mycobacterial, or other infection
- •A major episode of infection requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening
- •History of recurrent significant infection or bacterial infections
- •Positive hepatitis B or C serology
- •Positive human immunodeficiency virus (HIV) serology
- •Pregnancy or lactation
- •Central nervous system lymphoma
- •Recent major surgery within 4 weeks of screening, other than diagnostic surgery
研究组 & 干预措施
1
Experimental
干预措施: PRO131921 (Drug)
结局指标
主要结局
Dose-limiting toxicities and adverse events
时间窗: Length of study
次要结局
- Pharmacokinetic parameters; CD19-positive B-cell counts(Length of study)
- Overall response; and progression-free survival (Ph. 2 only)(Length of study)
研究者
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