NCT03003039已完成1 期
A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
Nanjing Yoko Biomedical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2017年6月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC) for GB241 and rituximab concentrations
研究概览
简要总结
The purpose of this study is the area under the curve (AUC) for GB241 and rituximab concentrations.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having histologically confirmed NHL expressing CD20 antigen
- •having obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy
- •signed an informed consent form which was approved by the institutional review board of the respective medical center
- •aged from 18 to 75 years
- •ECOG performance status of 0 to 1
- •expected survival of at least ≥ 3 months
排除标准
- •had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment
- •having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or have not recovered from significant toxicities of prior therapy
- •participating in other clinical trial within 30 days before enrolment
- •with serious hematologic dysfunction (white blood cell count of <3.0×103/uL; absolute neutrophil count of <1.5×103/ uL; platelet count of < 75×103/uL; hemoglobin level of < 8.0 g/dL); hepatic dysfunction (total bilirubin level of > 1.5×ULN; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of >2.5 × ULN; renal dysfunction (serum creatinine level of > 1.5×ULN ); and International normalized ratio (INR) and partial thromboplastin time or activated partial thromboplastin time (aPTT) > 1.5 × ULN (unless on therapeutic coagulation)
- •had received live vaccine within 4 weeks prior to study entry
- •with other malignancies ; or central nervous system (CNS) lymphoma, AIDS-related lymphoma; or active opportunistic infection, a serious nonmalignant disease
- •seropositive for HCV antibody, or HIV antibody, or hepatitis B virus surface antigen (HBsAg). HBc antibody seropositive, but HBV DNA and HBsAg negative patients may participle following consultation with a hepatitis expert regarding monitoring and use of HBV antiviral therapy, and provided they agree to receive treatment as indicated
- •recent major surgery (within 28 days prior to study entry )
- •with a history of allergic reaction or protein product allergy including murine proteins
- •pregnant or lactating or not accepted birth control methods including male patients
- •patients considered unsuitable by PI
- •previous malignant tumor except cured cervical cancer,basal cell carcinoma and squamous cell skin cancer
- •active opportunistic infections and other serious non neoplastic diseases
结局指标
主要结局
Area under the curve (AUC) for GB241 and rituximab concentrations
时间窗: 85 days
次要结局
- Maximum observed concentration of the GB241 and rituximab(85 days)
- AUC for GB241 and rituximab concentrations(1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks)
- Comparison of the incidence rate of HACA（host anti-chimeric antibody） between the two study arms(85 days)
- Degree of clearance from baseline of CD19+ , CD20+ B-cells between the two study arms(85 days)
- Comparison of AEs between the two study arms(85 days)
研究者
研究点 (1)
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