NCT02456207Unknown2 期
A Phase II, Multi-center, Randomized and Open Study to Evaluate and Compare the PK, PD and Safety of SCT400 With Rituximab in Patients With CD20+ B-cell Non-Hodgkin's Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC) for SCT400 and rituximab concentrations
研究概览
简要总结
The primary objective of the study is to assess the pharmacokinetic (PK) similarity of SCT400 versus rituximab (MabThera®) in patients with CD20+ B-cell Non-Hodgkin's Lymphoma.
The secondary objective of the study is to evaluate the pharmacodynamics (PD) and safety of SCT400 versus rituximab (MabThera®), as well as the presence of human anti-chimeric antibodies (HACA).
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
- •aged from 18 to 75 years;
- •having histologically confirmed NHL expressing CD20 antigen;
- •having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;
- •ECOG performance status of 0 to 1
- •expected survival of at least ≥ 3 months;
- •signed an informed consent form which was approved by the institutional review board of the respective medical center .
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.
研究组 & 干预措施
Experimental
Experimental
SCT400:375 mg/m2, iv, one infusion
干预措施: SCT400 (Drug)
Active Comparator
Active Comparator
Rituximab: 375 mg/m2, iv, one infusion
干预措施: Rituximab (Drug)
结局指标
主要结局
Area under the curve (AUC) for SCT400 and rituximab concentrations
时间窗: 85 days
次要结局
- Comparison of AEs between the two study arms(85 days)
- Comparison of HACA between the two study arms(85 days)
- Change from baseline of CD19+ , CD20+ B-cells(85 days)
- AUC for SCT400 and rituximab concentrations(1 week ,2 weeks, 4 weeks, 8 weeks and 12 weeks)
- Maximum observed concentration of the SCT400 and rituximab(85 days)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
Clinical Trial in Chinese Healthy Volunteers of GB222Non-small Cell Lung CancerNCT04175158Genor Biopharma Co., Ltd.84
Unknown
1 期
Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia AHemophilia ANCT02888223Sinocelltech Ltd.16
终止
2 期
Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19COVID-19NCT05124210GlaxoSmithKline8
已完成
1 期
A Study to Investigate the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants.Healthy ParticipantsNCT06531811AstraZeneca32
已完成
1 期
A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III MelanomaMelanomaNCT06153238Sandoz322