NCT03670888终止1 期
"A Multicenter, Randomized, Double-blind, Parallel-controlled Trial to Compare the Bioequivalence and Safety of the Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody Injection (JHL1101) and Rituximab Injection in CD20 Positive B Cell Lymphoma Patients"
JHL Biotech, Inc.2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年11月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- AUC0~t
研究概览
简要总结
This is a multicenter, randomized, double-blind, parallel group study to compare the PK, safety, tolerability, immunogenicity and PD of JHL1101 vs Rituxan in subjects with CD20-positive B cell lymphoma. The study duration is 13 weeks. Approximately 128 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1101 (n=64) or Rituxan (n=64). Each subject will receive one intravenous (IV) infusions of the investigational product (IP) at the dose of 375mg/m2 on Day 1. Assessments of PK, safety, tolerability, immunogenicity, PD, and efficacy will be collected over the following 13-week period.
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
- Double (Participant, Investigator)
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
- •CD20-positive B-cell lymphoma.
- •Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy
- •18 years to 75 years
- •Signed an informed consent
- •Adequate organ function, including the following
- •Absolute neutrophil count (ANC) ≥ 1,500/uL; platelet count ≥ 75,000/uL; hemoglobin ≥ 8 g/dL
- •Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 times ULN
- •Serum creatinine ≤ 1.5 times the ULN
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Chemotherapy: must not have received within 8 weeks of entry onto this study
- •Radiotherapy: must not have received within 4 weeks of entry onto this study
- •Recovery (to baseline or to Grade 1 or less) from prior treatment-related toxicities except alopecia
- •Aagreement to practice contraception
- •More than 6 months life expectancy.
排除标准
- •Received any investigational drug within 28 days prior to study enrollment
- •Received blood transfusion or any therapies with erythropoietin (EPO), granulocyte-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to study enrollment
- •Received previous immunotherapy
- •Received or plan to receive a live vaccine within 28 days of study enrollment
- •Major surgery within 28 days of study enrollment
- •Received systemic steroid therapy with 28 days of study enrollment
- •Received or plan to receive the hematopoietic cell transplant
- •History of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment
- •Known allergic reactions against monoclonal antibody or rituximab.
- •Received rituximab or other anti-CD20 monoclonal antibody
- •Blood concentration of rituximab > 10 ug/mL during screen visit
- •Human immunodeficiency virus (HIV) positive
- •Hepatitis C virus (HCV) antigen and antibody positive
- •Hepatitis B virus surface antigen (HBsAg) positive
- •Body Mass Index (MBI) ≥ 28 kg/m2
结局指标
主要结局
AUC0~t
时间窗: 91 days
Area under the concentration-time curve (AUC) from time 0 (predose) of the first infusion on Day 1 to the last quantifiable concentration
次要结局
- Cmax(91 days)
- AUC0-∞(91 days)
研究者
研究点 (2)
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