NCT03456466Unknown1 期
A Multi-center, Randomized, Double-blind, Parallel Control Clinical Trial to Assess the Similarity of the Safety and Pharmacokinetics of TQB2303 in Combination With Rituximab to Patients With AggressiveCD20 Positive Non-Hodgkin's Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Vd
研究概览
简要总结
Primary Outcome Measures:
Area under the curve (AUC) forTQB2303 and rituximab concentrations [ Time Frame: 85 days ]
Secondary Outcome Measures:
The Maximum Concentration (Cmax) of the TQB2303 and rituximab [ Time Frame: 85 days ] The area under the plasma concentration-time curve from 0 to inf (infinite) time (AUC0-∞); The time to reach the maximum plasma concentration after treatment (Tmax) Total clearance (CL); Elimination of half-life (t1 / 2); Apparent distribution volume (Vd).
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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
- •Patients should participate in the study voluntarily and sign informed consent;
- •CD20-positive non-Hodgkin's lymphoma (NHL)：Diffuse Large B-cell Lymphoma；Mantle Cell Lymphoma；Follicular Lymphoma；Marginal Zone Lymphoma;
- •having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;And the investigators believe that CD20-positive B-cell NHL patients can benefit from anti-CD20 monoclonal antibody therapy;
- •aged from 18 to 75 years;
- •ECOG PS:0-1；
- •Life expectancy of more than 3 months
排除标准
- •Had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment;
- •patients who were treated with antitumor therapy (including corticosteroid therapy) within 4 weeks prior to enrollment, or who had not recovered from the toxicity of the previous treatment;
- •Patients who participated in other clinical studies within 30 days ;
- •Serious hematologic dysfunction (white blood cell count of <3.0×10^9/L; absolute neutrophil count of <1.5×10^9/L; platelet count of < 75×10^9/L; hemoglobin level of <80g/L); In the absence of anticoagulant therapy, International Standardization Ratio (INR)> 1.5× ULN;Partial prothrombin time (PTT)Or activated partial thromboplastin time (aPTT)> 1.5 × ULN;) Hepatic dysfunction (total bilirubin level of > 1.5 × upper limit of normal (ULN); aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of > 2.0 × ULN;) renal dysfunction (serum creatinine level of > 1.5×ULN );
- •Other invasive malignancies except for cured the IB or lower level of cervical cancer; Non-invasive basal cells or squamous cell skin cancer; Get CR> 10 years of breast cancer;Get CR> 10 years of malignant melanoma;or other malignancies with CR> 5 years;
- •Central nervous system (CNS) lymphoma, AIDS-associated lymphoma;
- •Active infections and other serious non-malignant tumor diseases, Such as Qualitative pneumonia, Severe organic cardiovascular disease, Heart conduction block > 2,Myocardial infarction in 6 months, Cerebral infarction in 3 months,Cerebral hemorrhage,Thyroid dysfunction (TSH lower than the normal lower limit or higher than the upper limit of normal, and the researchers have a clinical significance);
- •Seropositive for HIV , HCV antibody; Or one of the following HBV findings :
- •HBsAg positive;
- •HBsAg negative, HBcAb positive and HBV DNA positive;
- •Plan major surgery, or surgical wound unhealed patients;
- •History of severe allergies, protein products and mouse products such as allergies;
- •Pregnancy or breast feeding. Companion for women of childbearing age or women of childbearing age,who reluctant to take appropriate contraceptive methods within one year after the last treatment of the study;Pregnancy before pregnancy screening, the women who blood / urine results were positive;
- •Receipt of a live/attenuated vaccine within 4 weeks prior to the Screening Visit;
- •Researchers think that do not fit into the group.
研究组 & 干预措施
TQB2303
Experimental
干预措施: TQB2303 (Drug)
Rituximab
Active Comparator
干预措施: Rituximab (Drug)
结局指标
主要结局
Vd
时间窗: 85 days
Apparent distribution volume
t1/2
时间窗: 85 days
Elimination of half-life
Tmax
时间窗: 85 days
The time to reach the maximum plasma concentration after treatment
AUC
时间窗: 85 days
Area under the curve (AUC) forTQB2303 and rituximab concentrations
Cmax
时间窗: 85 days
The Maximum Concentration (Cmax) of the TQB2303 and rituximab
AUC0-∞
时间窗: 85 days
The area under the plasma concentration-time curve from 0 to inf (infinite) time
CL
时间窗: 85 days
Total clearance
次要结局
- Change of CD19+ CD20+ B-cells from baseline(85 days)
- Evaluation of immunogenicity(85 days)
研究者
研究点 (2)
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