NCT01701232已完成3 期
A Multicenter Open-label Randomized Study of BCD-020 (Rituximab, CJSC BIOCAD, Russia) Efficacy and Safety in Comparison With MabThera (F. Hoffmann-La Roche Ltd., Switzerland) in Monotherapy of CD20-positive Indolent Non-Hodgkin's Lymphoma
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biocad
- 入组人数
- 174
- 试验地点
- 111
- 主要终点
- Overall response rate
研究概览
简要总结
This international multi-center, randomized, controlled, open-label study investigated the pharmacokinetics, pharmacodynamics, efficacy and safety of BCD-020 (INN: rituximab, CJSC Biocad) versus MabThera® (INN: rituximab, F. Hoffmann La Roche, Ltd.) both administered as a monotherapy of patients with indolent non-Hodgkin's lymphoma.
Patients were randomized to receive 375 mg/m² BCD-020 as intravenous infusion once a week for 4 weeks or MabThera® at the same regimen.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having signed a written informed consent;
- •Patients' age is 18 years or more;
- •Diagnosis of CD20-positive indolent non-Hodgkin lymphoma of following morphological types:Follicular non-Hodgkin lymphoma stage II-IV according to Ann Arbor, grade I-II;Nodal marginal zone lymphoma stage II-IV according to Ann Arbor; Splenic marginal zone lymphoma.
- •Life expectancy of not less than 3 months after the enrollment in the study;
- •Morphological and immunohistochemical examination of the tumor (both lymph node biopsy and bone marrow biopsy) - within 3 months before the enrollment in the study ;
- •Performance status ≤2 on the ECOG scale;
- •Hemoglobin > 80 g/l; leukocyte count ≥ 3.0×109/l but less than 25×109/l, absolute neutrophil count ≥1.5×109/l, platelet count ≥100×109/l;
- •Presence of at least one measurable lesion;
- •Patient's ability in the investigator's opinion to comply with the protocol procedures;
- •Willingness of patients with preserved reproductive function to use reliable contraception methods (at least two contraception methods in women, e.g., spermicide and condom).
排除标准
- •Bulky disease - size of any single lesion more than 10 cm in the greatest diameter;
- •Secondary transformation to high-grade lymphoma;
- •Other types of non-Hodgkin lymphomas apart from follicular non-Hodgkin stage II-IV lymphoma according to Ann Arbor, grade 1,2; nodal marginal zone lymphoma stage II-IV according to Ann Arbor; splenic marginal zone lymphoma.
- •Patients regularly taking corticosteroids during 1 month preceding the enrollment in the study;
- •Occurrence of other (aside from NHL) diseases that can distort the assessment of the main disease symptoms expression; mask, enhance, modify the main disease symptoms or induce clinical and laboratory-instrumental symptoms similar to the non-Hodgkin lymphomas; Severe resistant hypertension; Decompensated forms of heart (NYHA class ХСН III, IV), liver and kidney disorders (creatinine level >133 µmol/l, AST, ALT, and bilirubin level 3 times exceeding the norm) except for the cases where the symptom is caused by lymphoma; Decompensated respiratory failure; Tumor infiltration of the lungs; Decompensated diabetes mellitus; Active autoimmune diseases; Ongoing infections requiring antimicrobial therapy.
- •Usage of the drugs:
- •At any time prior to the enrollment into the study - interferon-based drugs or monoclonal antibodies for the treatment of NHL; Chemotherapy or radiotherapy was completed less than 21 day prior to the enrollment into the study; Vaccination within 1 week prior to the enrollment into the study;
- •Presence of any psychiatric disorders including major depressive conditions and/or suicidal thoughts in anamnesis that in opinion of the investigator may put a patient at an excessive risk or influence the ability of patients to fulfill the study protocol;
- •Myocardial infarction less than 1 month before the enrollment into the study;
- •Severe CNS or PNS dysfunctions;
- •Drug and alcohol addiction;
- •Known HIV, HBV, HCV infection, syphilis;
- •Known primary or secondary immunodeficiency;
- •Primary CNS lymphoma or metastasis in the CNS;
- •Known intolerance or allergy to mouse proteins or any components of the study drugs, and also to the premedication drugs;
- •Pregnancy or lactation;
- •Prior or concomitant malignances except for adequately treated basal cell carcinoma and in situ cervical cancer;
- •Any restraints or impossibility to administer the study drug via an intravenous infusion;
- •Major surgery within 1 week prior to the enrollment into the study;
- •Simultaneous participation in any other clinical study or any preceding participation in other studies within 3 months prior to enrollment in this study.
研究组 & 干预措施
MabThera
Active Comparator
Reference rituximab at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1, 8, 15 and 22)
干预措施: rituximab (Biological)
BCD-020
Experimental
Proposed rituximab biosimilar at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1, 8, 15 and 22)
干预措施: rituximab (Biological)
结局指标
主要结局
Overall response rate
时间窗: day 50 (cycle 4)
Estimation of the overall response rate in each treatment arm at the end of treatment
CD20-positive cells count
时间窗: day 50
Comparison of peripheral blood B-cell depletion and repletion after BCD-020 and MabThera intravenous administration
次要结局
- Cmax(day 22)
- AUC(0-168)(168 hours)
- Complete response rate(day 50)
- Frequency of AEs/sAEs grade 3-4 (CTCAE v.4.03)(day 50)
- Levels of binding and neutralizing antibodies to rituximab(day 50)
- AUC(0-1176), AUC(0-inf)(day 50)
研究者
研究点 (111)
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