A Randomised, Multi-centre, Double-blind, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of Two Anti-CD20 Monoclonal Antibodies in Combination with CHOP in Patients with CD20-Positive Diffuse Large B-cell Lymphoma

Dr Reddys Laboratories Ltd36 个研究点分布在 1 个国家目标入组 190 人开始时间: 2012年11月21日最近更新: 2017年10月31日

试验速览

阶段: 不适用
状态: 已完成
发起方: Dr Reddys Laboratories Ltd
入组人数: 190
试验地点: 36
主要终点: To evaluate the PK equivalence of two anti CD-20 antibodies [DRL-rituximab(Redituxâ„¢)and MabTheraÂ®]

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a multi-centre, double-blind, parallel group, randomised comparative study of the pharmacokinetics,pharmacodynamics, safety and efficacy ofDRL-rituximab (Redituxâ„¢)and MabTheraÂ®. All study patients will also be administered cyclical combination chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisolone [CHOP]) which represents the standard of care for the disease condition. The disease condition will be monitored at standard intervals and patients requiring alternative therapy for any reason will be promptly removed from the study.

研究设计

研究类型: Interventional
分配方式: Stratified randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•1.Adult male or female patients 18 to 60 years of age (both inclusive), with histologically confirmed CD20+ diffuse large B-cell lymphoma.
•2.Eastern Cooperative Oncology Group (ECOG, also referred to as Zubrod) performance status of 0, 1, or 2 3.Stage II, III, or IV by the Ann Arborclassification (Cotswold modification) 4.Adequate liver and renal function 5.Ability to comply with all study requirements 6.Signed and dated informed consent.

排除标准

•1.Diffuse large B-cell lymphoma that is primary CNS, effusional, or intravascular according to the WHO, 2008 classification 2.Diffuse lymphoma for which CHOP is not adequate therapy 3.Bulky Disease 4.Any CNS involvement by lymphoma 5.Severe active infection 6.Pregnant or lactating women or women trying to become pregnant during the study.

结局指标

主要结局

To evaluate the PK equivalence of two anti CD-20 antibodies [DRL-rituximab(Redituxâ„¢)and MabTheraÂ®]

时间窗: 3 weeks

次要结局

To assess the objective response rate (ORR) at 6 cycles as defined by Revised Response Criteria for Malignant Lymphoma (Cheson, 2007)(18 weeks)

研究者

发起方

Dr Reddys Laboratories Ltd

申办方类型

Pharmaceutical industry-Indian

研究点 (36)

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