CTRI/2019/05/019044已完成3 期
A Randomised, Double-blind, Parallel-group, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) with MabThera® in Subjects with Previously Untreated, Stage II-IV, Cluster of Differentiation (CD)20-Positive, Low Tumour Burden Follicular Lymphoma - FLINTER
Dr Reddys Laboratories SA0 个研究点目标入组 33 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1)Subject is Male or female subjects aged greater than or equals to 18 years of age.
- •2)Subject is histologically confirmed, Grade 1-3a, previously untreated, CD20-positive.
- •3)Subject has Ann Arbor Stage II to IV and ECOG status of 0 to 1.
- •4)Subject has Low tumor burden follicular lymphoma as per Groupe dEtude des Lymphomes Folliculaires (GELF) Criteria
- •5)Subject has at least 1 measurable tumor mass in 2 dimensions, and the mass must be:
- •a) Nodal lesion greater than 15 mm in the longest dimension; or
- •b) Nodal lesion >10 mm to less than or equals to 15 mm in the longest dimension and >10 mm in the shortest dimension
- •c) Extra-nodal lesion with both long and short dimensions greater than or equals to 10 mm.
- •6)Subject has Life expectancy greater than or equals to 3 months.
- •7)If female subject, then subject should be non pregnant, non lactating.
排除标准
- •1)Subject with prior use of rituximab or any CD20 monoclonal antibody for any reason.
- •2)Subjects with known hypersensitivity to rituximab or its excipients, or to proteins of murine or other foreign origin.
- •3)Any prior therapy for follicular lymphoma (including but not limited to chemotherapy, radiotherapy) or subjects on chronic supra-substitutive doses of systemic gluco-corticosteriods.
- •4)Subjects who, in the opinion of the Investigator, require additional concomitant treatment for lymphoma.
- •5)Evidence of histologic transformation to high grade lymphoma or diffuse large B-cell lymphoma.
- •6) Subjects with known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV).
- •Subjects with positive serological test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C virus (HCV) antibody can only be included in the study only if the criteria mentioned in the protocol are met.
- •7) Subjects who received a live vaccine within last 3 months of the first administration of study drug except vaccine against COVID-19.
- •8)Subjects with history or presence of a medical condition or disease that in the Investigators opinion would place the subject at an unacceptable risk for study participation.
- •9)Participation in any clinical study or having taken any investigational therapy (within 2 months of the first dose of study drug).
- •10)Women of childbearing potential who do not consent to use highly effective methods of birth control
研究者
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