A randomized, double-blind, phase III study comparing Biosimilar Rituximab (RTXM83) plus CHOP chemotherapy versus a reference Rituximab plus CHOP (R-CHOP) in patients with diffuse large b-cell lymphoma (DLBCL) given as first line.

MABXIENCE SA0 个研究点目标入组 250 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patients with measurable disease defined as existence of a unidimensional or bidimensional lesion greater than 2 cm in its longest diameter or malignant lymphocytosis greater than 5x109/L. Any other procedure for measurable disease in particular cases, may be allowed upon Sponsor approval.
•2.Newly diagnosed patients with a confirmed pathologic diagnosis of large B cell-non-Hodgkinâ??s lymphoma (DLBCL) with untreated CD20+. Defined by the local Haematopathologist at the local laboratory according to WHO criteria.
•3.Stage II-III or IV or stage I with bulk defined by the referring physician on the basis of the Cotswolds modification of the Ann Arbor classification.
•4.Age-adjusted International Prognostic Index (IPI) score 0 or 1.
•5.Age >=18 to <=65 years of age.
•6.Performance status (Eastern Cooperative Oncology Group [ECOG]) of <=2.
•7.Written informed consent obtained before starting any study specific procedure.
•8.Females of child-bearing potential must test negative on standard serum pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the study (e.g. oral contraceptive, double barrier method, intra-uterine device, intramuscular contraceptive).

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