drugset
drugset / Trial / NCT02268045

Study of RTXM83 Plus CHOP Chemotherapy Versus a Rituximab Plus CHOP Therapy in Patients With Non Hodgkin's Lymphoma

NCT02268045 ↗

Phase 3 Completed 272 enrolled mAbxience Research S.L. Actoverco · collabInnogene Kalbiotech Pte. Ltd · collabKey Oncologics (Pty) Ltd · collabLaboratorio Elea Phoenix S.A. · collabLaboratorios de Productos Éticos C.E.I.S.A. · collabLibbs Farmacêutica LTDA · collabNanolek LLC · collabPisa® Farmacéutica · collabTecnoquimicas S.A · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a multicenter, double-blind, randomized study comparing the efficacy, pharmacokinetics (PK)/pharmacodynamics (PD), safety and immunogenicity profile of RTXM83 (rituximab biosimilar) vs reference rituximab (MabThera®), both with CHOP, as first-line treatment of Diffuse-Large-B-Cell-Lymphoma (DLBCL). Rituximab biosimilar and MabThera® were both administered intravenously on Day 1 of each 3-week cycle with CHOP chemotherapy for six cycles. Two additional cycles of treatment were permitted at the Investigator's discretion. Patients were followed up for 9 months after last study dose.

Timeline

Start
2013-05
Primary completion
2016-05
Completion
2017-07

Drugs

EvaluationDrugModalityDoseRoute
Subject RTXM83 Unknown 375 mg/m2 Intravenous
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 750 mg/m2 —
Background Doxorubicin Other / unclassified 50 mg/m2 —
Background Prednisone Other / unclassified 40 mg/m2 —
Background Prednisone Other / unclassified 100 mg —
Background Vincristine Small molecule 1.4 mg/m2 —

Indications

diffuse large B-cell lymphoma