drugset / Trial / NCT02617485
MabionCD20 Compared to MabThera in Lymphoma Patients
RandomizedParallel-groupTriple-blindTreatment
Summary
The aim of the study is to demonstrate the high level of biosimilarity between MabionCD20 (MABION SA) and the reference product: MabThera (rituximab by Hoffman-La Roche) in patients with CD20-positive diffuse large B-cell lymphoma.
Timeline
- Start
- 2015-12
- Primary completion
- 2017-08
- Completion
- 2018-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Background | Prednisone | Other / unclassified | 100 mg | Oral |
| Background | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |