drugset / Trial / NCT01324596

A Randomised Evaluation of Molecular Guided Therapy for Diffuse Large B-cell Lymphoma With Bortezomib

NCT01324596

RandomizedParallel-groupOpen-labelTreatment

Summary

The aims of this study are: * To evaluate the benefits of the addition of bortezomib to standard rituximab with cyclophosphamide, doxorubicin, vincristine, prednisolone (R-CHOP) therapy in Diffuse Large B-cell Lymphoma (DLBCL). * To determine whether molecular phenotype effects the benefits derived from the addition of bortezomib.

Timeline

Start
2011-04
Primary completion
2015-04
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Intravenous
Subject Bortezomib Small molecule 1.6 mg/m2 Intravenous
Comparator Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Comparator Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Comparator Prednisolone Other / unclassified 100 mg Oral
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Comparator Vincristine Small molecule 1.4 mg/m2 Intravenous