drugset / Trial / NCT01562990

Phase Ib/II Study of the Efficacy and Safety of the R-CMC544/R-GEMOX Combination in Diffuse Lage B-cell Lymphoma at First or Second Relapse

NCT01562990

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the recommended dose of CMC544 administered in combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and oxaliplatin (R-GEMOX) in the first phase of the study. After that, efficacy and safety of this combination will be evaluated preliminarily in patients with DLBCL in relapse or refractory, who are no candidates for autologous transplant.

Timeline

Start
2012-12
Primary completion
2014-08
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule
Subject Inotuzumab Ozogamicin Monoclonal antibody
Subject Oxaliplatin Small molecule
Subject Rituximab Monoclonal antibody