drugset / Trial / NCT01171378

Study of Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) With Ofatumumab in Patients With Richter's Syndrome

NCT01171378

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate Ofatumumab in combination with CHOP (cyclophosphamide, hydroxydaunorubicin (doxorubicin), Oncovin (vincristine), and prednisone/prednisolone, the standard chemotherapy treatment) in induction and maintenance treatment of Richter's Syndrome. This study aims to evaluate the overall response rate to CHOP-O (CHOP in combination with Ofatumumab) according to the Revised Response Criteria for Malignant Lymphoma. The hypothesis would be that treatment with CHOP-O for Richter's Syndrome (RS), shows a difference in overall survival (more people living longer), when compared with the standard treatment of CHOP-R (CHOP chemotherapy plus Rituximab).

Timeline

Start
2011-04
Primary completion
2015-02
Completion
2016-04-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Ofatumumab Monoclonal antibody 300 mg Intravenous
Subject Ofatumumab Monoclonal antibody 1000 mg Intravenous