drugset / Trial / NCT01171378
Study of Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) With Ofatumumab in Patients With Richter's Syndrome
Phase 2
Completed
43 enrolled
University of Oxford
Cancer Research UK · collabGlaxoSmithKline · collabNCRI CLL Subgroup · collabOxford University Hospitals NHS Trust · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ofatumumab | Monoclonal antibody | 300 mg | Intravenous |
| Subject | Ofatumumab | Monoclonal antibody | 1000 mg | Intravenous |