drugset / Trial / NCT01014208
Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is being conducted to compare the efficacy and safety of ofatumumab in addition to salvage chemotherapy versus rituximab in addition to salvage chemotherapy in CD20 positive DLBCL subjects relapsing, or with persistent disease, after first-line treatment with rituximab combined with an anthracycline-based chemotherapy regimen and be eligible for ASCT.
Timeline
- Start
- 2010-03
- Primary completion
- 2014-02
- Completion
- 2014-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ofatumumab | Monoclonal antibody | 1000 mg | — |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | — |
| Background | Cytarabine | Small molecule | 2 g | — |
| Background | Dexamethasone | Small molecule | 40 mg | — |