drugset / Trial / NCT01580228
A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714)
RandomizedSingle-groupOpen-labelTreatment
Summary
This study is being conducted to demonstrate the superiority in progression-free survival (PFS) of dinaciclib compared to ofatumumab in chronic lymphocytic leukemia (CLL) participants with del 17p or in the overall population who are refractory to either fludarabine treatment or chemoimmunotherapy.
Timeline
- Start
- 2012-08
- Primary completion
- 2014-12
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dinaciclib | Small molecule | 14 mg/m2 | Intravenous |
| Comparator | Ofatumumab | Monoclonal antibody | 2000 mg | Intravenous |