drugset / Trial / NCT01466153
A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
RandomizedParallel-groupOpen-labelTreatment
Summary
The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to rituximab in the same population.
Timeline
- Start
- 2012-02-07
- Primary completion
- 2016-01-08
- Completion
- 2016-01-08
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Rituximab + Bendamustine vs MEDI-551 4 mg/kg + Bendamustine; p = 0.4475; Cochran-Mantel-Haenszel NCT01466153 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inebilizumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Inebilizumab | Monoclonal antibody | 4 mg/kg | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Background | Bendamustine | Small molecule | 70 mg/m2 | Intravenous |