drugset / Trial / NCT01563055
A Phase I/II, Open-label Study of Ofatumumab Added to Chlorambucil in Previously Untreated Japanese Patients With Chronic Lymphocytic Leukemia
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label study to evaluate tolerability, safety, efficacy and pharmacokinetic profile of ofatumumab in combination with chlorambucil in Japanese patients with previously untreated Chronic Lymphocytic Leukemia (CLL).
Timeline
- Start
- 2012-04
- Primary completion
- 2014-11
- Completion
- 2014-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Chlorambucil | Other / unclassified | 10 mg/m2 | Oral |
| Subject | Ofatumumab | Monoclonal antibody | 1000 mg | Intravenous |