Clinical trial
Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients
NCT00410163 · GlaxoSmithKline, Industry · Completed
Key facts
| NCT number | NCT00410163 |
|---|---|
| Title | Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients |
| Official title | An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With Fludarabine and Cyclophosphamide, in Patients With Previously Untreated B-cell CLL |
| Acronym | BIFROST |
| Lead sponsor | GlaxoSmithKline, Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Leukaemia, Lymphocytic, Chronic |
| Intervention type | Drug |
| Interventions | Ofatumumab 500mg, Ofatumumab 1000mg, Fludarabine, Cyclophosphamide |
| Enrollment | 61 |
| Start date | Jan 1, 2007 |
| Primary completion | Mar 1, 2009 |
| Completion | May 1, 2013 |
| First posted | Dec 12, 2006 |
| Last update posted | Feb 10, 2014 |
| Countries | United Kingdom, United States |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: