Clinical trial
Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine…
NCT00086580 · Genzyme, a Sanofi Company, Industry · Completed
Key facts
| NCT number | NCT00086580 |
|---|---|
| Title | Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients |
| Official title | A Phase III Randomized Trial to Evaluate the Efficacy and Safety of Second-Line Therapy With Fludarabine Plus Alemtuzumab vs. Fludarabine Alone in Patients With B-Cell Chronic Lymphocytic Leukemia |
| Lead sponsor | Genzyme, a Sanofi Company, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | B-Cell Chronic Lymphocytic Leukemia |
| Intervention type | Biological |
| Interventions | FluCAM [Fludara + Campath], fludarabine phosphate |
| Enrollment | 335 |
| Start date | Jul 1, 2004 |
| Primary completion | Jun 1, 2010 |
| Completion | Jun 1, 2010 |
| First posted | Jul 8, 2004 |
| Last update posted | Mar 13, 2014 |
| Countries | Austria, Bulgaria, Canada, Croatia, France, Germany, Greece, Italy, Poland, Portugal, Romania, Russia and 3 more |
At a glance
- 10–99 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: