drugset / Trial / NCT00410163
Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
To investigate the safety and efficacy of two dose regimes of ofatumumab in combination with chemotherapy in previously untreated patients with B-CLL
Timeline
- Start
- 2007-01
- Primary completion
- 2009-03
- Completion
- 2013-05
Publications
- Background Wierda WG, Kipps TJ, Durig J, Griskevicius L, Stilgenbauer S, Mayer J, Smolej L, Hess G, Griniute R, Hernandez-Ilizaliturri FJ, Padmanabhan S, Gorczyca M, Chang CN, Chan G, Gupta I, Nielsen TG, Russell CA; 407 Study Investigators. Chemoimmunotherapy with O-FC in previously untreated patients with chronic lymphocytic leukemia. Blood. 2011 Jun 16;117(24):6450-8. doi: 10.1182/blood-2010-12-323980. Epub 2011 Apr 15.
- Jewell RC, Kipps TJ, Durig J, Griskevicius L, Stilgenbauer S, Smolej L, Mayer J, Hess G, Hernandez-Ilizaliturri FJ, Padmanabhan-Iyer S, Fang L, Goldstein N, Gorczyca M, Gupta I, Lisby S, Wierda WG; Hx-CD20-407 Study Investigators. Associations of ofatumumab exposure and treatment outcomes in patients with untreated CLL receiving chemoimmunotherapy. Leuk Lymphoma. 2017 Feb;58(2):348-356. doi: 10.1080/10428194.2016.1195497. Epub 2016 Jul 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ofatumumab | Monoclonal antibody | 500 mg | Intravenous |
| Comparator | Ofatumumab | Monoclonal antibody | 1000 mg | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 250 mg/m2 | Intravenous |
| Comparator | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |