drugset / Trial / NCT00562965
Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)
RandomizedParallel-groupOpen-labelHealth-services research
Summary
This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. Subjects will be randomized to one of these two arms of the study.
Timeline
- Start
- 2007-11
- Primary completion
- 2011-04
- Completion
- 2011-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Comparator | Dexamethasone | Small molecule | 20 mg | Oral |
| Comparator | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Subject | Inotuzumab Ozogamicin | Monoclonal antibody | 1.8 mg/m2 | Intravenous |
| Comparator | Mitoxantrone | Small molecule | 10 mg/m2 | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Comparator | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |
| Comparator | prednisone/prednisolone | Unknown | 40 mg/m2 | Oral |