drugset / Trial / NCT01549886
Phase 2 Study of Zevalin Versus Zevalin and Motexafin Gadolinium in Patients With Rituximab-Refractory Low-grade or Follicular B-cell Non-Hodgkin's Lymphoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The objectives of this study are to evaluate the efficacy and safety of the Zevalin regimen compared to Zevalin and motexafin gadolinium in patients with rituximab-refractory, low-grade or follicular Non-Hodgkin's Lymphoma (NHL). Effectiveness of the experimental regimen assessed by complete response rate within 6 months of study entry (primary endpoint), complete response rate within 3 months of study entry, and overall response rate within 6 month of study entry.
Timeline
- Start
- 2011-11
- Primary completion
- 2014-06
- Completion
- 2015-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Moxtezafin Gadolinium | Unknown | 5 mg/kg | — |
| Background | 90Y-ibritumomab tiuxetan | Other / unclassified | 0.3 unknown | Intravenous |
| Background | 90Y-ibritumomab tiuxetan | Other / unclassified | 0.4 unknown | Intravenous |
| Background | Rituximab | Monoclonal antibody | 250 mg/m2 | Intravenous |