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Phase I/II Study of Veltuzumab Combined With 90Y-Epratuzumab Tetraxetan in Patients With Relapsed/Refractory, Aggressive Non- Hodgkin's Lymphoma
The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab attack different areas on lymphoma cells. Because of this, treatment with the combination may provide more effective treatment in NHL than either veltuzumab or 90Y-epratuzumab given alone.
Details
| Lead sponsor | Gilead Sciences |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | WITHDRAWN |
| Start date | 2010-05 |
| Completion | 2017-03 |
Conditions
- Non Hodgkin's Lymphoma
- NHL
- Aggressive NHL
- Diffuse Large B-cell Lymphoma
Interventions
- Veltuzumab and 90Y-Epratuzumab Tetraxetan
- 90Y-epratuzumab tetraxetan
- veltuzumab
Primary outcomes
- Safety/dose limiting toxicity — 12 weeks
Patients are closely monitored during and after all infusions, and then at intervals over a 12-week post-treatment evaluation period. Safety evaluations required in all patients include vital signs, physical examination, CBC, serum chemistries, serum immunoglobulins, urinalysis, peripheral blood B-cell levels (immunophenotyping based on CD19), and HAHA (to be analyzed by Sponsor). Adverse events and abnormal laboratories will be graded for toxicity according to NCI CTC v3.0 criteria.
Countries
United States