التفاصيل البيبلوغرافية
| العنوان: |
A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma. |
| المؤلفون: |
JP Leonard, JW Friedberg, A Younes, D Fisher, LI Gordon, J Moore, M Czuczman, T Miller, P Stiff, BD Cheson, A Forero-Torres, N Chieffo, B McKinney, D Finucane, A Molina |
| المصدر: |
Annals of Oncology. Jul2007, Vol. 18 Issue 7, p1216-1216. 1p. |
| مصطلحات موضوعية: |
*MONOCLONAL antibodies, *MOLECULES, *LYMPHOMAS, *HODGKIN'S disease, *RITUXIMAB, *PHARMACOKINETICS |
| مستخلص: |
Background: Galiximab is a monoclonal antibody that targets CD80, a costimulatory molecule constitutively expressed on follicular and other lymphomas. Modest single-agent clinical activity and tolerability were demonstrated in a phase I study in relapsed or refractory, follicular non-Hodgkins lymphoma (NHL). A phase I/II study was conducted to evaluate galiximab in combination with a standard course of rituximab. Safety, pharmacokinetics, and efficacy were evaluated. Patients and methods: Patients with follicular NHL who had relapsed or failed primary therapy were enrolled. Rituximab-refractory patients (no response or a response with time to progression Results: Seventy-three patients received treatment. All had received at least one prior lymphoma therapy; 40% were rituximab naive. Infusions were delivered in an outpatient setting and were well tolerated. The most common study-related adverse events (AE) were lymphopenia, leukopenia, neutropenia, fatigue, and chills. The overall response rate at the recommended phase II dose of galiximab (500 mg/m2) was 66%: 19% complete response, 14% unconfirmed complete response, and 33% partial response. The median progression free survival was 12.1 months. Combination therapy did not appear to alter pharmacokinetics. Conclusion: These results indicate that galiximab can be safely combined with a standard course of rituximab. This doublet biologic approach offers the potential to avoid or delay chemotherapy or to integrate with other lymphoma therapies. A phase III, randomized study evaluating clinical benefit of rituximab versus the combination has been initiated. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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