drugset / Trial / NCT00227695
Rituximab in Treating Patients With Follicular Non-Hodgkin's Lymphoma
RandomizedParallel-groupOpen-labelTreatment
Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving rituximab over a short period of time is more effective than giving it over a long period of time in treating follicular non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying rituximab to see how well it works when given over a short period of time compared to when given over a long period of time in treating patients with follicular non-Hodgkin's lymphoma.
Timeline
- Start
- 2004-06-08
- Primary completion
- 2013-05-03
- Completion
- 2017-12-19
Publications
- Results Taverna CJ, Baasi S, Hitz F, et al.: First results of long-term rituximab maintenance treatment in follicular lymphoma: safety analysis of the randomized phase III trial SAKK 35/03. [Abstract] J Clin Oncol 27 (Suppl 15): A-8534, 2009.
- Results First results of long term rituximab maintenance treatment in follicular lymphoma: safety analysis of the randomized phase III trial SAKK 35/03. F. Hitz, S. Bassi, C. Taverna, W. Mingrone, T. Pabst, L. Cevreska, A. Del Giglio, D.A. Vorobiof, M. Simcock, M. Ghielmini Haematologica (2009) 94: s2; abstract 0413
- Results First results of long term rituximab maintenance treatment in follicular lymphoma: safety analysis of the randomized phase III trial SAKK 35/03. C.J. Taverna, S. Bassi, F. Hitz, W. Mingrone, T. Pabst, L. Cevreska, A. del Giglio, D.A. Vorobiof, M. Simcock, M. Ghielmini J Clin Oncol (2009) 27: 15s supplement; abstract 8534
- Results Rituximab maintenance treatment for a maximum of 5 years in follicular lymphoma: safety analysis of the randomized phase III trial SAKK 35/03. C. J. Taverna, S. Bassi, F. Hitz, W. Mingrone, T. Pabst, L. Cevreska, A. del Giglio, D.A. Vorobiof, M. Simcock, M. Ghielmini Blood (2010) 116: ASH Annual Meeting abstracts; abstract 1802
- Results Taverna C, Martinelli G, Hitz F, Mingrone W, Pabst T, Cevreska L, Del Giglio A, Vanazzi A, Laszlo D, Raats J, Rauch D, Vorobiof DA, Lohri A, Biaggi Rudolf C, Rondeau S, Rusterholz C, Heijnen IA, Zucca E, Ghielmini M. Rituximab Maintenance for a Maximum of 5 Years After Single-Agent Rituximab Induction in Follicular Lymphoma: Results of the Randomized Controlled Phase III Trial SAKK 35/03. J Clin Oncol. 2016 Feb 10;34(5):495-500. doi: 10.1200/JCO.2015.61.3968. Epub 2015 Dec 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |