drugset / Trial / NCT01478542
OPTIMAL>60 / DR. CHOP, Improvement of Therapy of Elderly Patients with CD20+ DLBCL Using Rituximab Optimized and Liposomal Vincristine
Phase 3
Completed
1152 enrolled
Saarland University
German High-Grade Non-Hodgkin's Lymphoma Study Group · collabSpectrum Pharmaceuticals, Inc · collab
RandomizedFactorialOpen-labelTreatment
Summary
The purpose of this study is to improve the outcome of elderly patients with CD20-Aggressive B-Cell Lymphoma and to reduce the toxicity of standard used Immuno-Chemotherapy by using an optimised schedule of the monoclonal antibody Rituximab, substituting conventional by Liposomal Vincristine and by a PET-guided reduction of therapy in Combination with Vitamin D Substitution.
Timeline
- Start
- 2011-11
- Primary completion
- 2024-01-18
- Completion
- 2024-01-18
Publications
- Background Pfreundschuh, M., Christofyllakis, K., Altmann, B., Ziepert, M., Haenel, M., Viardot, A., Neubauer, A., Held, G., Truemper, L., Dreyling, M., Kanz, L., Hallek, M., Schmitz, N., Heintges, T., Kölbel, C., Buecker, A., Ruebe, C., Hellwig, D., Berdel, C., Poeschel, V., and Murawski, N. (2017) Radiotherapy to bulky disease PET-negative after immunochemotherapy in elderly DLBCL patients: Results of a planned interim analysis of the first 187 patients with bulky disease treated in the OPTIMAL>60 study of the DSHNHL. Hematological Oncology, 35( S2): 129- 130. doi: 10.1002/hon.2437_119.
- Kaddu-Mulindwa D, Altmann B, Held G, Angel S, Stilgenbauer S, Thurner L, Bewarder M, Schwier M, Pfreundschuh M, Loffler M, Menhart K, Grosse J, Ziepert M, Herrmann K, Duhrsen U, Huttmann A, Barbato F, Poeschel V, Hellwig D. FDG PET/CT to detect bone marrow involvement in the initial staging of patients with aggressive non-Hodgkin lymphoma: results from the prospective, multicenter PETAL and OPTIMAL>60 trials. Eur J Nucl Med Mol Imaging. 2021 Oct;48(11):3550-3559. doi: 10.1007/s00259-021-05348-6. Epub 2021 Apr 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Conventional Vincristine | Unknown | 1.4 mg/m2 | — |
| Subject | Liposomal Vincristine | Unknown | 1.4 mg/m2 | — |
| Subject | Liposomal Vincristine | Unknown | 1.67 mg/m2 | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |