drugset / Trial / NCT01324596
A Randomised Evaluation of Molecular Guided Therapy for Diffuse Large B-cell Lymphoma With Bortezomib
Phase 3
Completed
1132 enrolled
University Hospital Southampton NHS Foundation Trust
Janssen-Cilag Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The aims of this study are: * To evaluate the benefits of the addition of bortezomib to standard rituximab with cyclophosphamide, doxorubicin, vincristine, prednisolone (R-CHOP) therapy in Diffuse Large B-cell Lymphoma (DLBCL). * To determine whether molecular phenotype effects the benefits derived from the addition of bortezomib.
Timeline
- Start
- 2011-04
- Primary completion
- 2015-04
- Completion
- 2015-06
Publications
- Davies AJ, Barrans S, Stanton L, Caddy J, Wilding S, Saunders G, Mamot C, Novak U, McMillan A, Fields P, Collins GP, Stephens R, Cucco F, Sha C, van Hoppe M, Tooze R, Davies JR, Griffiths G, Schuh A, Burton C, Westhead DR, Du MQ, Johnson PWM. Differential Efficacy From the Addition of Bortezomib to R-CHOP in Diffuse Large B-Cell Lymphoma According to the Molecular Subgroup in the REMoDL-B Study With a 5-Year Follow-Up. J Clin Oncol. 2023 May 20;41(15):2718-2723. doi: 10.1200/JCO.23.00033. Epub 2023 Mar 27.
- Davies A, Cummin TE, Barrans S, Maishman T, Mamot C, Novak U, Caddy J, Stanton L, Kazmi-Stokes S, McMillan A, Fields P, Pocock C, Collins GP, Stephens R, Cucco F, Clipson A, Sha C, Tooze R, Care MA, Griffiths G, Du MQ, Westhead DR, Burton C, Johnson PWM. Gene-expression profiling of bortezomib added to standard chemoimmunotherapy for diffuse large B-cell lymphoma (REMoDL-B): an open-label, randomised, phase 3 trial. Lancet Oncol. 2019 May;20(5):649-662. doi: 10.1016/S1470-2045(18)30935-5. Epub 2019 Apr 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1.6 mg/m2 | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Comparator | Prednisolone | Other / unclassified | 100 mg | Oral |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Comparator | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |