drugset / Trial / NCT01197560
Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.
Timeline
- Start
- 2010-09-02
- Primary completion
- 2013-07-04
- Completion
- 2018-04-05
Publications
- Results Czuczman MS, Trneny M, Davies A, Rule S, Linton KM, Wagner-Johnston N, Gascoyne RD, Slack GW, Brousset P, Eberhard DA, Hernandez-Ilizaliturri FJ, Salles G, Witzig TE, Zinzani PL, Wright GW, Staudt LM, Yang Y, Williams PM, Lih CJ, Russo J, Thakurta A, Hagner P, Fustier P, Song D, Lewis ID. A Phase 2/3 Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Lenalidomide Versus Investigator's Choice in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma. Clin Cancer Res. 2017 Aug 1;23(15):4127-4137. doi: 10.1158/1078-0432.CCR-16-2818. Epub 2017 Apr 5.
- Hernandez-Ilizaliturri FJ, Deeb G, Zinzani PL, Pileri SA, Malik F, Macon WR, Goy A, Witzig TE, Czuczman MS. Higher response to lenalidomide in relapsed/refractory diffuse large B-cell lymphoma in nongerminal center B-cell-like than in germinal center B-cell-like phenotype. Cancer. 2011 Nov 15;117(22):5058-66. doi: 10.1002/cncr.26135. Epub 2011 Apr 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Etoposide | Small molecule | 50 mg/m2 | Intravenous |
| Comparator | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Subject | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 15 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Comparator | Oxaliplatin | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |