drugset / Trial / NCT00875667
A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
RandomizedParallel-groupOpen-labelTreatment
Summary
To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma.
Timeline
- Start
- 2009-04-30
- Primary completion
- 2018-06-28
- Completion
- 2018-10-09
Publications
- Background Trneny M, Lamy T, Walewski J, Belada D, Mayer J, Radford J, Jurczak W, Morschhauser F, Alexeeva J, Rule S, Afanasyev B, Kaplanov K, Thyss A, Kuzmin A, Voloshin S, Kuliczkowski K, Giza A, Milpied N, Stelitano C, Marks R, Trumper L, Biyukov T, Patturajan M, Bravo MC, Arcaini L; SPRINT trial investigators and in collaboration with the European Mantle Cell Lymphoma Network. Lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma (MCL-002; SPRINT): a phase 2, randomised, multicentre trial. Lancet Oncol. 2016 Mar;17(3):319-331. doi: 10.1016/S1470-2045(15)00559-8. Epub 2016 Feb 16.
- Hagner PR, Chiu H, Ortiz M, Apollonio B, Wang M, Couto S, Waldman MF, Flynt E, Ramsay AG, Trotter M, Gandhi AK, Chopra R, Thakurta A. Activity of lenalidomide in mantle cell lymphoma can be explained by NK cell-mediated cytotoxicity. Br J Haematol. 2017 Nov;179(3):399-409. doi: 10.1111/bjh.14866. Epub 2017 Aug 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Chlorambucil | Other / unclassified | — | — |
| Comparator | Cytarabine | Small molecule | — | — |
| Comparator | Fludarabine | Small molecule | — | — |
| Comparator | Gemcitabine | Small molecule | — | — |
| Subject | Lenalidomide | Other / unclassified | 15 mg | — |
| Subject | Lenalidomide | Other / unclassified | 25 mg | — |
| Comparator | Rituximab | Monoclonal antibody | — | — |