Study of Lenalidomide (Revlimid) in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL) Patients

Phase 2 Terminated 9 enrolled University of Bologna

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Revlimid is a potent immunomodulatory analogue without the teratogenic effects, which has direct anti-tumor effects, anti-angiogenic and both anti-inflammatory and T-cell costimulatory properties. Both preclinical and clinical data indicate its efficacy solid tumor and multiple myeloma including advanced/refractory stages with its role in enhancing host antitumor immunity that provided the rationale to use in patients with PTCL.

Timeline

Start: 2008-11
Primary completion: 2009-08
Completion: 2011-08

Outcome

Outcome not reported

Stopped: “The EC withdrawn the approval becuase of possible conflicts of interests between our Institute and Supporter (Celgene)”

Publications

Zinzani PL, Pellegrini C, Broccoli A, Stefoni V, Gandolfi L, Quirini F, Argnani L, Berti E, Derenzini E, Pileri S, Baccarani M. Lenalidomide monotherapy for relapsed/refractory peripheral T-cell lymphoma not otherwise specified. Leuk Lymphoma. 2011 Aug;52(8):1585-8. doi: 10.3109/10428194.2011.573031. Epub 2011 Apr 19. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenalidomide	Other / unclassified	25 mg	Oral