The first patient was recently registered into the newly initiated EORTC trial 21081, a phase III study designed to determine if maintenance treatment with lenalidomide (Revlimid™) prolongs progression free survival in chemonaive patients with advanced stage cutaneous T-cell lymphoma (CTCL).
Primary CTCLs are rare; they afflict roughly one to two persons per 100,000 in the general population. There are no defined standards of care for advanced stages of the disease, and because of its rarity, CTCLs have been the focus of very few randomized trials.
Treatment of CTCLs represented an unmet need, so the EORTC Headquarters Early Project Optimization Department (EPOD) together with the EORTC Cutaneous Lymphoma Task Force assembled an EORTC CTCL European Platform (link to CTCL platform newsletter article, June 2009). In addition to the 21081 trial, this platform includes a study designed to investigate whether a rational combination of treatment agents could overcome resistance or increase efficacy over monotherapies and a study being designed for advanced stage patients who have progressed on prior systemic chemotherapy.
The EORTC 21081 trial, the first study in this platform, was designed to see if maintenance treatment with lenalidomide could improve progression free survival. Previous studies have shown that CTCL usually recurs after a few months, and lenalidomide, used clinically in the treatment of some kinds of myelodysplastic syndrome and multiple myeloma, has shown promise in the treatment some types of lymphomas. In this trial patients will be randomized to two arms: one of the arms will receive the lenalidomide maintenance treatment, and the other arm, the observation arm, will not.
All patients entering this trial will have previously achieved complete or partial response after standardized debulking treatment with either gemcitabine or liposomal doxorubicin (or optionally with local low dose radiotherapy). The trial will accrue a target of 105 patients who are likely to respond to debulking treatment, and the two study arms will then be compared in terms of the difference in progression free survival. The study will be conducted in 25 centersin ten countries.
Dr. Martine Bagot of the Hôpital Saint-Louis (AP-HP) in Paris is the Study Coordinator for this trial.
Matthias Karrasch and John Bean