EORTC trial 21011 was a randomized, open-label phase III trial evaluating the safety and efficacy of targretin capsules combined with psoralens in combination with ultraviolet light compared to psoralens in combination with ultraviolet light treatment alone in patients with stage IB-IIA cutaneous T-cell lymphoma (CTCL). The study was activated in October 2003 and included 94 of the required 145 patients. It was closed due to poor accrual in May 2010, and the final analysis was conducted in October 2011. An abstract was presented at ASCO 2012 (J Clin Oncol 2012; 30 [suppl; abstr 8076]) and the results were published (Brit J Dermatology 2012;167(3):678-687).
EORTC trial 21012 was a phase II clinical trial with caelyx mono-chemotherapy in patients with advanced Mycosis Fungoides stage IIb, IVa and IVb with or without previous chemotherapy. The results of this study were presented at ASH 2010 and the results were published (J Clin Oncol 2012;30(33):4091-4097).
EORTC trial 21081 was a phase III study of lenalidomide maintenance after debulking therapy in patients with advanced CTCL. This trial opened for recruitment in 2010. Due to the rarity of CTCL, very few randomized trials have been performed in this disease. The EORTC has published consensus recommendations for the treatment of mycosis fungoides/Sézary syndrome. Treatment of advanced stage disease is largely empirical, based on small non-randomized, uncontrolled studies with response data. Recently developed treatments include histone deacetylase inhibitors, proteosome inhibitors, and monoclonal antibodies. In patients with advanced stage disease, treatments frequently induce partial responses or complete responses with relapse after a few months, but the prognosis becomes increasingly poor with subsequent lines of therapy. This study concerned the ability of maintenance treatment with lenalidomide to prolong the response achieved by these debulking regimens. Patients were randomized to either receive the maintenance therapy or not.
The trial has been stopped earlier (Sept 2013) due to company decision and a descriptive analysis is now ongoing.