Final Report of a Phase 2 Clinical Trial of Lenalidomide Monotherapy for Patients With T-Cell Lymphoma

BACKGROUNDPatients with T-cell lymphomas face a poorer prognosis compared with patients with B-cell lymphomas. New therapeutic approaches need to be developed to improve outcomes for these patients. METHODSForty patients with recurrent and refractory T-cell lymphomas other than mycosis fungoides and patients with untreated T-cell lymphoma who were not candidates for combination chemotherapy were prescribed oral lenalidomide at a dose of 25 mg daily on days 1 to 21 of each 28-day cycle, with standardized dose reductions for toxicity. The primary endpoint was overall response rate (ORR), and secondary endpoints were complete and partial response rates, progression-free survival (PFS), overall survival (OS), and safety. The authors also determined duration of response (DoR). RESULTSA total of 40 patients were enrolled in the current study; 1 patient was subsequently deemed ineligible. The ORR was 10 of 39 patients (26%); 3 patients (8%) achieved complete responses and 7 patients achieved partial responses. Three patients had stable disease for 5 cycles. The median OS was 12 months (range <1 month to 69 months), the median PFS was 4 months (range, <1 month to 50 months), and the median DoR was 13 months (range 2 months to 37 months), including 5 responses that lasted >1 year. Toxicity was in keeping with the known safety profile of lenalidomide. Among the patients who had recurrent/refractory peripheral T-cell lymphoma (29 patients), the ORR was 24%, the median OS was 12 months, the median PFS was 4 months, and the median DoR was 5 months (range, 2 months to 37 months). CONCLUSIONSIn the current study, the use of oral lenalidomide monotherapy demonstrated clinically relevant efficacy among patients with systemic T-cell lymphomas. It appears to have excellent potential as an agent in combination therapy for patients with T-cell lymphoma. Cancer 2015;121:716-723. (c) 2014 American Cancer Society. Lenalidomide monotherapy demonstrates clinically relevant activity in patients with T-cell lymphoma and has a good safety profile. Lenalidomide has excellent potential as an agent in combination therapy for patients with T-cell lymphoma.