Romidepsin, a histone deacetylase inhibitor, and lenalidomide, an immunomodulatory agent, have previously shown efficacy and a lack of cumulative toxicity in the treatment of patients with relapsed/refractory lymphoma and myeloma. Results from phase I of this trial were previously reported in ASCO 2014. The maximum tolerated dose in cycle 1 for romidepsin was 14 mg/m2 IV on days 1, 8, and 15, while lenalidomide was 25 mg oral on days 1-21 of a 28-day cycle. In this trial patients were treated to progression or intolerance. Results of patients with t-cell lymphoma were reported at the 2015 ASCO meeting.
21 patients (10 CTCL, 11 PTCL) with a median age of 64 were enrolled in this trial. 15 of these patients were treated at the maximum tolerated dose. 19 of these patients were evaluable for efficacy with an overall response rate of 53%. For patients the median time of response was 7.3 weeks, median event free survival was 15.5 weeks, and median overall survival was not reached. 10 out of 21 patients remained on therapy with 7 discontinued for disease progression, 3 for toxicity, and 1 for stem cell transplant. Side effects were generally expected and manageable.
Results from this study confirm that the romidepsin and lenalidomide combination has significant activity in relapsed and refractory T-cell lymphoma. This study demonstrated that novel biologic agent and combinations can be effective and well-tolerated treatment options for patients with T-cell lymphoma, who may be poor candidates for intensive therapy or have chemotherapy-resistant disease.