A phase II trial of miltefosine in patients with cutaneous T-cell lymphoma.

A phase II trial evaluating 6% topical miltefosine solution was performed in 12 pretreated patients with cutaneous T-cell lymphoma. Miltefosine (Miltex) was administered for 8 weeks, once per day during the first week then twice every day for seven weeks. Main side effects consisted in moderate to mild pruritus or desquamation in 57 % and 50 % of patients, respectively. No systemic nor biological toxicity was observed. This treatment was administered on an outpatient basis exclusively. The overall response rate was 58 % with a median duration of response of 12 months. Miltefosine is a safe, simple and effective treatment in certain patients with cutaneous T-cell lymphoma.