Efficacy And Safety Of Mechlorethamine (Mch) 0.04% Gel In Mycosis Fungoides (Mf) After Treatment With Topical Mch 0.02%.

9093 Background: MF, the most common form of cutaneous T-cell lymphoma, is characterized by infiltration of the skin by malignant T cells and can further progress to other organs. Early stage disease (limited/localized skin involvement) is managed with skin-directed therapies. The first FDA approved topical formulation of MCH, MCH 0.02% gel (equivalent to 0.016% w/w MCH, mechlorethamine) was noninferior to MCH-Aquaphor (AP) 0.02% in a 12 mo study (Study 201). In clinical practice, patients (pts) who tolerate MCH 0.02% without complete response (CR) may have their dose increased to maximize response. Study 202 tested the efficacy and safety of MCH 0.04% gel after MCH 0.02%. Methods: Pts eligible for this 7 mo phase 2 extension study completed 12 mos of treatment with MCH 0.02% gel or AP without CR. All pts applied a thin layer of MCH 0.04% gel once daily. Application frequency could be reduced for toxicity. Primary endpoint was response rate defined as ≥ 50% improvement in composite assessment of index les...