Study on Mogamulizumab and Low-Dose Total Skin Electron Beam Therapy for Mycosis Fungoides and Sézary Syndrome

Inclusion Criteria

• Have Mycosis Fungoides or Sézary Syndrome at stages 1B to IV.
• Have tried at least one standard treatment before.
• Previous treatments with LD-TSEBT or mogamulizumab are allowed if the disease did not worsen during treatment and was not stopped due to side effects.
• Be 18 years or older.
• Have a performance status score of 0 to 2, indicating good overall health.
• Any significant side effects from previous cancer treatments must have improved to a mild level.
• Have a history of non-complicated staphylococcus infection, if stable on antibiotics.
• Meet specific time requirements since last treatments, such as:
  • At least 4 weeks since certain cancer therapies.
  • At least 2 weeks since phototherapy or local radiation.
  • At least 12 weeks since total skin electron beam therapy.
  • At least 4 weeks since monoclonal antibodies, except 12 weeks for alemtuzumab.
• Have adequate blood cell counts and organ function.
• Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 3 months after.
• Men and their female partners must agree to use contraception during the study and for 3 months after.

Exclusion Criteria

• Have limited Mycosis Fungoides (Stage IA) or central nervous system disease.
• Use corticosteroids, except for topical steroids or oral prednisone at 20 mg/day or less if stable for 4 weeks before the study.
• Be pregnant or breastfeeding.
• Have an active autoimmune disease or significant history of one.
• Have known HIV, HTLV-1, or active hepatitis B or C infections.
• Have active herpes infections, unless on preventive medication for at least 30 days before the study and no active infection for over 6 months.