Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides
Trial Parameters
Brief Summary
This is an open label, single center, non-randomized dose de-escalation phase I study of combination of BV and Mogamulizumab. The primary objective of the study is to assess the safety and tolerability of the combination. The primary objective is also to explore safe dose of combination for future expansion.
Eligibility Criteria
Inclusion Criteria: 1. Able to understand and comply with study procedure, understand the risks involved in the study and provide written informed consent before the first study-specific procedure 2. Men or women \>18 years with pathologically confirmed diagnosis of Sezary Syndrome or Mycosis fungoides 3. Must have CD30 positivity on recent biopsy of \>1% 4. Stage II-IV, for skin only disease \>20% BSA should be involved, large cell transformation is allowed. 5. Must have received at least one prior systemic therapy like bexarotene, interferons, ECP, methotrexate, Gemcitabine, Vorinostat etc. (patients who have received only skin directed therapy are not allowed) 6. ECOG performance status of 0,1 or 2 7. Adequate organ function at screening defined as follows * Hepatic: T bili \<2 X ULN, isolated bilirubin of \>2 is accepted if there is suspected diagnosis of Gilbert's syndrome, AST and ALT \<3X ULN * Renal: estimated GFR \>40 mL/Min/1.73 m2 * Cardiac: LVEF \>40% 8. Patients must have