Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome

Inclusion Criteria27

• Stages IB-IV MF or SS
• Stages IB-IV MF or SS
• At least 1 prior standard-of-care therapy
• Prior LD-TSEBT (\> 3 months prior) and prior mogamulizumab is allowed, as long as progressive disease (PD) did not occur while on therapy, and did not discontinue due to toxicities
• ≥ 18 years of age
• ECOG performance status of 0 to 2
• All clinically-significant toxic effects of prior cancer therapy resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE, v 5.0).
• MF and a known history of non-complicated staphylococcus colonization/infection is eligible provided that stable doses of prophylactic antibiotics continue.
• The following minimum wash-out from previous treatments are required (prior to 1st day of treatment), if applicable.
• • ≥ 2weeks for retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or other systemic anti-cancer/CTCL therapies
• • ≥ 2 weeks for phototherapy, local radiation therapy
• • ≥ 2 weeks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod)
• • ≥ 12 weeks for total skin electron beam therapy
• • \> 12 weeks for alemtuzumab
• • Rapidly progressive malignant disease may be enrolled prior to above periods after discussion with the Protocol Director.
• Adequate hematologic function
• • Absolute neutrophil count (ANC) ≥ 1,000 cells/μL (≥ 1,000/mm3)
• • Platelets ≥ 75,000 cells/μL (≥ 75,000/mm3).
• Adequate hepatic function
• Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN). Exception: If Gilbert's syndrome; then ≤ 5 times ULN.
• Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN; or ≤ 5.0 x ULN in the presence of known hepatic involvement by CTCL.
• Adequate renal function
• • Calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula.
• If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of graft-vs-host disease (GvHD) and receiving immunosuppressive therapy.
• Women of childbearing potential (WOCBP) must have a negative pregnancy test.
• WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.
• Male participants and their female partners of child bearing potential must be willing to use an appropriate method of contraception during the study and for 3 months after the last dose.