The purpose of this study is to determine the efficacy of the combination of LD-TSEBT and
mogamulizumab in patients with MF and SS. And to evaluate the secondary measures of clinical
benefit of the combination therapy and to evaluate the safety and tolerability of the
combination in patients with MF and SS.
Primary Objective:To determine the efficacy of the combination of LD TSEBT and mogamulizumab
in patients with MF and SS
Secondary Objective: To evaluate the secondary measures of clinical benefit of the
combination therapy and to evaluate the safety and tolerability of the combination in
patients with MF and SS
- Stages 1B IV MF or SS
- 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
- The Eastern Cooperative Oncology Group (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, if applicable.
- ≥ 4 weeks for retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or
other systemic anti cancer/cutaneous T-cell lymphoma (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
- ≥ 4 weeks for monoclonal antibodies; except > 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) ≥ 1,500 cells/μL (≥ 1,500/mm3); or if known bone
marrow involvement, then ANC ≥ 1,000 cells/μL (≥ 1,000/mm3)
- Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3); or if known bone marrow
involvement, then 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
- Serum creatinine ≤ 1.5 x ULN; or
- Calculated creatinine clearance > 50 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.
- MF with limited disease (Stage IA) or central nervous system (CNS) disease
- Current evidence of large cell transformed disease
_ Concomitant corticosteroid use. (Topical steroid and oral prednisone are allowed at
≤ 20 mg/day, if patient has been on a stable dose for at least 4 weeks prior to study
- Pregnant or breastfeeding
- Active autoimmune disease or history deemed by the investigator to be clinically
- Known human immunodeficiency virus (HIV) positivity; known human T cell lymphotropic
virus (HTLV 1) infection; or active hepatitis B or C.
- Active herpes simplex or herpes zoster. Those receiving prophylaxis for herpes and who
started taking medication at least 30 days prior to the Screening Visit, and have no
active signs of active infection, and whose last active infection was more than 6
months ago, may enter the study, and should continue to take the prescribed medication
for the duration of the study.