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

  • End date
    Aug 25, 2024
  • participants needed
  • sponsor
    Stanford University
Updated on 25 April 2022
malignant disease
antibiotic therapy
monoclonal antibodies
immunosuppressive therapy
bone marrow procedure
gilbert's syndrome
progressive disease
neutrophil count
cancer therapy
t-cell lymphoma
sezary syndrome
renal function test
electron beam therapy
cutaneous t-cell lymphoma
total skin electron beam therapy
metastatic tumor
nitrogen mustard


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

Condition Sezary Syndrome, Mycosis Fungoides
Treatment Mogamulizumab, LD TSEBT
Clinical Study IdentifierNCT04256018
SponsorStanford University
Last Modified on25 April 2022


Yes No Not Sure

Inclusion Criteria

Stages 1B IV MF or SS
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
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
Adequate hematologic function
discussion with the Protocol Director
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)
Adequate hepatic function
Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3); or if known bone marrow involvement, then platelets ≥ 75,000 cells/μL (≥ 75,000/mm3)
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
Women of childbearing potential (WOCBP) must have a negative pregnancy test
graft vs host disease (GvHD) and receiving immunosuppressive therapy
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

Exclusion Criteria

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
weeks prior to study entry)
Pregnant or breastfeeding
allowed at ≤ 20 mg/day, if patient has been on a stable dose for at least 4
Active autoimmune disease or history deemed by the investigator to be clinically significant
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
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