Actively Recruiting
Mogamulizumab Combined With Low Dose Total Skin Electron Beam Therapy for Mycosis Fungoides and S e9zary Syndrome Patients
Led by Stanford University · Updated on 2025-07-02
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how well the combination of low-dose total skin electron beam therapy (LD-TSEBT) and the drug mogamulizumab works in patients with Mycosis Fungoides (MF) and S e9zary Syndrome (SS). It also assesses the clinical benefits, safety, and tolerability of this combined treatment in these patients. The study is a Phase 2, open-label trial conducted at a single center. Participants receive mogamulizumab intravenously at 1 mg/kg on Days 1, 8, 15, and 22 during the first 28-day cycle, then on Days 1 and 15 of subsequent cycles. LD-TSEBT delivers a total skin dose of 12 Gy, fractionated over 2 to 3 weeks, starting on Cycle 1 Day 2. Treatment follows standard care guidelines and is adjusted based on patient tolerance. During the study, participants undergo regular assessments to measure overall response rate at 12 months, along with secondary evaluations including time to next significant treatment, progression-free survival, duration of response, quality of life, and treatment-related adverse events. Researchers monitor safety and clinical benefits over up to three years. The total participation time varies based on individual treatment and follow-up schedules.
CONDITIONS
Brief Title
Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with stages IB-IV Mycosis Fungoides or S�e9zary Syndrome
- At least 18 years of age
- Received at least one prior standard-of-care therapy
- Prior low-dose total skin electron beam therapy and mogamulizumab allowed if no disease progression or toxicity-related discontinuation
- ECOG performance status between 0 and 2
- All significant toxic effects from prior cancer treatments resolved to Grade 21
- Stable prophylactic antibiotics allowed for non-complicated staphylococcus colonization/infection
- Required wash-out periods from previous treatments before starting study therapy
- Adequate blood, liver, and kidney function
- If prior allogeneic hematopoietic stem cell transplant, free of graft-versus-host disease and on immunosuppressive therapy
- Women of childbearing potential must have negative pregnancy test and agree to contraception during and 3 months after treatment
- Male participants and female partners must use contraception during and 3 months after treatment
You will not qualify if you...
- Diagnosed with limited disease (Stage IA) or central nervous system involvement
- Concurrent corticosteroid use above specified limits
- Pregnant or breastfeeding
- Active autoimmune disease or clinically significant history
- Known HIV infection or active hepatitis B or C
- Active herpes simplex or herpes zoster infections unless controlled with prophylactic medication started at least 30 days prior and stable for 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive mogamulizumab infusions and low-dose total skin electron beam therapy as part of the combination treatment.
Infusions on Days 1, 8, 15, and 22 of the first cycle; Days 1 and 15 of subsequent cycles; LD TSEBT over 2 to 3 weeks starting Cycle 1 Day 2
Trial Site Locations
Total: 1 location
1
Stanford Cancer Center
Stanford, California, United States, 94304
Actively Recruiting
Research Team
Z
Zainab Ahmed
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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