RecruitingPhase 2NCT04256018

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

A Phase 2 Single Center, Single Arm, Open Label Mogamulizumab Combined Upfront With Low Dose Total Skin Electron Beam Therapy (LD TSEBT) in Patients With Mycosis Fungoides (MF) and Sézary Syndrome (SS)


Sponsor

Stanford University

Enrollment

30 participants

Start Date

Mar 30, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is combining two treatments — a drug called mogamulizumab (which targets certain immune cells) and low-dose radiation to the whole skin (called total skin electron beam therapy) — for patients with a type of skin lymphoma called mycosis fungoides or Sézary syndrome, to see if the combination works better than either alone. **You may be eligible if:** - You have stage IB–IV mycosis fungoides or Sézary syndrome - You have had at least one prior standard treatment - You are 18 or older and able to carry out light daily activities - Side effects from prior treatments have mostly resolved **You may NOT be eligible if:** - You stopped a prior treatment due to serious side effects from that exact treatment - You have unresolved significant side effects from prior cancer treatments - Your disease was actively progressing while on mogamulizumab or the skin radiation previously Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMogamulizumab

Administered 1 mg/kg as an intravenous infusion over at least 60 minutes on Days 1, 8, 15, and 22 of the first 28 day cycle and on Days 1 and 15 of each subsequent cycle.

RADIATIONLD TSEBT

Patients will receive total skin dose of 12 Gy fractionated at 4 to 6 Gy per week, for 2-3 weeks


Locations(1)

Stanford Cancer Center

Stanford, California, United States

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NCT04256018


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