Mogamulizumab and Low-Dose Radiation for Mycosis Fungoides and Sézary Syndrome

This study is testing a combination treatment for Mycosis Fungoides (MF) and Sézary Syndrome (SS), which are types of lymphoma affecting the skin. You would receive a drug called mogamulizumab through an IV, along with low-dose total skin electron beam therapy (LD-TSEBT), a type of radiation that treats the skin. The main goal is to see how many patients respond to this combined treatment after 12 months. Researchers also want to learn about the safety and other benefits of this combination. You may be able to join if you have Stage IB-IV MF or SS, have tried at least one other standard treatment, and are at least 18 years old. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
Mogamulizumab is given as an intravenous infusion on specific days during 28-day cycles. LD-TSEBT is given over 2-3 weeks, 4 to 6 Gy per week.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, overall response rate, is measured at 12 months.

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NCT04256018

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Stanford University
~30 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:MogamulizumabLD TSEBT

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR)
Measured over 12 months
Sezary Syndrome
Mycosis Fungoides

NCT04256018

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Stanford Cancer Center

    Stanford, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Youn H Kim, MD · PRINCIPAL_INVESTIGATOR · Stanford University

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Eligibility criteria

Inclusion

Stages IB-IV MF or SS
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. 11. Adequate renal function
  • Overall response rate (ORR)12 months

    Response to treatment will be assessed as the number and proportion of participants who achieve either a complete response (CR) or partial response (PR). The outcome is reported as numbers without dispersion. Clinical response will be assessed as follows. * CR: Complete disappearance of all clinical evidence of disease * PR: Decrease in size or amount of measurable disease lesions * Progressive disease (PD): Worsening of lesions; appearance of new lesions; or recurrence of lesions * Stable disease (SD): Disease status that is neither CR, PR, nor PD.