Combination therapy aims to boost response in rare skin cancers
NCT ID NCT04256018
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This trial tests whether combining the drug mogamulizumab with low-dose total skin electron beam therapy works better than either alone for people with mycosis fungoides or Sezary syndrome, two rare types of skin lymphoma. Participants receive both treatments over several weeks. The study measures how many people's cancer shrinks or disappears, and how long that effect lasts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mogamulizumab and low-dose total skin electron beam therapy
- What this could lead to
- If successful, this combination could offer a more effective treatment option for people with advanced stages of mycosis fungoides and Sezary syndrome, potentially leading to better disease control.
- What could go wrong
- This is a small, early-phase study (30 participants) at a single center, so results may not apply broadly. The combination may cause side effects from both the drug and radiation, and it is not a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2020
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Stages IB-IV MF or SS 1. Stages IB-IV MF or SS 2. At least 1 prior standard-of-care therapy 3. 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 4. ≥ 18 years of age 5. ECOG performance status of 0 to 2 6. 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). 7. MF and a known history of non-complicated staphylococcus colonization/infection is eligible provided that stable doses of prophylactic antibiotics continue. 8. The following minimum wash-out from previous treatments are required (prior to 1st day of treatment), if applicable. • ≥ 2weeks for retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or other systemic anti-cancer/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 • \> 12 weeks for alemtuzumab • Rapidly progressive malignant disease may be enrolled prior to above periods after discussion with the Protocol Director. 9. Adequate hematologic function • Absolute neutrophil count (ANC) ≥ 1,000 cells/μL (≥ 1,000/mm3) • Platelets ≥ 75,000 cells/μL (≥ 75,000/mm3). 10. 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. 11. Adequate renal function • Calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula. 12. If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of graft-vs-host disease (GvHD) and receiving immunosuppressive therapy. 13. Women of childbearing potential (WOCBP) must have a negative pregnancy test. 14. WOCBP must agree to use effective contraception during the study and for 3 months after the last dose. 15. 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: <!-- --> 1. MF with limited disease (Stage IA) or central nervous system (CNS) disease 2. Concomitant corticosteroid use. (with the exception that topical steroid and oral prednisone are allowed at ≤ 20 mg/day, if patient has been on a stable dose for at least 2 weeks prior to 1st day of treatment) 3. Pregnant or breastfeeding 4. Active autoimmune disease or history deemed by the investigator to be clinically significant 5. Known human immunodeficiency virus (HIV) positivity; or active hepatitis B or C. 6. 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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stanford Cancer Center
RECRUITINGStanford, California, 94304, United States
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