Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05296304

A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-04

20

Participants Needed

3

Research Sites

258 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The researchers are doing this study to test the safety of combining bexarotene with TSEB radiotherapy in people who have a common form of CTCL called mycosis fungoides (MF). Bexarotene is a form of vitamin A that activates proteins called retinoid X receptors, which may stop the growth of cancer cells and kill them. TSEB radiotherapy is a type of radiation therapy that treats the entire surface of the skin with very low doses of radiation to kill cancer cells and shrink tumors. This type of radiation does not pass through the outer layers of the skin into the tissues and organs below the skin. The study researchers think that giving bexarotene treatment at the same time as treatment with TSEB radiotherapy may be more effective against MF than either treatment given alone or in sequence (one after the other).

CONDITIONS

Official Title

A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 18 years
  • Pathologically confirmed cutaneous T-cell lymphoma consistent with mycosis fungoides (MF) based on biopsy done or reviewed at MSKCC
  • Stage IB or higher MF per ISCL/EORTC criteria; concurrent diagnosis of S�e9zary syndrome permissible
  • Patients who have not had prior systemic therapies and refractory/relapsed patients are eligible
  • Baseline mSWAT score of at least 10
  • Stable topical steroids or systemic antipruritic agent (e.g. antihistamines, doxepin, GABA analogs) preceding study entry is permissible
  • No new prescribed or over the counter topical or systemic anti-pruritics started post-enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Any oral retinoid therapy for any indication within 3 weeks of the first dose of study drug
  • Prior TSEB (prior focal skin-directed RT acceptable)
  • Concurrent diagnosis of systemic anaplastic large cell lymphoma (ALCL) or another non-Hodgkin lymphoma
  • Concurrent diagnosis of additional non-skin malignancy
  • Pregnancy
  • Patients unwilling to use two forms of barrier contraception while taking study medication
  • Receipt of treatment with another investigational device or drug (at present or within 2 weeks of enrollment)
  • Familial hypertriglyceridemia or other medical conditions in which use of bexarotene would be contraindicated
  • High likelihood of protocol non-compliance (in opinion of investigator)
  • Systemic steroids within two weeks of first dose of study drug (patients on systemic steroids for non-disease related conditions will be permitted per investigator discretion)
  • Use of gemfibrozil
  • Avoid strong/moderate CYP3A4 inducers and inhibitors if possible
  • Avoid concurrent administration with CYP3A4 sensitive substrates if possible

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

2

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

3

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States, 11553

Actively Recruiting

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Research Team

B

Brandon Imber, MD, MS

CONTACT

S

Shamir Geller

CONTACT

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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