Recruiting
Phase 1

Bexarotene & Radiotherapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05296304

Conditions

Cutaneous T-cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bexarotene

Total Skin Electron Beam (TSEB)

Study Details

Brief summary:

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

Cutaneous T-cell Lymphoma

Study ID

NCT05296304

Start date

Mar 16, 2022

Status verified date

Feb, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥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 Sézary 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, but 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

Exclusion Criteria:

  • 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)

Prohibited concurrent medications

  • Gemfibrozil is contraindicated as may increase bexarotene concentrations
  • Bexarotene is a minor CYP3A4 substrate: avoid strong/moderate CYP3A4 inducers and inhibitors, if possible, but concomitant use is not a contraindication Bexarotene is a moderate CYP3A4 inducer: avoid concurrent administration with CYP3A4 sensitive substrates, for which minimal concentration changes may lead to therapeutic failures of the substrate (e.g. cyclosporine, tacrolimus, sirolimus, quinidine, fentanyl), if possible

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bexarotene Combined With Radiotherapy

Patients will be initiated on bexarotene 150 mg daily on Day 1, with dose increase to 300 mg daily on Day 15. Patients will receive Cycle 1 of TSEB on Day 22 (with 2 Gy given on two consecutive days -Day 22 and 23), with safety assessment on Day 52. Efficacy will first be assessed on Day 52 and then again on Day 82 by global response assessment, including mSWAT. Patients who have less than 70% reduction from baseline mSWAT score will be eligible for subsequent cycles of TSEB (administered as 4 Gy over 2 consecutive days), until mSWAT score reduction of ≥ 70%, and up to a total of 6 cycles. Treatment may continue until disease progression, unacceptable toxicity, recommended termination by treating physician, or termination of the study.

Interventions

Bexarotene

Orally every day starting at the dose of 150 mg/day flat dose. At Day 15, if the treatment is tolerated, patients will escalate the dose of bexarotene to 300 mg/day, and that dose will remain constant during the rest of the study.

Total Skin Electron Beam (TSEB)

At Day 21, if the bexarotene has shown to be tolerated, patients will receive the first dose of TSEB (2 Gy x 2).

Primary outcome measure

  • Incidence of radiation dermatitis grade 3+ [ Time Frame: 1 month post-treatment ]

Central Contacts and Locations

Central contacts

Brandon Imber, MD, MS

631-212-6346imberb@mskcc.org

Shamir Geller

gellers@mskcc.org

Locations

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Brandon Imber, MD

631-212-6346

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Brandon Imber, MD

631-212-6346

Shamir Geller

gellers@mskcc.org

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Brandon Imber, MD

631-212-6346

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

  • Bexarotene
  • Radiotherapy
  • Mycosis Fungoides
  • 21-501

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-02-04.