Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT05296304
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05296304
Study Brief:
Protocol Section:
NCT05296304