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New treatment option for Cutaneous T-cell Lymphoma
Official title A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides
ClinicalTrials.gov ID: NCT05296304
What this study is testing
What is Bexarotene?
Bexarotene is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cutaneous t-cell lymphoma.
Also referred to as Targretin®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Ability to provide informed consent
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Commack, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Commack, New York, United States; New York, New York, United States; Rockville Centre, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.