Topical treatment for cutaneous T-cell lymphoma using HyBryte
A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte™ (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
This study is testing if a new gel called HyBryte can help people with a type of skin cancer called cutaneous T-cell lymphoma feel better when used with light treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Soligenix Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 17 sites (Phoenix, Arizona and 16 other locations) |
| Trial ID | NCT06470451 on ClinicalTrials.gov |
What this trial studies
This Phase 3 study evaluates the effectiveness of HyBryte, a topical photosensitizing agent, in treating patients with patch/plaque phase cutaneous T-cell lymphoma (CTCL). Participants will apply either HyBryte gel or a placebo gel twice weekly for 18 weeks, followed by exposure to visible light. The study aims to compare treatment responses between the HyBryte and placebo groups, with a focus on safety and efficacy. Patients will be monitored for treatment response and safety over a total of 12 weeks after the last light session.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with Stage IA, IB, or IIA cutaneous T-cell lymphoma who have at least three evaluable lesions.
Not a fit: Patients with a history of sun hypersensitivity or certain photosensitive conditions may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from cutaneous T-cell lymphoma.
How similar studies have performed: Other studies using photosensitizing agents for similar conditions have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL), Stage IA, Stage IB, or Stage IIA. * Patients with a minimum of three (3) evaluable, discrete lesions. * Patients willing to follow the clinical protocol and voluntarily give their written informed consent. * Female patients not pregnant or nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation. Exclusion Criteria: * History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous light eruptions, or radiation therapy within 30 days of enrolling. * History of allergy or hypersensitivity to any of the components of HyBryte. * A Screening ECG with a QT interval \>470 ms (corrected for heart rate using the Fridericia's formula). * All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception. * Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment. * Patients receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 4 weeks of enrollment. * Patients who have received electron beam irradiation within 3 months of enrollment. * Patients with a history of significant systemic immunosuppression. * Patients taking other investigational drugs or drugs of abuse within 30 days of entry into this study. * Patients whose condition is spontaneously improving. * Patients with tumor stage or erythrodermic CTCL (stages IIB-IV). * Patients with extensive skin disease (\>30% body surface area) who would be, in the judgement of the Principal Investigator, candidates for systemic treatment. * Patient has any condition that, in the judgment of the PI, is likely to interfere with participation in the study. * Prior participation in the current study.
Where this trial is running
Phoenix, Arizona and 16 other locations
- Medical Dermatology Specialists — Phoenix, Arizona, United States (Completed)
- Mayo Clinic — Scottsdale, Arizona, United States (Recruiting)
- Therapeutics Clinical Research — San Diego, California, United States (Completed)
- University of South Florida — Tampa, Florida, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Dawes Fretzin Dermatology Group — Indianapolis, Indiana, United States (Recruiting)
- Washington University — St Louis, Missouri, United States (Recruiting)
- Rochester Skin Lymphoma Medical Group — Fairport, New York, United States (Recruiting)
- Columbia University Medical Center — New York, New York, United States (Completed)
- Accellacare (PMG) — Wilmington, North Carolina, United States (Completed)
- Penn State Health Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Vanderbilt University — Nashville, Tennessee, United States (Completed)
- MD Anderson — Houston, Texas, United States (Recruiting)
- Austin Institute for Clinical Research — Pflugerville, Texas, United States (Recruiting)
- Inova Schar Cancer Institute — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Jennifer Bonfrisco
- Email: jbonfrisco@soligenix.com
- Phone: 609-538-8200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.