Status:
COMPLETED
HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL
Lead Sponsor:
Soligenix
Conditions:
Cutaneous T-Cell Lymphoma/Mycosis Fungoides
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this clinical study is to compare the safety and effectiveness of Valchlor versus HyBryte following 12 weeks of treatment.
Detailed Description
Participants will be randomized to receive HyBryte or Valchlor in a 1:1 randomization. Participants will be treated for 12 weeks and follow-up visits will be conducted 1, 2, and 4 weeks after completi...
Eligibility Criteria
Inclusion
- Minimum of 3 active treatment-accessible CTCL lesions
- Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IA, IB, or Stage IIA
- Subjects willing to follow the clinical protocol and voluntarily give their written informed consent
- Female subjects not pregnant nor nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation
Exclusion
- History of severe allergic reaction to any of the components of HyBryte or mechlorethamine (Valchlor)
- Pregnancy or mothers who are breast-feeding
- All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception
- Subjects with history of sun hypersensitivity or photosensitive dermatoses (eg, porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.)
- Subjects whose condition is spontaneously improving
- Subjects receiving Valchlor (or any topical compound containing Mechlorethamine) in the preceding 2 months
- Subjects receiving topical steroids or other topical treatments (eg, targretin gel) on treatment accessible lesions for CTCL within 2 weeks of enrollment
- Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy (PUVA), narrow band ultraviolet B (UVB) light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment
- Subjects who have received electron beam irradiation within 3 months of enrollment
- Subjects with a history of significant systemic immunosuppression
- Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment
- Subject has any condition that, in the judgment of the Investigator, is likely to interfere with participation in the study
- Subjects receiving drugs known to cause photosensitization within 2 weeks of starting HyBryte therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06149247
Start Date
December 5 2023
End Date
June 27 2024
Last Update
August 20 2025
Active Locations (1)
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1
Rochester Skin Lymphoma Medical Group
Fairport, New York, United States, 14450