HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this clinical study is to compare the safety and effectiveness of Valchlor versus HyBryte following 12 weeks of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Soligenix
• Treatments: Hypericin; Mechlorethamine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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