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

Cutaneous T-Cell Lymphoma/Mycosis Fungoides Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06149247
• Other study ID #: HPN-CTCL-04
• Status: Recruiting
• Phase: Phase 2
• Start date: December 5, 2023
• Est. completion date: May 2024

Study information

• Verified date: December 2023
• Source: Soligenix
• Contact: Christopher Pullion, DO
• Phone: 609-538-8200
• Email: cpullion[@]soligenix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 completion of the treatment phase of the trial. Prior to randomization, each participant will have at least 3 and up to 5 lesions identified (index lesions) that will be evaluated during the treatment phase and during the follow-up visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous T-Cell Lymphoma/Mycosis Fungoides
• Lymphoma, T-Cell, Cutaneous
• Mycoses
• Mycosis Fungoides

Intervention

Drug:
• Hypericin
HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.
• Mechlorethamine Topical Gel
Valchlor is an FDA-approved drug for the treatment of CTCL.

Locations

Country	Name	City	State
United States	Rochester Skin Lymphoma Medical Group	Fairport	New York

Sponsors (1)

Lead Sponsor	Collaborator
Soligenix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score	A treatment response is defined as a =50% improvement in mCAILS score at Week 12 when compared to the mCAILS score at baseline.; The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm^2) to 18 (the lesion is larger than 300 cm^2). A lower score means a better outcome.	12 weeks