FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

Cutaneous T-Cell Lymphoma Clinical Trial

Official title:

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02448381
• Other study ID #: HPN-CTCL-01
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: November 2020

Study information

• Verified date: March 2022
• Source: Soligenix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: November 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must have a clinical diagnosis of CTCL (mycosis fungoides), Stage IA, Stage IB, or Stage IIA.

• Subjects must have a minimum of three (3) evaluable, discrete lesions.

• Subjects must be willing to refrain from sunbathing for the duration of the study.

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.

• Pregnancy or mothers who are breast feeding.

• Males and females not willing to use effective contraception.

• Unhealed sunburn.

• Subjects receiving topical steroids or other topical treatments for CTCL within 2 weeks.

• Subjects receiving systemic steroids, nitrogen mustard, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment.

• Subjects with significant history of systemic immunosuppression due to drugs or infection with HIV or HTLV 1.

• Subjects taking other investigational drugs or drugs of abuse within 30 days of entry into this study.

Related Conditions & MeSH terms

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

Intervention

Drug:
• SGX301 (synthetic hypericin)
0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.
• Placebo
USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Rush University	Chicago	Illinois
United States	Olympian Clinical Research	Clearwater	Florida
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	INOVA Schar Cancer Institute	Fairfax	Virginia
United States	Rochester Skin Lymphoma Medical Group	Fairport	New York
United States	MD Anderson	Houston	Texas
United States	Dawes Fretzin Dermatology Group	Indianapolis	Indiana
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Arkansas	Little Rock	Arkansas
United States	Leon Medical Research	Miami	Florida
United States	Medical Professional Clinical Research	Miami	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee
United States	Tulane University	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Stanford University	Palo Alto	California
United States	Austin Institute for Clinical Research	Pflugerville	Texas
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Jefferson Dermatology	Philadelphia	Pennsylvania
United States	University of Arizona	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	Therapeutics Clinical Research	San Diego	California
United States	Mayo Clinic	Scottsdale	Arizona
United States	Seattle Care Cancer Center	Seattle	Washington
United States	Stony Brook Medicine	Stony Brook	New York
United States	University of South Florida	Tampa	Florida
United States	PMG Research of Wilmington	Wilmington	North Carolina

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 Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a =50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score When Compared to Patients Receiving Placebo	The percentage of patients achieving a treatment response in each of the 2 treatment groups. A treatment response was defined as a =50% improvement in CAILS score at Week 8 when compared to the CAILS score at baseline.; The Composite Assessment of Index Lesion Disease Severity (CAILS) 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.; The overall CAILS score was calculated by adding the total score as described above for each of the 3 lesions. The overall CAILS score has a range of 0 to 111. A lower score means a better outcome.	8 weeks
Secondary	Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score (Cycle 1 and 2 SGX301 vs Cycle 1 Placebo)	The percentage of patients achieving a treatment response at Week 16 that received SGX301 for both Cycle 1 and 2 compared to the response rate in patients that received Placebo in Cycle 1.; The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.	16 weeks
Secondary	Number of Responders and Non-Responders With a Treatment Response of 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score in Patients Who Received 3 Cycles of SGX301	The percentage of patients achieving a treatment response at Week 24 compared at Week 16 in SGX301 treatment group. A treatment response was defined as a =50% improvement in CAILS score when compared to the CAILS score at baseline.; The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.	24 weeks
Secondary	Patch Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo)	The proportion of patch lesions achieving a treatment response at Week 16 in the SGX301 treatment group compared to Week 8 in the Placebo treatment group. A treatment response was defined as a =50% improvement in CAILS score when compared to the CAILS score at baseline for individual lesions.; The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.	16 weeks
Secondary	Plaque Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo)	The proportion of plaque lesions achieving a treatment response at Week 16 in the SGX301 treatment group compared to Week 8 in the Placebo treatment group. A treatment response was defined as a =50% improvement in CAILS score when compared to the CAILS score at baseline for individual lesions.; The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.	16 weeks

External Links

•   The Cutaneous Lymphoma Foundation
•   The National Organization for Rare Disorders