Clinical trial NCT02448381: FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cutaneous T-Cell Lymphoma
Keywords: CTCL
Mycosis fungoides
Hypericin
SGX301
MF
Lead sponsor: Soligenix
Sponsor class: INDUSTRY
First posted: 2015-05-19
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 8 weeks
Secondary outcomes:
measure: 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)
timeFrame: 16 weeks
measure: 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
timeFrame: 24 weeks
measure: Patch Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo)
timeFrame: 16 weeks
measure: Plaque Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Phoenix
country: United States
facility: University of Arizona
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Clearwater
country: United States
facility: Olympian Clinical Research
state: Florida
city: Miami
country: United States
facility: Leon Medical Research
state: Florida
city: Miami
country: United States
facility: Medical Professional Clinical Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Dermatology Group
state: Indiana
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Fairport
country: United States
facility: Rochester Skin Lymphoma Medical Group
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Dermatology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Fairfax
country: United States
facility: INOVA Schar Cancer Institute
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Seattle
country: United States
facility: Seattle Care Cancer Center
state: Washington
Study officials:
References:
citation: Kim EJ, Mangold AR, DeSimone JA, Wong HK, Seminario-Vidal L, Guitart J, Appel J, Geskin L, Lain E, Korman NJ, Zeitouni N, Nikbakht N, Dawes K, Akilov O, Carter J, Shinohara M, Kuzel TM, Piette W, Bhatia N, Musiek A, Pariser D, Kim YH, Elston D, Boh E, Duvic M, Huen A, Pacheco T, Zwerner JP, Lee ST, Girardi M, Querfeld C, Bohjanen K, Olsen E, Wood GS, Rumage A, Donini O, Haulenbeek A, Schaber CJ, Straube R, Pullion C, Rook AH, Poligone B. Efficacy and Safety of Topical Hypericin Photodynamic Therapy for Early-Stage Cutaneous T-Cell Lymphoma (Mycosis Fungoides): The FLASH Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2022 Sep 1;158(9):1031-1039. doi: 10.1001/jamadermatol.2022.2749.
citation: Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.