Cutaneous T-Cell Lymphoma/Mycosis Fungoides
Conditions
Keywords
CTCL, MF, Hypericin, HyBryte
Brief summary
To assess the blood levels of hypericin and any electrocardiogram (ECG) changes during 8 weeks of HyBryte (topical hypericin ointment) photodynamic therapy.
Interventions
DRUGHypericin
HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.
Sponsors
Soligenix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IB or Stage IIA * CTCL lesions covering ≥ 10% of their body surface area
Exclusion criteria
* History of allergy or hypersensitivity to any of the components of HyBryte * Pregnancy or mothers who are breast-feeding * Males and females not willing to use effective contraception * Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g., porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.) * Subjects whose condition is spontaneously improving * Subjects receiving topical steroids or other topical treatments (e.g., nitrogen mustard) on index 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electrocardiograms (ECG) | 10 weeks | Assess any ECG QT interval changes (defined as any occurrences of QT interval \>500 ms or changes in QT interval \>60 ms) during standard HyBryte photodynamic therapy. |
| Systemic Blood Levels | 10 weeks | Assess the systemic blood levels of hypericin during standard HyBryte photodynamic therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 10 weeks | A treatment response was defined as a ≥50% improvement in CAILS score at Week 10 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. |
| Number of Index Lesions With a Treatment Response as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score. | 10 weeks | A treatment response was defined as a ≥50% improvement in CAILS score at Week 10 when compared to the CAILS score at baseline in each of the individual Index Lesions. 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. |
| Number of Index Lesions With a Complete Response as Defined as a 100% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score. | 10 weeks | A complete response was defined as a 100% improvement in CAILS score (a CAILS score of 0) at Week 10 in each of the individual Index Lesions. 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HyBryte (0.25 % Hypericin) HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 5 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 8 weeks.
Hypericin: HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | HyBryte (0.25 % Hypericin) |
|---|---|
| Age, Continuous | 62.0 years STANDARD_DEVIATION 7.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 3 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Electrocardiograms (ECG)
Assess any ECG QT interval changes (defined as any occurrences of QT interval \>500 ms or changes in QT interval \>60 ms) during standard HyBryte photodynamic therapy.
Time frame: 10 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HyBryte (0.25 % Hypericin) | Electrocardiograms (ECG) | 0 Participants |
Primary
Systemic Blood Levels
Assess the systemic blood levels of hypericin during standard HyBryte photodynamic therapy.
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HyBryte (0.25 % Hypericin) | Systemic Blood Levels | 0.00013 ug/mL | Standard Deviation 0.00011 |
Secondary
Number of Index Lesions With a Complete Response as Defined as a 100% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.
A complete response was defined as a 100% improvement in CAILS score (a CAILS score of 0) at Week 10 in each of the individual Index Lesions. 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.
Time frame: 10 weeks
Population: Each participant had 3 Index Lesions treated and evaluated
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| HyBryte (0.25 % Hypericin) | Number of Index Lesions With a Complete Response as Defined as a 100% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score. | Responder | 4 Index Lesions |
| HyBryte (0.25 % Hypericin) | Number of Index Lesions With a Complete Response as Defined as a 100% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score. | Non-Responder | 23 Index Lesions |
Secondary
Number of Index Lesions With a Treatment Response as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.
A treatment response was defined as a ≥50% improvement in CAILS score at Week 10 when compared to the CAILS score at baseline in each of the individual Index Lesions. 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.
Time frame: 10 weeks
Population: Each participant had 3 Index Lesions treated and evaluated
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| HyBryte (0.25 % Hypericin) | Number of Index Lesions With a Treatment Response as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score. | Responder | 7 Index Lesions |
| HyBryte (0.25 % Hypericin) | Number of Index Lesions With a Treatment Response as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score. | Non-Responder | 20 Index Lesions |
Secondary
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.
A treatment response was defined as a ≥50% improvement in CAILS score at Week 10 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.
Time frame: 10 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HyBryte (0.25 % Hypericin) | 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. | Responder | 2 Participants |
| HyBryte (0.25 % Hypericin) | 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. | Non-Responder | 7 Participants |