Cutaneous T-Cell Lymphoma/Mycosis Fungoides
Conditions
Keywords
CTCL, MF, Hypericin, HyBryte
Brief summary
The objective of this clinical study is to compare the safety and effectiveness of Valchlor versus HyBryte following 12 weeks of treatment.
Detailed 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.
Interventions
DRUGHypericin
HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.
DRUGMechlorethamine Topical Gel
Valchlor is an FDA-approved drug for the treatment of CTCL.
Sponsors
Soligenix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score | 12 weeks | 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. |
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 6 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 12 weeks. | 5 |
| Valchlor (Mechlorethamine) Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks. | 5 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | HyBryte (0.25 % Hypericin) | Valchlor (Mechlorethamine) | Total |
|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 19.18 | 62.4 years STANDARD_DEVIATION 13.48 | 59.3 years STANDARD_DEVIATION 16.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 2 / 5 | 3 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
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.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HyBryte (0.25 % Hypericin) | Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score | 3 Participants |
| Valchlor (Mechlorethamine) | Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score | 1 Participants |