Clinical trial · Interventional
HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL
Pilot Study of HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL
NCT06149247CI-TRIAL-00093873completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this clinical study is to compare the safety and effectiveness of Valchlor versus HyBryte following 12 weeks of treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous T-Cell Lymphoma/Mycosis Fungoides | Mycosis Fungoides | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypericin | Drug | — | UNRESOLVED |
| Mechlorethamine Topical Gel | Drug | Mechlorethamine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HyBryte (0.25 % hypericin)
- description
- 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.
- interventionNames
- Drug: Hypericin
- type
- ACTIVE_COMPARATOR
- label
- Valchlor (mechlorethamine)
- description
- Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks.
- interventionNames
- Drug: Mechlorethamine Topical Gel
Primary outcomes (1)
- measure
- Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPoligone B, Pullion C, Rumage A, Straube R, Donini O, Schaber CJ, Gilmore ES. Results from a Pilot Study of HyBryte (Topical Synthetic Hypericin) Versus Valchlor(R) (Mechlorethamine) in the Treatment of CTCL. Oncol Ther. 2026 Jun;14(2):693-705. doi: 10.1007/s40487-026-00430-1. Epub 2026 Apr 1. PMID 41920467