Confirmatory Study of Topical HyBryte™ Vs. Placebo for the Treatment of CTCL (FLASH2)

Overview

About this study

The purpose of this study is to evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL), Stage IA, Stage IB, or Stage IIA.
  • Patients with a minimum of three (3) evaluable, discrete lesions.
  • Patients willing to follow the clinical protocol and voluntarily give their written informed consent.
  • Female patients not pregnant or nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation.

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.
  • History of allergy or hypersensitivity to any of the components of HyBryte.
  • A Screening ECG with a QT interval >470 ms (corrected for heart rate using the Fridericia's formula).
  • All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception.
  • Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment.
  • Patients receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 4 weeks of enrollment.
  • Patients who have received electron beam irradiation within 3 months of enrollment.
  • Patients with a history of significant systemic immunosuppression.
  • Patients taking other investigational drugs or drugs of abuse within 30 days of entry into this study.
  • Patients whose condition is spontaneously improving.
  • Patients with tumor stage or erythrodermic CTCL (stages IIB-IV).
  • Patients with extensive skin disease (>30% body surface area) who would be, in the judgement of the Principal Investigator, candidates for systemic treatment.
  • Patient has any condition that, in the judgment of the PI, is likely to interfere with participation in the study.
  • Prior participation in the current study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/08/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Aaron Mangold, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20580626

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