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Phase 1Not yet recruitingPriority 4 · Lower priorityNCT07714187

A Study of Topical Duvelisib in Participants With Early-stage Mycosis Fungoides

ClinicalTrials.gov

Plain-language summary

This trial is testing duvelisib (an oral PI3K inhibitor) for patients with cutaneous T-cell lymphoma (CTCL), including mycosis fungoides or Sézary syndrome at various stages of their disease. This is a Phase 1 trial, which means researchers are finding the right dose and this is among the earliest testing in patients. The study looks at both safety and how well the treatment controls the lymphoma. This trial is available at 1 location in the United States. The trial is not yet open for recruitment.

Who can join (key eligibility)

  • Age 18 Years or older
  • See full trial listing for complete eligibility

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

Duvelisib (DRUG): Topical gel

  • Duvelisib

Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

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TrialCompass — Clinical Trial Summary

A Study of Topical Duvelisib in Participants With Early-stage Mycosis Fungoides

NCT07714187

Phase: Phase 1 | Status: Not yet recruiting | Priority: Lower

Plain-language summary

This trial is testing duvelisib (an oral PI3K inhibitor) for patients with cutaneous T-cell lymphoma (CTCL), including mycosis fungoides or Sézary syndrome at various stages of their disease. This is a Phase 1 trial, which means researchers are finding the right dose and this is among the earliest testing in patients. The study looks at both safety and how well the treatment controls the lymphoma. This trial is available at 1 location in the United States. The trial is not yet open for recruitment.

Who can join

  • Age 18 Years or older
  • See full trial listing for complete eligibility

What's being tested

Duvelisib (DRUG): Topical gel

Drugs / treatments: Duvelisib

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 30 patients

Primary endpoint: Number of Participants with Treatment-emergent Adverse Events (TEAEs); Local Skin Reactions to Duvelisib Topical Gel; Maximum Tolerated Dose (MTD) of Duvelisib Topical Gel; Recommended Phase 2 Dose (RP2D) of Duvelisib Topical Gel

Ages: 18 Years to —

Start date: 2027-01 | Est. completion: 2029-01

Locations

1 US sites · 1 total

Maryland

Contact

Medical Director | TopicalStudy@securabio.com | 1-858-251-1414

Sponsor: SecuraBio (INDUSTRY)

Tags

CTCL · any

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT07714187

Prepared using TrialCompass (trialcompass.com) on August 2, 2026. For informational purposes only. Always discuss with your healthcare team.