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Topical Duvelisib for Early-Stage Mycosis Fungoides

This study is looking into the safety and early effectiveness of a topical gel called duvelisib for people with early-stage mycosis fungoides (a type of cutaneous T-cell lymphoma). You may be able to join if you are 18 or older and have been diagnosed with Stage IA, IB, or IIA mycosis fungoides, with 3 to 5 active lesions that can be treated. The study aims to find out how many participants experience side effects, observe any skin reactions to the gel, and determine the highest safe dose of duvelisib topical gel. The study plans to enroll 30 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 30 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety endpoints, such as adverse events and local skin reactions, are measured up to Day 114. The maximum tolerated dose is measured for up to 28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07714187

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

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
SecuraBio
~30 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Duvelisib

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured over Baseline through Day 114
+3 more outcomes measured

Conditions

Mycosis Fungoides
Cutaneous T-cell Lymphoma

Explore related trials

Mycosis Fungoides

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Reuven Chantre, MD · STUDY_DIRECTOR · Secura Bio, Inc.

Who to contact

Medical Director
[email protected]
1-858-251-1414
Email the study team

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Eligibility criteria

Inclusion

Have a clinical diagnosis of Stage IA, Stage IB, or Stage IIA mycosis fungoides (cutaneous T-cell lymphoma), without clinically significant lymphadenopathy (≥1.5 centimeters).
Have 3 to 5 active, treatment-accessible mycosis fungoides lesions; ulcerated lesions and lesions to the face, neck, inguinal folds and intergluteal cleft are not considered suitable for administration of study drug.
Have baseline organ function (without transfusion support within 30 days of Cycle 1 Day 1) as defined by the protocol.

Exclusion

Have Stage IIB to IVB mycosis fungoides or Sezary syndrome.
Have histopathologically confirmed lymph node involvement.
Received systemic treatment with a phosphoinositide 3-kinases inhibitor in the 60 days prior to starting study drug.
Received topical steroids or other topical treatment (for example, nitrogen mustard) on mycosis fungoides lesions in the 2 weeks prior to starting study drug. Participants who receive such agents may become eligible for the study after a 14-day washout period.
Received systemic steroids, immunosuppressants (for example, cyclosporine, prednisone), psoralen ultraviolet A radiation therapy, narrow-band ultraviolet B light therapy, carmustine or other systemic therapies for mycosis fungoides in the 3 weeks prior to starting study drug.
Received electron beam irradiation within the 3 months prior to starting study drug.

What this trial measures

  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)Baseline through Day 114
  • Local Skin Reactions to Duvelisib Topical GelAfter each treatment administration up to Day 114

    Local skin reactions will be measured as a local skin reaction score using a four-point post-treatment assessment severity scale.

  • Maximum Tolerated Dose (MTD) of Duvelisib Topical GelUp to 28 days
  • Recommended Phase 2 Dose (RP2D) of Duvelisib Topical GelUp to 28 days