A Study of Topical Duvelisib in Participants With Early-stage Mycosis Fungoides
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecuraBio
About this trial
This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Duvelisib
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov