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NCT07714187
A Study of Topical Duvelisib in Participants With Early-stage Mycosis Fungoides
Conditions: Mycosis Fungoides, Cutaneous T-cell Lymphoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 30
Sponsor: SecuraBio
Location: Johns Hopkins University Baltimore Maryland
Summary
This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.
Eligibility Criteria
Key Inclusion Criteria:
* 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.
Key Exclusion Criteria:
* 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.
Note: other protocol-defined criteria apply.
Source: ClinicalTrials.gov (NCT07714187). StuddyBuddy aggregates publicly available trial information.