A Phase 1 Dose-escalation Study of Topical Duvelisib in Patients With Early-stage Mycosis Fungoides
SecuraBio
Summary
This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugDuvelisib
Topical gel
Location
- Johns Hopkins UniversityBaltimore, Maryland