Clinical trial · Interventional
A Study of Topical Duvelisib in Participants With Early-stage Mycosis Fungoides
A Phase 1 Dose-escalation Study of Topical Duvelisib in Patients With Early-stage Mycosis Fungoides
NCT07714187CI-TRIAL-00118604not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous T-cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duvelisib | Drug | Duvelisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Duvelisib
- interventionNames
- Drug: Duvelisib
Primary outcomes (4)
- measure
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)
- timeFrame
- Baseline through Day 114
- measure
- Local Skin Reactions to Duvelisib Topical Gel
- timeFrame
- After each treatment administration up to Day 114
- description
- Local skin reactions will be measured as a local skin reaction score using a four-point post-treatment assessment severity scale.
- measure
- Maximum Tolerated Dose (MTD) of Duvelisib Topical Gel
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.