A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2% Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, and IIA
M.D. Anderson Cancer Center
Summary
To study the safety and effectiveness of tofacitinib 2% cream in treating early-stage CTCL.
Description
Primary Objectives * To assess the safety of tofacitinib 2% cream in the treatment of early stage CTCL (stage IA, IB, or IIA) * To assess the overall response rate (ORR) of target lesions at Week 12 based upon Modified Composite Assessment of Index Lesion Severity (mCAILS) Secondary Objectives * To assess the overall response rate (ORR) of target lesions at Week 12 based upon mSWAT composite score * To assess response by mCAILS at weeks 20, 28, 36, 44, and 52 for participants that choose to extend treatment * To assess the time to overall response by mCAILS score * To assess the duration of…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥18 years at screening visit. Because limited dosing and adverse event data are currently available on the use of tofacitinib in participants \<18 years of age, children are excluded from this study. * Have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL) stage IA, IB, or IIA including documentation of a skin biopsy with histological findings consistent with CTCL. * For stage IIA, only participants with a classification of N0 (no clinically abnormal peripheral lymph nodes) or N1 (clinically abnormal lymph node(s) histopathology Dutch grade 1 or NCI LN0-2…
Interventions
- Drugtofacitinib 2% cream
Given topical
Location
- MD Anderson Cancer CenterHouston, Texas