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
Trial Parameters
Brief Summary
To study the safety and effectiveness of tofacitinib 2% cream in treating early-stage CTCL.
Eligibility Criteria
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) can be enrolled. * Participants must be B0 (absence of significant blood involvement: .5% of peripheral blood lymphocytes of \<250/mcL are atypical. * Have at least 2 distinct lesions that have either failed or recurred despite treatment with 1 previous standard therapy. * ECOG performance status ≤ 2 (Karnofsky .60%) * Participants with a prior or concurrent malignancy whose natural history or treatme