NCT06698822

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To study the safety and effectiveness of tofacitinib 2% cream in treating early-stage CTCL.

Detailed 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 overall response by mCAILS score * To assess pruritus using the visual analog scale at baseline, 4 weeks, 8 weeks, and 12 weeks * To assess health-related quality of life using the Skindex-29 instrument at baseline, 4 weeks, 8 weeks, and 12 weeks To characterize the JAK/STAT biomarker profile of tumors and characterize the mutational landscape in tumors before and after therapy

Conditions

• Cutaneous T-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	tofacitinib 2% cream	Given topical

Timeline

• Start date: 2025-03-10
• Primary completion: 2026-10-19
• Completion: 2026-10-19
• First posted: 2024-11-21
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study