Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-04-14
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of tofacitinib 2% cream for treating early-stage Cutaneous T-cell Lymphoma (CTCL) in adults diagnosed with stages IA, IB, or IIA. This phase 2 trial aims to assess how well the cream works on skin lesions and monitor side effects. The study also looks at itch relief, quality of life, and tumor biomarkers before and after treatment. Participants will apply a thin layer of tofacitinib 2% cream twice daily on up to five eligible skin lesions. The treatment phase lasts 12 weeks, with options to extend treatment for up to one year. Researchers will evaluate responses at multiple time points, including weeks 4, 8, 12, and beyond for those continuing treatment. During the study, participants will have regular assessments of their skin lesions using specialized scoring systems, report itch severity, and complete quality of life questionnaires. Safety and adverse events will be monitored throughout the study and up to one year. Tumor samples will be analyzed to understand the biological effects of the cream. Overall participation may last about one year depending on treatment extension.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at screening visit
- Clinical diagnosis of Cutaneous T-cell Lymphoma (CTCL) stage IA, IB, or IIA confirmed by skin biopsy
- For stage IIA, only participants with N0 or N1 classification of lymph nodes can enroll
- Absence of significant blood involvement (B0 status)
- At least 2 distinct lesions that failed or recurred after 1 previous standard therapy
- ECOG performance status of 2 or less (Karnofsky 60% or higher)
- Participants with prior or concurrent malignancy not interfering with study assessment are eligible
- Women of child-bearing potential and men must agree to use adequate contraception during and after study participation
- Ability to understand and sign informed consent
You will not qualify if you...
- History of allergic reactions to tofacitinib or similar compounds
- Skin infection or ulceration at screening and baseline
- Active malignancy requiring treatment during the trial (except certain skin or cervical cancers in situ)
- Uncontrolled or serious underlying diseases that increase risk or affect results
- History of Stage IIB or greater CTCL, or stage IIA with N2 lymph node status or greater than 5% circulating Sezary cells
- History of aggressive CD8+ CTCL disease
- Received specific treatments within defined timeframes before baseline (e.g., TSEBT within 12 weeks, topical imiquimod within 8 weeks, topical corticosteroids or systemic therapies within 4 weeks)
- Unrecovered adverse events from prior anticancer therapy, except alopecia
- Receiving other investigational agents
- Uncontrolled intercurrent illness
- Psychiatric or social conditions limiting compliance
- Pregnant or breastfeeding women
- Breastfeeding must be discontinued if treated with tofacitinib due to potential risks to infant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants apply tofacitinib 2% cream twice daily on up to 5 eligible skin lesions to assess safety and efficacy for early stage CTCL.
Visits at baseline, and Weeks 4, 8, 12, 20, 28, 36, 44, and 52
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Julia Dai, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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