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
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To study the safety and effectiveness of tofacitinib 2% cream in treating early-stage CTCL.
CONDITIONS
Official 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.
- Clinical diagnosis of cutaneous T-cell lymphoma (CTCL) stage IA, IB, or IIA confirmed by skin biopsy.
- For stage IIA, lymph node classification must be N0 or N1.
- No significant blood involvement (B0 status).
- At least two distinct lesions that failed or recurred after one prior standard therapy.
- ECOG performance status of 2 or less (Karnofsky score 60% or higher).
- Prior or concurrent malignancies allowed if they do not interfere with study assessments.
- Women of child-bearing potential and men must agree to use effective contraception during and after the study as specified.
- 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, except certain skin or cervical cancers in situ.
- Serious uncontrolled medical or surgical conditions including severe cardiac, psychiatric, hematologic, or thyroid diseases.
- History of Stage IIB or higher CTCL, or stage IIA with advanced lymph node involvement or >5% circulating Sezary cells.
- History of aggressive CD8+ CTCL.
- Recent treatments within defined periods: total skin electron beam therapy (12 weeks), topical imiquimod (8 weeks), topical corticosteroids, chemotherapy, retinoids, local radiation, UVB, PUVA, photopheresis, systemic retinoids, corticosteroids, interferon inducers, or chemotherapy (4 weeks).
- Unresolved adverse events from prior anti-cancer therapy except alopecia.
- Use of other investigational agents.
- Uncontrolled intercurrent illness.
- Psychiatric or social conditions limiting study compliance.
- Pregnant or breastfeeding women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Julia Dai, MD
CONTACT
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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