Phase 2 Study on Tofacitinib 2% Cream for Treating Early-Stage Cutaneous T-cell Lymphoma (CTCL)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06698822

Provider View

This clinical trial is testing the safety and effectiveness of a cream containing 2% tofacitinib for treating early-stage cutaneous T-cell lymphoma (CTCL).

Patient Parameters

Program Overview

The study aims to determine if tofacitinib 2% cream is safe and effective in treating early-stage CTCL, specifically stages IA, IB, and IIA. Researchers will evaluate how well the cream works in reducing the severity of skin lesions over a 12-week period and beyond for those who continue treatment.

Description

The main goals of this study are to see if tofacitinib 2% cream is safe to use and how well it works in treating early-stage CTCL. Researchers will look at how the cream affects skin lesions at different times, such as 12 weeks, and for those who continue, up to 52 weeks. They will also assess how quickly and how long the cream works, as well as its impact on itching and quality of life. Additionally, the study will explore changes in certain tumor markers before and after treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of early-stage CTCL (stages IA, IB, or IIA) with a skin biopsy.
  • For stage IIA, must not have significant lymph node involvement.
  • Must not have significant blood involvement.
  • Have at least two skin lesions that have not improved with previous treatment.
  • Be in good general health with a performance status score of 2 or less.
  • Women and men must agree to use effective birth control during the study and for a period after.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Allergic reactions to similar medications as tofacitinib.
  • Skin infections or ulcers at the start of the study.
  • Active cancer or cancer needing treatment during the study, except for certain skin cancers.
  • Serious health conditions that could interfere with the study.
  • History of more advanced CTCL or aggressive forms of the disease.
  • Recent treatments like skin radiation or certain topical medications.
  • Not fully recovered from side effects of previous cancer treatments.
  • Currently using other experimental treatments.
  • Uncontrolled health issues or psychiatric conditions that could affect participation.
  • Pregnant or breastfeeding women, due to unknown effects on the baby.

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