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

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 treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

* The effects of tofacitinib on the developing human fetus are unknown. Available data with tofacitinib in its oral formulation in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Therefore, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:

1. Postmenopausal (no menses in greater than or equal to 12 consecutive months)

2. History of hysterectomy or bilateral salpingo-oophorectomy

3. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)

4. History of bilateral tubal ligation or another surgical sterilization procedure

* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of tofacitinib administration.

* Ability to understand and the willingness to sign a written informed consent document.

What this study is about