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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

History of allergic reactions attributed to compounds of similar chemical or biologic composition to tofacitinib

Skin infection and/or skin ulceration at screening and baseline visit

Any subject with a diagnosis of active malignancy or a cancer requiring treatment of expected to require treatment during the course of the trial (not including basal cell carcinoma, squamous cell carcinoma of the skin, malignant melanoma in situ, or cervical carcinoma in situ)

Any uncontrolled or serious underlying disease or medical or surgical condition that may interfere with interpretation of the trial results and/or place the subject at significant risk according to investigator discretion including but not limited to severe cardiac, psychiatric, hematologic, and thyroid conditions

Trial design

Treatments tested in this trial

  • tofacitinib 2% cream

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators