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Janus Kinase (JAK) Inhibitor

Tofacitinib Cream for Cutaneous T-Cell Lymphoma

Houston, TX
Phase 2
Waitlist Available
Led By Julia Dai, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years at screening visit. Children are excluded from this study.
For stage IIA, only participants with N0 or N1 classification can be enrolled.
Must not have
History of Stage IIB or greater CTCL, aggressive CD8+ CTCL disease, or specific treatments within defined timeframes.
Skin infection and/or ulceration at screening and baseline visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if using tofacitinib 2% cream is safe and effective in treating early-stage CTCL."

See full description
Who is the study for?
This trial is for individuals with early-stage Cutaneous T-cell Lymphoma (CTCL), specifically stages IA, IB, and IIA. Participants should have a confirmed diagnosis of CTCL to be eligible.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a topical medication called tofacitinib 2% cream in treating patients with early-stage CTCL.See study design
What are the potential side effects?
Potential side effects of tofacitinib cream may include skin irritation at the application site, headaches, respiratory infections, and other immune-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is at stage IIA and has not spread to many lymph nodes.
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I have at least 2 cancer spots that didn't respond to my first treatment.
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I can take care of myself but might not be able to do heavy physical work.
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I have been diagnosed with early-stage cutaneous T-cell lymphoma.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My CTCL is at least stage IIB, aggressive, or I've had specific treatments recently.
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I do not have any skin infections or ulcers.
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I have cancer that needs treatment during the study.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and adverse events (AE's)

Side effects data

From 2020 Phase 4 trial • 4372 Patients • NCT02092467
22%
Upper respiratory tract infection
15%
Bronchitis
13%
Rheumatoid arthritis
13%
Urinary tract infection
12%
Nasopharyngitis
12%
Fall
12%
Herpes zoster
9%
Hypertension
8%
Arthralgia
7%
Diarrhoea
7%
Lymphopenia
7%
Sinusitis
7%
Back pain
6%
Influenza
6%
Osteoarthritis
6%
Latent tuberculosis
6%
Pharyngitis
5%
Nausea
5%
Anaemia
5%
Alanine aminotransferase increased
5%
Cough
4%
Gastroenteritis
3%
Pneumonia
3%
Headache
1%
Coronary artery disease
1%
Cellulitis
1%
Femur fracture
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib 5 mg BID
Tofacitinib 10 mg BID
TNFi

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tofacitinib 2%Experimental Treatment1 Intervention
Participants will apply a thin layer of tofacitinib 2% cream 2 times a day on up to 5 treatment-eligible skin lesions.

Find a Location

Closest Location:MD Anderson Cancer Center· Houston, TX· 993 miles
Image of MD Anderson Cancer Center in Houston, United States.Image of MD Anderson Cancer Center in Houston, United States.Image of MD Anderson Cancer Center in Houston, United States.

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,099 Previous Clinical Trials
1,812,493 Total Patients Enrolled
Julia Dai, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
100 Total Patients Enrolled
~13 spots leftby Oct 2026
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