Tofacitinib Cream for Cutaneous T-Cell Lymphoma

Overseen By Julia Dai, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Topical corticosteroids, Systemic corticosteroids

Disqualifiers: Active malignancy, Uncontrolled illness, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop using certain treatments before starting, such as topical corticosteroids, chemotherapy, and other therapies within specific timeframes. It's best to discuss your current medications with the trial team to see if they need to be paused.

What data supports the effectiveness of the drug tofacitinib for treating cutaneous T-cell lymphoma?

Tofacitinib has been shown to be effective in treating other inflammatory and autoimmune conditions like psoriatic arthritis and rheumatoid arthritis, where it helps reduce symptoms and improve physical function. While specific data for cutaneous T-cell lymphoma is not available, its success in similar conditions suggests potential benefits. ^{1 2 3 4 5}

Is Tofacitinib cream safe for use in humans?

Tofacitinib has been studied in various forms, including oral doses, and has shown a reasonable safety profile in clinical trials for conditions like rheumatoid arthritis. Common mild side effects include nausea and headache, with no serious adverse events reported in healthy volunteers. ^{1 4 6 7 8}

How is the drug tofacitinib unique for treating cutaneous T-cell lymphoma?

Tofacitinib is unique because it is a Janus kinase (JAK) inhibitor, which is a different mechanism of action compared to traditional treatments for cutaneous T-cell lymphoma. It is also administered as a cream, offering a novel topical route for this condition. ^{1 2 5 9 10}

What is the purpose of this trial?

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

Research Team

Julia Dai, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Women of child-bearing potential and men must use adequate contraception.

I agree to use contraception.

My cancer is at stage IIA and has not spread to many lymph nodes.

Exclusion Criteria

I do not have any serious health issues that could affect the study's outcome.

I still have side effects from cancer treatment, except for hair loss.

Pregnant or breastfeeding women are excluded.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply tofacitinib 2% cream twice daily on up to 5 treatment-eligible skin lesions

12 weeks

Visits at baseline, 4 weeks, 8 weeks, and 12 weeks

Extension

Participants may choose to extend treatment with assessments at weeks 20, 28, 36, 44, and 52

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tofacitinib

Trial Overview The trial is testing the safety and effectiveness of a topical medication called tofacitinib 2% cream in treating patients with early-stage CTCL.

Participant Groups

Group I: Tofacitinib 2% Experimental Treatment 1 Intervention

Participants will apply a thin layer of tofacitinib 2% cream 2 times a day on up to 5 treatment-eligible skin lesions.

Tofacitinib is already approved in United States, European Union for the following indications:

Approved in United States as Xeljanz for:

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Ulcerative Colitis
• Ankylosing Spondylitis
• Polyarticular Course Juvenile Idiopathic Arthritis

Approved in European Union as Xeljanz for:

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Ulcerative Colitis
• Ankylosing Spondylitis

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

Tofacitinib, a selective Janus kinase inhibitor, shows promising efficacy in treating various dermatological conditions such as psoriasis, alopecia areata, vitiligo, and atopic dermatitis, based on a review of 43 studies.

Despite its potential benefits, there are safety concerns regarding tofacitinib's overall profile, indicating that further research is needed to establish a favorable risk-to-benefit ratio for its use in dermatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tofacitinib, an Oral Janus Kinase Inhibitor: Perspectives in Dermatology. Kostovic, K., Gulin, SJ., Mokos, ZB., et al.[2018]

Tofacitinib, an oral JAK inhibitor, demonstrated bioequivalence to Xeljanz® in a phase I trial involving 32 healthy Chinese subjects, with pharmacokinetic parameters such as peak concentration and area under the curve falling within the acceptable range of 80-125%.

The safety profile of tofacitinib was found to be comparable to that of Xeljanz®, supporting its potential for clinical use in treating inflammatory and autoimmune diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, crossover, phase I clinical study to evaluate bioequivalence and safety of tofacitinib and Xeljanz® in Chinese healthy subjects. Xu, Z., Wang, Y., Liu, Z., et al.[2022]

Tofacitinib (5 mg twice daily) significantly improves key symptoms of active psoriatic arthritis (PsA) and related conditions after 3 months of treatment, with benefits maintained for up to 30 months in ongoing studies.

The drug has an acceptable safety profile, showing low rates of serious infections, malignancies, and other adverse events over 36 months, indicating it is a viable option for patients who have not responded to previous therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tofacitinib: A Review in Psoriatic Arthritis. Paik, J., Deeks, ED.[2020]

Tofacitinib, a pan Janus kinase inhibitor, has shown efficacy as a standalone treatment for patients new to methotrexate and those who did not respond fully to it, as well as in combination with other drugs for patients who failed TNF inhibitors, leading to its approval for use in many countries.

The clinical trials demonstrated a reasonable safety profile for tofacitinib, with ongoing assessments in long-term studies and postmarketing reports confirming its safety in diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tofacitinib in the treatment of active rheumatoid arthritis in adults. Fleischmann, R.[2018]

Tofacitinib, an oral Janus kinase inhibitor, was found to be safe and well-tolerated in a study involving 95 healthy participants, with only mild adverse events like nausea and headache reported.

The pharmacokinetics of tofacitinib showed rapid absorption and elimination, indicating that it reaches peak serum concentration quickly and is eliminated from the body efficiently, which is important for its potential therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and pharmacokinetics of single oral doses of tofacitinib, a Janus kinase inhibitor, in healthy volunteers. Krishnaswami, S., Boy, M., Chow, V., et al.[2022]

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Tofacitinib, an Oral Janus Kinase Inhibitor: Perspectives in Dermatology. [2018]

2. Canada pubmed.ncbi.nlm.nih.gov

Treatment With Tofacitinib in Refractory Psoriatic Arthritis: A National Multicenter Study of the First 87 Patients in Clinical Practice. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Off-label studies on tofacitinib in dermatology: a review. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized, crossover, phase I clinical study to evaluate bioequivalence and safety of tofacitinib and Xeljanz® in Chinese healthy subjects. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Tofacitinib: A Review in Psoriatic Arthritis. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Tofacitinib in the treatment of active rheumatoid arthritis in adults. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and pharmacokinetics of single oral doses of tofacitinib, a Janus kinase inhibitor, in healthy volunteers. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Tofacitinib]. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

Herpes zoster as a cause of atypical chronic ulcerations associated with tofacitinib. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Herpes zoster in psoriasis patients treated with tofacitinib. [2022]