Ritlecitinib for Cutaneous T-Cell Lymphoma

Overseen By Patrick Brunner, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Glucocorticosteroids, JAK inhibitors

Disqualifiers: HIV, Hepatitis B/C, Active TB, 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: 5

Duration: 24 weeks

7 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness and safety of a drug called Ritlecitinib for individuals with Cutaneous T-Cell Lymphoma (CTCL), a rare cancer affecting the skin and white blood cells. Participants will undergo various tests and assessments over 48 weeks. Ideal candidates for this trial include those with CTCL who have experienced treatment failure with at least two other therapies and have skin involvement covering more than 10% of their body. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, certain medications, like systemic glucocorticosteroids and JAK inhibitors, must be stopped for a specific period before joining the trial. It's best to discuss your current medications with the study team to see if any adjustments are needed.

Is there any evidence suggesting that Ritlecitinib is likely to be safe for humans?

Research has shown that Ritlecitinib is being tested for its safety and effectiveness in treating Cutaneous T-Cell Lymphoma (CTCL). People who have taken Ritlecitinib for other conditions generally tolerated it well. However, since it is now being tested specifically for CTCL, more information is needed to fully understand its safety for this use.

In earlier studies, some participants experienced mild to moderate side effects, such as headaches or stomach issues, while serious side effects were less common. Although these results are encouraging, more research is needed to confirm the treatment's safety for CTCL. Prospective participants should consult a healthcare professional about any concerns before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Ritlecitinib is unique because it targets specific enzymes called Janus kinases (JAKs), which are involved in the signaling pathways that drive the growth of cancerous T-cells in cutaneous T-cell lymphoma. While most treatments for this condition, like chemotherapy and radiation, work by broadly attacking cancer cells, Ritlecitinib aims to be more selective, potentially reducing side effects. Researchers are excited about Ritlecitinib because its targeted approach could offer more effective management of symptoms and disease progression with a better safety profile compared to current standard treatments.

What evidence suggests that Ritlecitinib might be an effective treatment for Cutaneous T-Cell Lymphoma?

Studies have shown that Ritlecitinib may help treat Cutaneous T-Cell Lymphoma (CTCL), a rare skin cancer that starts in white blood cells and can cause skin rashes or tumors. Research suggests that Ritlecitinib affects specific parts of the immune system involved in CTCL. Early findings indicate that patients taking Ritlecitinib experienced improvements in skin and blood symptoms related to this condition. Although more information is needed, the initial results are promising for those considering this treatment. ^{1 2 3 5 6}

Who Is on the Research Team?

Patrick Brunner, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Cutaneous T-Cell Lymphoma (CTCL) who have tried at least two other treatments without success or experienced side effects. Participants must have a certain level of disease spread, be vaccinated against COVID-19 within the last year, and have good blood, liver, and kidney function. They should not be on certain medications or treatments close to the start of the trial and must be able to take oral medication.

Inclusion Criteria

I have been vaccinated against COVID-19 within the last year.

I can swallow pills without needing to crush, dissolve, or chew them.

I've had at least 2 treatments for my skin condition that didn't work due to worsening or side effects.

Exclusion Criteria

I have not had major surgery in the last 3 weeks.

I do not have stomach or metabolic issues affecting medication absorption.

My immune system is weakened due to past or current cancer treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive Ritlecitinib 200mg orally once daily for 24 weeks

24 weeks

Visits every 2-4 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Visits every 2-4 weeks (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ritlecitinib

Trial Overview The study tests Ritlecitinib's effectiveness and safety in treating CTCL over a period of 24 weeks followed by another 24 weeks of follow-up. It includes various assessments like physical exams, skin evaluations, lab tests, scans, ECGs, photographs of skin lesions, biopsies, and hearing tests.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Open-Label Ritlecitinib

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

Approved in European Union as Litfulo for:

• Severe alopecia areata

Approved in United States as Litfulo for:

• Severe alopecia areata

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Recent FDA approvals of novel agents vorinostat, romidepsin, and pralatrexate have significantly transformed the treatment landscape for cutaneous T cell lymphoma (CTCL).

These new therapies provide additional options for patients, enhancing the effectiveness of CTCL management alongside existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic advances in cutaneous T-cell lymphoma. Akilov, OE., Geskin, L.[2022]

A 74-year-old man with cutaneous T-cell lymphoma (CTCL) experienced rapid and sustained remission of his symptoms after treatment with oral bexarotene, despite having resistant ulcerative lesions.

This case highlights the potential efficacy of bexarotene as a treatment option for patients with CTCL who do not respond to multiple systemic therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained remission of treatment-resistant cutaneous T-cell lymphoma with oral bexarotene. Mehlmauer, MA.[2018]

The treatment landscape for cutaneous T-cell lymphoma has evolved significantly over the past 20 years, with ongoing research into new therapies aimed at improving effectiveness and tolerability.

Promising therapies currently under investigation include topical retinoids, fusion molecules like denileukin diftitox, and various immunotherapies, indicating a diverse approach to managing this type of lymphoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future perspectives in the treatment of cutaneous T-cell lymphoma (CTCL). Dummer, R.[2012]

Cutaneous T-cell lymphomas (CTCL), particularly Mycosis fungoides (MF) and cutaneous CD30+ lymphoproliferative disorders, account for 80% of CTCL cases, and their treatment varies significantly based on disease stage, with early-stage therapies focusing on skin-directed treatments and advanced stages requiring systemic therapies.

Novel targeted therapies, such as mogamulizumab and brentuximab vedotin, are important for treating CTCL and highlight the role of biomarkers like CD30 in both diagnosis and therapy, improving treatment outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous T-cell lymphomas-An update 2021. Kempf, W., Mitteldorf, C.[2021]

Patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) currently have limited treatment options, but new targeted therapies are showing promise in clinical trials.

Three FDA-approved treatments, including bexarotene, romidepsin, and vorinostat, are available, and participation in clinical trials is encouraged to explore new combination strategies and novel agents for better management of CTCL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous T-cell lymphomas: Focusing on novel agents in relapsed and refractory disease. Argnani, L., Broccoli, A., Zinzani, PL.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05879458

Study Details | NCT05879458 | Ritlecitinib in CTCL The purpose of this research study is to evaluate the effectiveness and safety of Ritlecitinib in skin and blood in persons with Cutaneous T-Cell Lymphoma ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-04859

Ritlecitinib for the Treatment of Patients with Cutaneous T ... This phase IIA trial tests the safety and effectiveness of ritlecitinib for the treatment of patients with cutaneous T cell lymphomas (CTCL).

3. clfoundation.org clfoundation.org/ritlecitinib-ctcl

Ritlecitinib in CTCL The purpose of this research study is to evaluate the effectiveness and safety of Ritlecitinib in skin and blood in persons with Cutaneous T-Cell Lymphoma ( ...

4. litfulo.pfizerpro.com litfulo.pfizerpro.com/efficacy/study-overview

Study Overview | LITFULO® (ritlecitinib) capsules HCP Site The primary endpoint was the proportion of patients with a SALT score ≤20 at Week 24 · Efficacy results include patients who received LITFULO 50 mg (the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12375681/

a role for the treatment of cutaneous T-cell lymphomas? Bexarotene is effective and safe for treatment of refractory advanced-stage cutaneous T-cell lymphoma: multinational phase II-III trial results.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05879458/ritlecitinib-in-ctcl

Ritlecitinib in CTCL | Clinical Research Trial Listing The purpose of this research study is to evaluate the effectiveness and safety of Ritlecitinib in skin and blood in persons with Cutaneous ...