Ritlecitinib for Cutaneous T-Cell Lymphoma

Overseen by Patrick Brunner, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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 (CTCL). CTCL is a rare type of cancer that starts in the white blood cells and eventually can result in rashes or tumors in the skin. This study includes a 24 week Treatment Period and a 24 week Follow-up Period. This study will involve physical examinations, visual assessments, laboratory tests, PET-CT scans, electrocardiograms, photographs of your skin, skin biopsies, and hearing tests.

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.

How is the drug Ritlecitinib different from other treatments for cutaneous T-cell lymphoma?

Ritlecitinib is unique because it is a targeted therapy, which means it specifically aims at certain pathways or proteins involved in the disease process, potentially offering a more precise treatment option compared to traditional therapies like chemotherapy or radiation. ^{1 2 3 4 5}

Research Team

Patrick Brunner, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Ritlecitinib (Janus Kinase (JAK) Inhibitor)

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.

Participant Groups

Group I: Treatment Arm Experimental Treatment 1 Intervention

Open-Label Ritlecitinib

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

Findings from Research

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Therapeutic advances in cutaneous T-cell lymphoma. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Cutaneous T-cell lymphomas: Focusing on novel agents in relapsed and refractory disease. [2017]

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

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

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

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

5. England pubmed.ncbi.nlm.nih.gov

Cutaneous T-cell lymphomas-An update 2021. [2021]