Study on Ritlecitinib for Cutaneous T-Cell Lymphoma (CTCL)

Sponsor: Icahn School of Medicine at Mount Sinai

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05879458

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, Ritlecitinib, for treating Cutaneous T-Cell Lymphoma (CTCL), a rare cancer affecting the skin and blood. The study involves a 24-week treatment period followed by a 24-week follow-up period, with various medical tests and assessments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well Ritlecitinib works and how safe it is for people with Cutaneous T-Cell Lymphoma (CTCL), a rare type of cancer that starts in white blood cells and can cause skin rashes or tumors. Participants will undergo a 24-week treatment period and a 24-week follow-up period. The study will include physical exams, lab tests, PET-CT scans, heart tests, skin photos, skin biopsies, and hearing tests to monitor the effects of the treatment.

Description

Participants will first provide informed consent and then be screened to see if they qualify for the study. This includes checking medical history, current medications, and performing various tests like blood tests, heart tests, and scans. If eligible, participants will start the study with baseline assessments, including physical exams, skin evaluations, and blood tests.

Participants will take an oral dose of Ritlecitinib daily for 24 weeks. They will visit the clinic every 2-4 weeks for check-ups, which include physical exams, monitoring of any side effects, and taking photos of skin lesions. Skin biopsies will be done at the start and end of the treatment period, and possibly at the 12-week mark.

Throughout the study, participants will have regular blood tests to monitor their health and the drug's effects. Women of childbearing potential will have pregnancy tests at various points. The study aims to gather data on the drug's safety and effectiveness in treating CTCL.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have CTCL affecting more than 10% of the body surface area, confirmed by a doctor.
  • Eligible CTCL types include Mycosis Fungoides and Sézary Syndrome.
  • Must have tried at least two previous treatments that didn't work or caused side effects.
  • Must have good blood, liver, and kidney function.
  • Must be able to take oral medication without altering it.
  • Must be able to understand and sign a consent form.
  • Must be able to communicate well with the study team and follow study requirements.

Exclusion Criteria

  • Have a significant illness or condition that could affect the study.
  • Have been on certain cancer treatments recently.
  • Pregnant or breastfeeding women.
  • Not willing to use contraception during the study.
  • Have uncontrolled illnesses like severe heart or liver disease.
  • Have another type of cancer, except for certain skin cancers.
  • Have HIV or active Hepatitis B or C.
  • Have untreated or inadequately treated tuberculosis.
  • Have had major surgery recently.
  • Have a history of certain viral infections.
  • Have been on certain medications recently that could interfere with the study.
  • Have a history of drug or alcohol abuse.
  • Have a history of blood clots or bleeding disorders.
  • Have other skin conditions that could interfere with the study.
  • Have received a live vaccine recently.
  • Have certain hearing conditions or diseases.

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