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Ritlecitinib for Cutaneous T-Cell Lymphoma
Study Summary
This trial is testing a new drug to treat Cutaneous T-Cell Lymphoma, a type of blood cancer that can cause skin rashes/tumors. Tests incl. physical/visual exams, lab tests, skin biopsies, and more. Results will be monitored over 48 weeks.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 1 trial • 12 Patients • NCT05097716Trial Design
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Who is running the clinical trial?
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- 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.I have been vaccinated against COVID-19 within the last year.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have a skin condition that could affect skin cancer assessments.I can swallow pills without needing to crush, dissolve, or chew them.I have or had another type of cancer that is different from my current skin cancer.I have been on stable treatment for myelofibrosis for at least one month.I have ALCL or another type of CTCL, but not MF or Sézary Syndrome.I am infected with Hepatitis B or C.I have a history of blood clots or a known clotting disorder.I've had at least 2 treatments for my skin condition that didn't work due to worsening or side effects.My hearing has worsened over the last 5 years, or I've had sudden hearing loss, or have a middle/inner ear condition.My condition is either Mycosis fungoides or Sézary Syndrome.I can communicate well and follow the study's requirements.My blood, liver, and kidney functions are all within normal ranges.I am HIV positive.I am not on medications that could affect the study drug's results.I have not received a live vaccine in the last 30 days.I stopped taking JAK inhibitors less than 3 months ago.I have never had widespread or repeated shingles.I am 18 years old or older.I do not have any serious illnesses or lab abnormalities that could interfere with the study.My skin cancer covers more than 10% of my body.I haven't taken any prohibited drugs that affect drug metabolism in the last 28 days.I am taking steroids that affect my whole body.I have a history of TB, whether treated or not, or am currently being treated for TB.It's been less than 28 days since my last cancer treatment or I'm still experiencing significant side effects.I have CTCL and cannot take or have already tried brentuximab vedotin.I can take care of myself and perform daily activities.
- Group 1: Treatment Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has Treatment Arm been given regulatory approval by the FDA?
"Treatment Arm, a Phase 2 trial, is estimated to have safety of level 2 due to its lack of efficacy data but some supportive evidence regarding safety."
How many individuals are being treated in this clinical trial?
"Indeed, the details posted on clinicaltrials.gov establish that this trial is currently recruiting participants. This research was initially advertised on May 1st 2023 and its listing has been recently updated to account for new information. The study's goal is to enrol approximately 20 patients from a single site."
Is this research project presently enrolling participants?
"Affirmative. According to clinicaltrials.gov, this medical investigation is currently seeking volunteers since it was first posted on May 1st 2023 and modified more recently on the 18th of same month. In total, they are looking for 20 participants from a single site."
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