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Janus Kinase (JAK) Inhibitor
Ritlecitinib for Cutaneous T-Cell Lymphoma
Phase 2
Recruiting
Led By Patrick Brunner, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at each visit from week 2 to week 48 / eos except for week 24
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects for Ritlecitinib are not listed here; generally such drugs can cause immune system reactions leading to inflammation in different organs. Other possible side effects might include fatigue, digestive issues like nausea or diarrhea; changes in blood counts; potential impact on liver enzymes; as well as risks associated with taking any oral medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and at each visit from week 2 to week 48 / eos except for week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at each visit from week 2 to week 48 / eos except for week 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Absolute change of IPQ-R (Illness perception questionnaire)
Absolute change of health-related quality of life (FACT-G)
Absolute change of health-related quality of life (Skindex-29)
+9 moreSide effects data
From 2022 Phase 1 trial • 12 Patients • NCT0509771610%
Nail disorder
10%
Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2: Ritlecitinib
Period 1: Tolbutamide
Period 2: Ritlecitinib + Tolbutamide
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Open-Label Ritlecitinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ritlecitinib
2020
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,801 Total Patients Enrolled
PfizerIndustry Sponsor
4,660 Previous Clinical Trials
17,877,295 Total Patients Enrolled
Patrick Brunner, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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