Ritlecitinib in CTCL

NCT05879458 | Terminated Phase 2 FDA Drug

• 1 other identifier: GCO 23-0107
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CTCL; Mycosis Fungoides; Sezary Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Modified Severity Weighted Assessment Tool (mSWAT)

  Change in Modified Severity Weighted Assessment Tool (mSWAT) at Week 24 from baseline. Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL. Responses in the skin based on SWAT are defined as: Complete Response (CR): no evidence of skin disease Partial Response (PR): ≥ 50% decrease of the modified SWAT score compared with baseline Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score Progressive Disease (PD): ≥ 25% increase in the modified SWAT score compared with baseline.

  Baseline and Week 24

Secondary Outcomes (12)

• Change in Modified Severity Weighted Assessment Tool (mSWAT)

  Baseline and at each visit from week 2 to week 48 / EOS except for week 24

• Treatment Emergent Adverse Events

  up to Week 48/EOS

• Number of Serious Adverse Events

  up to Week 48/EOS

• Number of Adverse Events

  up to Week 48/EOS

• Number of clinically significant abnormalities in vital signs

  up to Week 48/EOS

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Open-Label Ritlecitinib

Drug: Ritlecitinib

Interventions

Ritlecitinib DRUG

200 mg QD for 8 weeks followed by 100 mg for 16 weeks

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at time of enrollment
• CTCL \>10% BSA involvement (stage IB-IVA by ISCL/EORTC staging criteria), previously confirmed by histopathology
• CTCL subtypes eligible for this study include Mycosis fungoides and its subtypes, as well as Sézary Syndrome.
• Failure of at least 2 skin-directed (ISCL/EORTC stage IB-IIA, i.e. early stage disease) or systemic treatments (ISCL/EORTC stage IIB-IVA, i.e. late stage disease) due to progression or toxicity as assessed by the prescribing physician or by the principal investigator, or insufficient response to established skin-directed or systemic treatments.
• i. Patients with documented CD30-positive CTCL must have previously received or be intolerant to brentuximab vedotin.
• Adequate hematological (Hb\>9.0g/dl, absolute neutrophil count \>1200/ul, platelets \>75x10\^9/L, absolute \[non-malignant\] lymphocyte count \>800/ul), hepatic (AST and ALT \<2x times upper limit of normal), and renal function (eGFR \[CKD-EPI creatinine equation \>50mL/min/1.73m2)
• ECOG ≤ 2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death.)
• Ability to take oral medication without crushing, dissolving or chewing tablets
• Ability to understand and the willingness to sign a written informed consent
• In the investigator's opinion, the patient has the ability to communicate satisfactorily with the investigator and the study team, to participate fully in the study, and comply with all requirements

You may not qualify if:

• History of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study
• Immunosuppressed by previous (within 4 weeks) or current systemic cytotoxic therapies, as evidenced by recurrent skin or systemic infections
• Pregnant or breast-feeding women
• Unwillingness or inability to use a contraception method during the time of participation in the trial.
• Uncontrolled current illness, including, but not limited to the following: Ongoing or active infections requiring intravenous antimicrobials; symptomatic congestive heart failure defined as NYHA class III or IV; unstable angina pectoris within 6 months of study enrollment; history of myocardial infarction, stroke or intracranial hemorrhage within 6 months prior to enrollment; moderate to severe hepatic impairment (Child-Pugh class B or C); psychiatric illness or social situations that would limit compliance with study requirements
• Previous or concurrent cancer that is distinct in primary site or histology form CTCL, except curatively treated basal or squamous cell carcinoma of the skin, and curatively treated malignant melanoma stage 0-1A with a low risk of recurrence/metastasis as per assessment of the investigator, cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1)
• Known HIV infection
• Infected with Hepatitis B or Hepatitis C viruses
• Patients with history of either untreated or inadequately treated latent or active TB infections/currently being treated for active TB.
• Recent (within 21 days before baseline) major surgery
• Patients who have history of single episode of disseminated HZ or disseminated HS or recurrent (\> 1 episode of) localized dermatomal HZ should be excluded.
• Less than 28 days have elapsed since last radiation therapy, phototherapy or chemotherapy treatment or patient has not recovered from all clinically significant treatment-related toxicity as defined in discontinuation criteria.
• Less than 3 months have elapsed since last oral JAK inhibitors and/or less than 4 weeks have elapsed since last topical JAK inhibitor.
• Glucocorticosteroids when used systemically; the use of nasal and inhaled glucocorticosteroids will be allowed PRN; the use of topical glucocorticosteroids (low to mid-potency) will only be allowed when given at a stable dose \>4 weeks
• Prior treatment with other concomitant investigational agents

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Pfizer: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Mycosis Fungoides; Sezary Syndrome

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Patrick Brunner, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Open-Label

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 30, 2023
• Study Start: May 17, 2023
• Primary Completion: June 25, 2025
• Study Completion: June 25, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)