Ritlecitinib in CTCL

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05879458
Phase
PHASE2
Status
Terminated

Conditions

  • CTCL
  • Mycosis Fungoides
  • Sezary Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ritlecitinib — DRUG
    200 mg QD for 8 weeks followed by 100 mg for 16 weeks

Study Details

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.

Key Dates

Start date
May 17, 2023
Status verified
Jul 2025
Primary completion
Jun 25, 2025
Completion
Jun 25, 2025

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Open-Label Ritlecitinib

Primary Outcome Measure

Change in Modified Severity Weighted Assessment Tool (mSWAT) [ Time Frame: Baseline and Week 24 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

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Icahn School of Medicine at Mount Sinai· New York, NY

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