RECRUITING

A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is being done to assess mogamulizumab-associated rash in patients diagnosed with mycosis fungoides or sezary syndrome and treated with standard of care mogamulizumab. One of the most common side effects of mogamulizumab is a rash, currently named mogamulizumab-associated rash (MAR) which can look like MF or SS. However, mogamulizumab-associated rash (MAR) does not indicate failure of mogamulizumab, and may be a sign that the drug is working. If not properly evaluated, mogamulizumab-associated rash (MAR) could be misinterpreted as worsening of mycosis fungoides/sezary syndrome, which could lead doctors to recommend stopping mogamulizumab treatment early. The information learned by doing this research study may help tell the difference between mogamulizumab-associated rash (MAR) (sometimes also called "drug eruption") and worsening of the disease. It may also help to uncover information about the cause of mogamulizumab-associated rash (MAR).

Official Title

A Prospective, US-Based Study Assessing Mogamulizumab-Associated Rash in Patients Diagnosed With Mycosis Fungoides or Sézary Syndrome and Treated With Standard of Care Mogamulizumab

Quick Facts

Study Start:2024-12-06
Study Completion:2026-10-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07003100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \* Adult patients (\>= 18 years of age) diagnosed with relapsed/refractory Mycosis Fungoides (MF) stage IB, IIA, IIB, III and IV or Sezary Syndrome(SS), and selected by their treating physician to receive single agent mogamulizumab (newly initiated)
  2. * Signed informed consent
  3. * Willing to undergo baseline biopsy and during treatment to evaluate for Mogamulizumab-Associated Rash (MAR) if clinically indicated
  4. * Willing to provide blood sample at baseline, and if applicable, at onset of Mogamulizumab-Associated Rash (MAR)
  1. * \* Other concomitant systemic and skin directed Cutaneous T-cell Lymphoma (CTCL) regimens except for topical steroids
  2. * Prior treatment with mogamulizumab

Contacts and Locations

Principal Investigator

Christiane Querfeld
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Siteman Cancer Center at Washington University
Saint Louis, Missouri, 63110
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Christiane Querfeld, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-06
Study Completion Date2026-10-19

Study Record Updates

Study Start Date2024-12-06
Study Completion Date2026-10-19

Terms related to this study

Additional Relevant MeSH Terms

  • Recurrent Mycosis Fungoides
  • Recurrent Sezary Syndrome
  • Refractory Mycosis Fungoides
  • Refractory Sezary Syndrome
  • Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8
  • Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8
  • Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8
  • Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8
  • Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8