What this study is
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).
What's being tested
- Non-Interventional Study
Intervention · OTHER
Non-interventional study
Study details
- 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
- Sponsor
- City of Hope Medical Center
- Conditions
- 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
- Enrolling
- 100 people
- Starts
- 2024-12-06
- Est. completion
- 2027-01-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
- Signed informed consent
- Willing to undergo baseline biopsy and during treatment to evaluate for Mogamulizumab-Associated Rash (MAR) if clinically indicated
- Willing to provide blood sample at baseline, and if applicable, at onset of Mogamulizumab-Associated Rash (MAR)
You can't join if
- Other concomitant systemic and skin directed Cutaneous T-cell Lymphoma (CTCL) regimens except for topical steroids
- Prior treatment with mogamulizumab
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (10)
10 openCity of Hope Medical Center
Duarte, California, United States
- Christiane Querfeld · Contact626-218-9018cquerfeld@coh.org
- Christiane Querfeld · Principal investigator
RecruitingStanford Cancer Institute Palo Alto
Palo Alto, California, United States
- Youn H. Kim · Contact650-498-6000younkim@stanford.edu
- Youn H. Kim · Principal investigator
Not yet recruitingMoffitt Cancer Center
Tampa, Florida, United States
- Pei-Ling Chen · Contact813-745-6586Pei-Ling.Chen@moffitt.org
- Pei-Ling Chen · Principal investigator
Not yet recruitingEmory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
- Pamela B. Allen · Contact559-817-8872pamela.b.allen@emory.edu
- Pamela B. Allen · Principal investigator
Not yet recruitingJohns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
- Sima Rozati · Contact419-955-1573srozati1@jhmi.edu
- Sima Rozati · Principal investigator
Not yet recruitingBrigham and Women's Hospital
Boston, Massachusetts, United States
- Cecilia A. Larocca · Contact646-483-8936clarocca@BWH.harvard.edu
- Cecilia A. Larocca · Principal investigator
Not yet recruitingSiteman Cancer Center at Washington University
St Louis, Missouri, United States
- Neha Mehta Shah · Contact314-747-3057amusiek@wustl.edu
- Neha Mehta Shah · Principal investigator
RecruitingThomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
- Neda Nikbakht · Contact215-503-4834Neda.Nikbakht@jefferson.edu
- Neda Nikbakht · Principal investigator
Not yet recruitingM D Anderson Cancer Center
Houston, Texas, United States
- Auris Huen · Contact713-792-2121aohuen@mdanderson.org
- Auris Huen · Principal investigator
Not yet recruitingFred Hutchinson Cancer Center
Seattle, Washington, United States
- Michi M. Shinohara · Contact206-616-8523mshinoha@uw.edu
- Michi M. Shinohara · Principal investigator
Not yet recruiting
Study team
Sponsor
City of Hope Medical Center
Study ID 22233
Principal investigator
Christiane Querfeld
City of Hope Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.