Actively Recruiting
Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma
Led by City of Hope Medical Center · Updated on 2025-10-14
34
Participants Needed
3
Research Sites
295 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies the effect of extracorporeal photopheresis (ECP) and mogamulizumab in treating patients with erythrodermic cutaneous T cell lymphoma (CTCL), a type of skin lymphoma. CTCL is a rare type of cancer that begins in the white blood cells called T cells. Erythrodermic is a widespread red rash that may cover most of the body. ECP is a medical treatment that removes blood with a machine, isolates white blood cells and exposes them to ultra violet light, then returns the cells to the body. Mogamulizumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving mogamulizumab with ECP may work together to kill the tumor cells directly (with mogamulizumab) and boost immune response to cancer (with ECP).
CONDITIONS
Official Title
Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and assent when appropriate
- Agreement to use archival tumor biopsy tissue or obtain approval for exceptions
- Age 18 years or older
- ECOG performance status 0 to 2
- Histologically confirmed mycosis fungoides or Sezary syndrome at specified stages
- Measurable disease by mSWAT or Sezary count
- Baseline skin biopsy within 6 months available for review
- Adequate blood counts and organ function as defined by specific laboratory values
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception or abstain from heterosexual activity during and for 3 months after treatment
- Stable prophylactic antibiotics if history of staphylococcus colonization
- Meets institutional infectious disease testing requirements
You will not qualify if you...
- Prior treatment with mogamulizumab
- Systemic therapy including monoclonal antibodies within 28 days prior to treatment
- Chemotherapy, radiation, biologic, or immunotherapy within 21 days prior to treatment
- Skin-directed therapy within 14 days prior to treatment
- Immunosuppressive medication within 14 days prior to treatment with some exceptions
- Live attenuated vaccine within 30 days prior to treatment
- Recent or active infections requiring antibiotics or systemic treatment
- Known active hepatitis B or C infection
- Other active malignancies
- Pregnant or breastfeeding women
- Prior stem cell transplantation
- Renal failure requiring dialysis
- Unstable cardiac disease including recent myocardial infarction or severe heart failure
- Major surgery within 28 days prior to treatment
- Active autoimmune or inflammatory disorders requiring recent therapy with some exceptions
- History of primary immunodeficiency
- Any condition or circumstance that would interfere with study participation or safety as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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