Actively Recruiting
A Phase II Study of Combination Extracorporeal Photopheresis and Mogamulizumab in Erythrodermic Cutaneous T Cell Lymphoma
Led by City of Hope Medical Center · Updated on 2025-10-14
34
Participants Needed
3
Research Sites
N/A
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
Researchers are evaluating a combination treatment using extracorporeal photopheresis (ECP) and mogamulizumab for patients with erythrodermic cutaneous T cell lymphoma (CTCL), a rare skin cancer affecting white blood cells called T cells. This phase II trial aims to assess the tolerability and overall response rate of this combination in patients who have not previously received mogamulizumab. The study also explores quality of life, immune response effects, and survival outcomes with this therapy. Patients receive mogamulizumab intravenously over 60 minutes on days 1, 8, 15, and 22 of the first treatment cycle, then on days 1 and 15 of subsequent cycles. Starting with cycle 2, extracorporeal photopheresis is performed over about 3 hours on days 8, 9, 22, and 23. Each treatment cycle lasts 28 days, with up to 6 cycles given if there is no disease progression or unacceptable side effects. Patients who respond after 6 cycles may receive up to 6 more cycles under the same conditions. Participants will undergo assessments including skin biopsies, blood tests, and quality of life questionnaires before, during, and after treatment. Researchers will monitor treatment response, survival, side effects, and immune effects for up to one year following treatment. Follow-up visits occur 30 days after treatment completion and continue for up to 12 months to observe long-term effects and safety.
CONDITIONS
Brief Title
Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent and assent if applicable
- Agreed to allow use of archival tissue from diagnostic tumor biopsies or received approval for exception
- Aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Histologically confirmed mycosis fungoides or Sezary syndrome, meeting stage IB or higher criteria
- Measurable disease by Modified Severity Weighted Assessment Tool (mSWAT) and/or Sezary count
- Baseline skin biopsy within 6 months available for central review
- Adequate blood counts and organ function based on specified laboratory values
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during and for 3 months after treatment
- Stable doses of prophylactic antibiotics if history of staphylococcus colonization
You will not qualify if you...
- Prior treatment with mogamulizumab
- Systemic therapy, monoclonal antibody, chemotherapy, radiation, biological therapy, or immunotherapy within specified recent timeframes prior to starting protocol therapy
- Skin-directed therapy or radiation therapy within 14 to 21 days before treatment start
- Use of immunosuppressive medication within 14 days prior to treatment with some exceptions for stable low-dose steroids or topical steroids
- Live attenuated vaccine within 30 days before treatment
- Recent or active infections including hepatitis B, hepatitis C, or syphilis
- Other active malignancies or history of certain malignancies without adequate remission
- Pregnant or breastfeeding women
- Prior stem cell transplantation
- Acute or chronic infections needing systemic treatment
- Conditions requiring ongoing steroid or immunosuppressive therapy likely to interfere with study
- Renal failure requiring dialysis
- Unstable cardiac disease or recent major surgery
- Active autoimmune or inflammatory disorders requiring therapy within 3 years with some exceptions
- History of primary immunodeficiency
- Any condition that contraindicates study participation for safety or compliance reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 cycles of 28-day cycles
Participants receive mogamulizumab intravenously on specified days each 28-day cycle and undergo extracorporeal photopheresis starting in cycle 2. Treatment may continue for up to 6 cycles, with up to 6 additional cycles for those achieving partial or complete response, if no disease progression or unacceptable toxicity occurs.
Weekly visits during cycle 1; twice monthly visits starting cycle 2 for up to 12 cycles
Duration - Up to 12 months
After completing study treatment, participants are followed for safety and outcomes including response and survival.
1 visit at 30 days post treatment and periodic visits up to 12 months
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here