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Photopheresis + Mogamulizumab for Cutaneous T-Cell Lymphoma
Phase 2
Recruiting
Led By Farah R Abdulla
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: >= 18 years
Eastern Cooperative Oncology Group (ECOG) =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post treatment
Awards & highlights
Study Summary
This trial is studying the effect of combining two treatments, extracorporeal photopheresis and mogamulizumab, to treat erythrodermic cutaneous T cell lymphoma.
Who is the study for?
Adults (18+) with erythrodermic cutaneous T cell lymphoma, specifically mycosis fungoides or Sezary syndrome. Participants must have an ECOG performance status of <=2, meet certain blood and organ function criteria, agree to birth control if applicable, and can provide tissue samples. Excluded are those who've had recent cancer treatments or live vaccines, other active malignancies within 5 years (with some exceptions), unstable heart disease, autoimmune disorders in the past 3 years (with exceptions), infections needing systemic treatment, or require dialysis.Check my eligibility
What is being tested?
The trial is testing a combination therapy for skin lymphoma involving extracorporeal photopheresis—where white blood cells are treated with UV light outside the body—and mogamulizumab—a monoclonal antibody that may stop cancer growth. The study aims to see if this combo can effectively kill tumor cells and boost immune response against cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to mogamulizumab such as infusion-related symptoms (fever, chills), skin rash, fatigue; complications from extracorporeal photopheresis like low blood pressure during the procedure; and general risks associated with immunotherapies such as increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can perform daily activities with minimal assistance.
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My kidney function test shows a creatinine clearance of 60 mL/min or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Complete response rate
Duration of response
Incidence of adverse events
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ECP, mogamulizumab)Experimental Treatment4 Interventions
Patients receive mogamulizumab IV over 60 minutes on days 1, 8, 15, 22, of cycle 1 and days 1 and 15 of subsequent cycles. Beginning in cycle 2, patients also undergo ECP over 3 hours on days 8, 9, 22,and 23. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving CR)/PR after 6 cycles receive up to 6 additional cycles of treatment in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Extracorporeal Photopheresis
2004
Completed Phase 2
~40
Mogamulizumab
2016
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,426 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,647 Total Patients Enrolled
Farah R AbdullaPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
1 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any other active cancer.I require dialysis for kidney failure.My cancer's stage is known.My blood clotting time is within the target range for my anticoagulant therapy.I have had a stem cell transplant before.My liver enzyme (ALT) levels are normal or slightly elevated.My platelet count is at least 100,000/mm^3, and the test was done within the last week.I have hepatitis B or C.I am 18 years old or older.I have not had any skin treatments in the last 14 days.I have previously received mogamulizumab treatment.I am not pregnant or breastfeeding.I have been cancer-free for at least 5 years, except for certain types.I am currently being treated for a serious infection.My white blood cell count is healthy for treatment.My condition is confirmed as mycosis fungoides or Sezary syndrome, at an advanced stage.My blood clotting time is within the target range for my anticoagulant therapy.I haven't taken immunosuppressive medication in the last 14 days.I have not received a live vaccine in the last 30 days.I am currently taking antibiotics for an infection.I do not have unstable heart conditions.I have not had major surgery in the last 28 days.My blood clotting time is within the normal range and I'm not on blood thinners.I am on long-term steroids or immunosuppressants and might need more during the trial.My platelet count is at least 75,000/mm3.My blood clotting test results are within normal limits.My white blood cell count is at least 1,000/mm^3.I haven't had any drug treatments for my condition in the last 28 days or 5 half-lives, whichever is shorter.I am capable of having children and have not been surgically sterilized.I have not had radiation therapy in the last 21 days.I have mycosis fungoides and take stable doses of antibiotics for staph infection prevention.I can perform daily activities with minimal assistance.I haven't had chemotherapy, radiation, or immunotherapy in the last 21 days.My kidney function test shows a creatinine clearance of 60 mL/min or more.I have had an autoimmune or inflammatory disorder that needed treatment in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ECP, mogamulizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other similar studies that have looked at Quality-of-Life Assessment?
"There are 10 clinical trials studying Quality-of-Life Assessment, with 0 in Phase 3. Many of the studies are being conducted in Bethesda, Maryland, but there are a total of 47 locations running studies on this topic."
Answered by AI
How much risk is involved in the Quality-of-Life Assessment procedure?
"Quality-of-Life Assessment is still being clinically tested for efficacy, so it received a score of 2."
Answered by AI
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