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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

Must not have

Other active malignancy

Renal failure requiring hemodialysis or peritoneal dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any other active cancer.

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I require dialysis for kidney failure.

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I have had a stem cell transplant before.

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I have hepatitis B or C.

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I have previously received mogamulizumab treatment.

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I am not pregnant or breastfeeding.

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I am currently being treated for a serious infection.

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I have not received a live vaccine in the last 30 days.

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I am currently taking antibiotics for an infection.

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I do not have unstable heart conditions.

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I am on long-term steroids or immunosuppressants and might need more during the trial.

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I haven't had any drug treatments for my condition in the last 28 days or 5 half-lives, whichever is shorter.

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I haven't had chemotherapy, radiation, or immunotherapy in the last 21 days.

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I have had an autoimmune or inflammatory disorder that needed treatment in the last 3 years.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (ORR)

Secondary study objectives

Complete response rate

Duration of response

Incidence of adverse events

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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