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Mogamulizumab + LD TSEBT for Cutaneous Lymphoma

Phase 2

Recruiting

Led By Youn H Kim, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of graft vs host disease (GvHD) and receiving immunosuppressive therapy.

≥ 2 weeks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod)

Must not have

Known human immunodeficiency virus (HIV) positivity; known human T-cell lymphotropic virus (HTLV-1) infection; or active hepatitis B or C.

MF with limited disease (Stage IA) or central nervous system (CNS) disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs to see if it is effective in treating patients with mycosis fungoides or Sézary syndrome. It will also look at the safety and side effects of the combination.

Who is the study for?

Adults with stages 1B-IV Mycosis Fungoides or Sézary Syndrome who've had at least one prior treatment can join. They should be in decent health, with good organ function and no severe autoimmune diseases, HIV, HTLV-1, or active hepatitis. Pregnant women and those on high-dose steroids are excluded.

What is being tested?

The trial tests a combination of Mogamulizumab (an immunotherapy drug) and Low-Dose Total Skin Electron Beam Therapy (LD-TSEBT), which is a type of radiation therapy for skin involvement in these conditions to see how effective they are together.

What are the potential side effects?

Possible side effects include skin reactions from LD-TSEBT and immune-related effects from Mogamulizumab such as rash, fatigue, nausea, infusion reactions, and potential 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 had a stem cell transplant and don't have GvHD or need immunosuppressive therapy.

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I haven't used any skin creams for my condition in the last 2 weeks.

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My liver enzymes are within the required limits, even with my liver condition.

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I have completed skin electron beam therapy more than 12 weeks ago.

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Any side effects from my previous cancer treatments are mild.

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I am able to get out of my bed or chair and move around.

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I am 18 years old or older.

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My cancer is between stages 1B and IV.

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I have had one standard treatment for my condition.

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My kidneys are functioning well, with a creatinine clearance rate over 50 mL/min.

Exclusion Criteria

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

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I have HIV, HTLV-1, or active hepatitis B or C.

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My condition is early-stage mycosis fungoides or affects the central nervous system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years 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

Duration of response (DOR)

Patient reported Quality of Life (QoL)

Progression free survival (PFS)

+2 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: LD TSEBTExperimental Treatment2 Interventions

Mogamulizumab with low dose total skin electron beam therapy. • LD (12 Gy) TSEBT will be initiated on Cycle 1 Day 2 (± 2 days) of mogamulizumab over 2 to 3 week period per standard of care (SOC), as tolerated. Mogamulizumab (1 mg/kg) will be administered over 60 minutes as follows (per SOC and FDA approved use in MF and SS): * Cycle 1 only: Days1; 8; 15; and 22 (± 2 days) * Cycle 2 and beyond: Day 1 and Day 15 (± 3 days)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mogamulizumab

2016

Completed Phase 2

~70

0 / 12Eligibility criteria met