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Monoclonal Antibodies

Mogamulizumab + Brentuximab Vedotin for Mycosis Fungoides

Phase 1
Recruiting
Led By Amit Mehta, M.D.
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cardiac: LVEF >40%
Men or women >18 years with pathologically confirmed diagnosis of Sezary Syndrome or Mycosis fungoides
Must not have
History of solid organ transplant
History of a second malignancy, excluding non-melanoma skin cell cancer within past 2 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the safety and tolerability of combining two drugs to see what dose is safe and effective.

Who is the study for?
Adults over 18 with certain types of skin lymphoma (Sezary Syndrome or Mycosis fungoides) who've had at least one systemic therapy can join. They should have a life expectancy of more than 4 months, no severe chronic diseases, and be able to follow the study plan. Pregnant women, those with recent serious heart issues, uncontrolled infections or diabetes cannot participate.
What is being tested?
The trial is testing a combination of two drugs: Brentuximab vedotin and Mogamulizumab for skin lymphomas like CTCL and Mycosis Fungoides. It's an early-phase study focusing on finding the safest dose levels for future research.
What are the potential side effects?
Possible side effects include allergic reactions to the drugs, nerve damage symptoms like numbness or tingling, fatigue, infection risk increase due to immune system effects, liver function changes, and potential heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart's pumping ability is above 40%.
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I am over 18 and have been diagnosed with Sezary Syndrome or Mycosis fungoides.
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I am not pregnant or breastfeeding, and I have a negative pregnancy test if applicable.
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I have had at least one systemic treatment for my condition, not just treatments applied to the skin.
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My kidney function is good, with a GFR over 40.
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I don't have chronic graft versus host disease needing systemic treatment.
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I can take care of myself and perform daily activities.
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My recent biopsy shows more than 1% CD30 positivity.
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I finished my cancer treatment at least a week ago, or longer depending on the treatment type.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a solid organ transplant.
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I have had cancer other than non-melanoma skin cancer in the last 2 years.
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I have moderate to severe numbness, tingling, or muscle weakness.
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My cutaneous T-cell lymphoma affects my brain or spinal cord.
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I am HIV positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rates of Adverse Events
Rates of Serious Adverse Events
Secondary study objectives
Duration of Response
Overall Response rate

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: CohortExperimental Treatment2 Interventions
Fixed dose of Mogamulizumab and dose de-escalation with Brentuximab Vedotin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab vedotin
2012
Completed Phase 4
~210
Mogamulizumab
2016
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Kyowa Kirin China Pharmaceutical Co., Ltd.Industry Sponsor
39 Previous Clinical Trials
6,320 Total Patients Enrolled
Seagen Inc.Industry Sponsor
210 Previous Clinical Trials
74,328 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,365 Total Patients Enrolled
Kyowa Kirin, Inc.Industry Sponsor
48 Previous Clinical Trials
5,735 Total Patients Enrolled
Amit Mehta, M.D.Principal InvestigatorUniversity of Alabama at Birmingham

Media Library

Cutaneous T-Cell Lymphoma Research Study Groups: Cohort
~5 spots leftby Apr 2026
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