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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rates of Adverse Events

Rates of Serious Adverse Events

Secondary outcome measures

Duration of Response

Overall Response rate

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 2

~200

Mogamulizumab

2016

Completed Phase 2

~70

0 / 9Eligibility criteria met

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

208 Previous Clinical Trials

74,218 Total Patients Enrolled

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,652 Total Patients Enrolled

Media Library

Cutaneous T-Cell Lymphoma Research Study Groups: Cohort

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Cohort protocol been granted authorization by the Food and Drug Administration?

"Due to the limited evidence of Cohort's efficacy and safety, our team at Power placed it on a scale from 1 to 3 with one being the lowest."

Answered by AI

What is the aggregate figure for enrollees in this trial?

"Affirmative. Records on clinicaltrials.gov demonstrate that this research, which was posted to the site on May 1st 2023, is actively looking for participants. The trial aims to recruit 10 individuals from a single medical centre."

Answered by AI

Are researchers still enrolling participants for this clinical trial?

"Indeed, the information on clinicaltrials.gov reveals that this trial is actively recruiting participants. Initially posted on May 1st 2023 and last edited on May 26th of the same year, 10 patients are required at a single site for this research study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides

Amitkumar Mehta, MD 2023. "Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05414500.

All > Mycosis Fungoides