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Monoclonal Antibodies

POTELIGEO & Phototherapy combination therapy for Mycosis Fungoides (PLIGHT Trial)

Q: What is the upper threshold for the number of individuals enrolled in this medical study?

<p>Indeed, as indicated on clinicaltrials.gov, this trial is actively seeking eligible participants. The study was originally posted on February 1st, 2024 and recently updated on January 23rd, 2024. The research team aims to recruit a total of 20 patients from a single site.</p>

Q: Are there any available openings for patients to participate in this study?

<p>Indeed, the details on clinicaltrials.gov affirm that this study is actively searching for eligible participants. The trial was initially published on February 1st, 2024 and underwent its most recent revision on January 23rd, 2024. The research team aims to recruit a total of 20 individuals from one location.</p>

Phase < 1

Recruiting

Led By Lubomir Sokol, MD, PhD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Female of childbearing potential (FCBP) must have a negative pregnancy test within 7 days of receiving study medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

PLIGHT Trial Summary

This trial is testing the use of phototherapy and a drug called POTELIGEO for the treatment of early-stage mycosis fungoides. It is a small study being conducted at one center

Who is the study for?

This trial is for adults with early-stage mycosis fungoides, a type of skin lymphoma. Participants must have had stable disease or some response to previous phototherapy and can't have had major surgery or certain treatments recently. They should not have severe illnesses, other cancers within the last 2 years (with exceptions), active infections like HIV or hepatitis, known allergies to study drugs, or be pregnant.Check my eligibility

What is being tested?

The PLIGHT study tests combining phototherapy with an immunotherapy drug called Mogamulizumab in patients with early-stage mycosis fungoides. It's an open-label pilot study where all participants receive both treatments concurrently at a single center.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system such as rash and itching due to phototherapy; infusion-related reactions from Mogamulizumab; fatigue; blood disorders; increased risk of infections; and potential worsening of autoimmune diseases.

PLIGHT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am a woman who can have children and have a recent negative pregnancy test.

Select...

My CTCL is in early stages and tests show specific gene changes in my blood.

Select...

I am 18 years old or older.

Select...

I have been diagnosed with mycosis fungoides based on tests and clinical exams.

Select...

All side effects from my previous cancer treatments are mild.

PLIGHT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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

Secondary outcome measures

CD4+CD26- and CD4+CD7 Change

Duration of skin response for responding subjects

Pruritus Change

+2 more

PLIGHT Trial Design

1Treatment groups

Experimental Treatment

Group I: POTELIGEO & Phototherapy combination therapyExperimental Treatment2 Interventions

POTELIGEO (mogamulizumab-kpkc) will be given according to FDA approved dose and scheduled for 8 cycles. After 2 cycles of POTELIGEO, all subjects will start phototherapy as combination therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Phototherapy

2021

Completed Phase 4

~750

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,462 Total Patients Enrolled

1 Trials studying Mycosis Fungoides

162 Patients Enrolled for Mycosis Fungoides

Kyowa Hakko Kirin Pharma, Inc.Industry Sponsor

22 Previous Clinical Trials

1,536 Total Patients Enrolled

Lubomir Sokol, MD, PhDPrincipal InvestigatorMoffitt Cancer Center

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

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

What is the upper threshold for the number of individuals enrolled in this medical study?

"Indeed, as indicated on clinicaltrials.gov, this trial is actively seeking eligible participants. The study was originally posted on February 1st, 2024 and recently updated on January 23rd, 2024. The research team aims to recruit a total of 20 patients from a single site."

Answered by AI

Are there any available openings for patients to participate in this study?

"Indeed, the details on clinicaltrials.gov affirm that this study is actively searching for eligible participants. The trial was initially published on February 1st, 2024 and underwent its most recent revision on January 23rd, 2024. The research team aims to recruit a total of 20 individuals from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phototherapy and Mogamulizumab in Early Stage MF (PLIGHT)

2024. "Phototherapy and Mogamulizumab in Early Stage MF (PLIGHT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06235281.

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