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Mogamulizumab + Extracorporeal Photopheresis for Cutaneous T-Cell Lymphoma
Phase 1 & 2
Recruiting
Led By Pamela B Allen
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newly diagnosed or =< 3 different lines of systemic therapy
Histopathologic diagnosis of primary cutaneous T-cell non-Hodgkin lymphoma (CTCL) (mycosis fungoides [MF] or Sezary syndrome [SS]), confirmed by skin biopsy, or lymph node, or blood assessment, of current disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date of 1st dose of study drug to death from any cause, assessed up to 3 years
Awards & highlights
Study Summary
This trial is testing the combination of two existing treatments, mogamulizumab and extracorporeal photopheresis, to see if they are more effective than either treatment alone in treating patients with Sezary syndrome or mycosis fungoides.
Who is the study for?
This trial is for adults with Sezary syndrome or mycosis fungoides, specific forms of cutaneous T-cell lymphoma. Participants must have a certain level of physical fitness (ECOG <=2), not more than three prior systemic therapies, and adequate organ function. Pregnant or breastfeeding women are excluded, and participants must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the combination of mogamulizumab (a drug that targets cancer cells) with extracorporeal photopheresis (ECP), a treatment involving blood processing with light exposure to kill cancer cells. The goal is to see if this combo is more effective for treating skin-affecting cancers than current methods.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, immune system-related issues due to mogamulizumab targeting proteins on T-cells, fatigue, skin irritation from ECP treatment, and potential complications related to the immune response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had 3 or fewer treatments for my condition.
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My skin cancer is confirmed as CTCL (either mycosis fungoides or Sezary syndrome).
Select...
I can take care of myself but might not be able to do heavy physical work.
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My skin lymphoma is at stage 3A-4A2.
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I have had chemotherapy before, but not low dose methotrexate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ date of 1st dose of study drug to death from any cause, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of 1st dose of study drug to death from any cause, assessed up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of dose-limiting toxicities (DLT's) (Phase Ib)
Rate of overall response lasting at least 6 months (ORR6) (Phase II)
Secondary outcome measures
Best overall response rate (ORR)
Duration of response (DOR)
Incidence of adverse events
+3 moreOther outcome measures
Changes in genomic profiles
Genomic and immunologic profiles
T cell populations will include T-regulatory cells and CD8+ cytotoxic T-cells
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (mogamulizumab, ECP)Experimental Treatment3 Interventions
INDUCTION (WEEKS 1-7): Patients receive mogamulizumab IV over 60 minutes on days 1, 8, 15, 22, and 36 in the absence of disease progression progression and unacceptable toxicity. Patients also undergo extracorporeal photopheresis on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression and unacceptable toxicity.
TREATMENT (CYCLES 1-12): Patients receive mogamulizumab IV over 60 minutes on days 1 and 15, and undergo extracorporeal photopheresis on days 1 and 15 of cycles 1-6, then day 1 of subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression and unacceptable toxicity.
MAINTENANCE (CYCLES 13+): Patients with clinical benefit may continue extracorporeal photopheresis on day 1. Cycles repeat every 28 days in the absence of disease progression and 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
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,664 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,100 Total Patients Enrolled
89 Trials studying Sezary Syndrome
3,554 Patients Enrolled for Sezary Syndrome
Pamela B AllenPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had total skin electron beam therapy in the last 6 months.I do not have serious heart conditions that need ongoing treatment.I have had 3 or fewer treatments for my condition.I have had ECP treatment but still have measurable disease.I have changed or started a new cancer treatment due to no improvement, worsening, or side effects.I haven't had a life-threatening cancer, except for certain skin cancers or localized cancers treated for cure, in the past year.My skin cancer is confirmed as CTCL (either mycosis fungoides or Sezary syndrome).I have received 2 or fewer doses of mogamulizumab before signing up.I agree to use birth control during and 30 days after the study.I have not had major surgery in the last 2 weeks.I am on medication for my whole body, which could include pills or injections.I had hepatitis C, but it's treated and cleared with no liver issues, and I've seen a liver specialist recently.My kidneys work well enough; I don't need dialysis.I haven't used topical steroids in the last 14 days.I tested positive for hepatitis B core antibody but negative for its surface antigen and DNA, with no liver issues due to hepatitis B.I am currently on medication for a serious or uncontrolled infection.My eligibility is not affected by my CCR4 expression status.I do not have an autoimmune disease that needs strong medication.I am using low dose steroids or topical steroids for a long-term skin condition.I haven't had CTCL treatment in the last 4 weeks.I am a woman who can have children and have a recent negative pregnancy test.I agree to use birth control during and 30 days after the study.I have not undergone ECP treatment for more than 2 months in the last 3 months.I have not had mogamulizumab therapy in the last 6 months or had issues with it.I am not pregnant or breastfeeding.I can take care of myself but might not be able to do heavy physical work.My skin lymphoma is at stage 3A-4A2.I have taken mogamulizumab before joining this study.I have HIV with no hepatitis, a CD4+ count over 400, undetectable viral load, and see an infectious disease specialist.I have had a transplant from another person.I have large swollen lymph nodes or advanced lymph node cancer.I have had chemotherapy before, but not low dose methotrexate.My cancer has not spread to my organs, except possibly my bone marrow.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (mogamulizumab, ECP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can you elaborate on the other explorations that have been conducted using Extracorporeal Photopheresis?
"Currently, 10 clinical trials for Extracorporeal Photopheresis are in progress. None of those studies have achieved Phase 3 status yet. Despite the base of operations being Bethesda, Maryland, 48 distinct medical centres are conducting research on this treatment modality."
Answered by AI
What is the ultimate aim of this experiment?
"The primary outcome of this study, which shall be measured over a 3-year period post treatment, is the Frequency of dose-limiting toxicities (DLT's). Secondary outcomes include Time to response based on GRS and estimated via the Kaplan Meier Method, Duration of Response calculated in the same way as well as Progression Free Survival evaluated through Cox proportional hazards models. Statistical significance will also be determined by assessing any potential interaction terms between these factors."
Answered by AI
Does this research still have open slots for individuals to join?
"Clinicaltrials.gov confirms that this experiment is actively seeking participants, having been posted on April 21st 2021 and edited as recently as June 15th 2022."
Answered by AI
What is the total number of individuals engaged in this trial?
"Affirmative. Per the clinicaltrials.gov records, this medical trial which was initially published on April 21st 2021 is still seeking applicants. 32 participants are required at a single site."
Answered by AI
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