CLINICAL TRIAL

Quality-of-Life Assessment for Mycoses

Recruiting · 18+ · All Sexes · Duarte, CA

This study is evaluating whether extracorporeal photopheresis and mogamulizumab might work together to treat patients with erythrodermic cutaneous T cell lymphoma.

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About the trial for Mycoses

Eligible Conditions
Mycoses · Lymphoma, T-Cell · Lymphoma · Primary Cutaneous T-Cell Non-Hodgkin Lymphoma · Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8 · Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 · Sezary Syndrome · Mycosis Fungoides · Lymphoma, T-Cell, Cutaneous · Syndrome · Folliculotropic Mycosis Fungoides · Transformed Mycosis Fungoides · Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8 · Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8

Treatment Groups

This trial involves 2 different treatments. Quality-of-Life Assessment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Questionnaire Administration
OTHER
Quality-of-Life Assessment
OTHER
Extracorporeal Photopheresis
PROCEDURE
Mogamulizumab
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Extracorporeal Photopheresis
2004
Completed Phase 2
~30
Mogamulizumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
If the study principal investigator is unavailable, exceptions may be granted with study principal investigator (PI) approval. show original
The TNMB classification was originally designed to stage cancer show original
Age: >= 18 years
The Eastern Cooperative Oncology Group (ECOG) has a rating system for the severity of cancer show original
If it is appropriate, we will get your agreement by following the institutional guidelines. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 1 year post treatment
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 1 year post treatment.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Quality-of-Life Assessment will improve 1 primary outcome and 6 secondary outcomes in patients with Mycoses. Measurement will happen over the course of Up to 30 days post treatment.

Incidence of adverse events
UP TO 30 DAYS POST TREATMENT
Toxicity and adverse events will be recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events 5.0 scale. Observed toxicities will be summarized by type, severity, date of onset, and attribution.
Progression-free survival
FROM INITIATION OF STUDY THERAPY TO THE FIRST OBSERVATION OF DISEASE RELAPSE/PROGRESSION OR DEATH FROM ANY CAUSE, WHICHEVER OCCURS FIRST, ASSESSED UP TO 1 YEAR
Will be estimated using the product-limit method of Kaplan and Meier.
Duration of response
FROM THE FIRST ACHIEVEMENT OF PR OR CR TO TIME OF PARTIAL DISEASE OR DEATH, ASSESSED UP TO 1 YEAR
Will be estimated using the product-limit method of Kaplan and Meier.
Time to response
FROM INITIATION OF STUDY THERAPY TO THE FIRST ACHIEVEMENT OF CR OR PR, ASSESSED UP TO 1 YEAR
Will be estimated using the product-limit method of Kaplan and Meier.
Overall survival
FROM INITIATION OF STUDY THERAPY TO DEATH FROM ANY CAUSE, ASSESSED UP TO 1 YEAR
Will be estimated using the product-limit method of Kaplan and Meier.
Complete response rate
UP TO 1 YEAR POST TREATMENT
Defined as the proportion of response-evaluable patients that have a documented CR.
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Patient Q & A Section

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

Can mycoses be cured?

Mycoses appear to be more difficult to cure than other bacterial infections. There are no effective treatments available for many kinds of fungal infections. A few medications may help some types of infection but their effectiveness has not yet been adequately tested. You can find the latest medical research by using Power, which allows you to search studies tailored to your condition, location, and ideal treatment.

Anonymous Patient Answer

Is quality-of-life assessment typically used in combination with any other treatments?

Although the results from this study were intriguing, they need to be interpreted cautiously due to the small sample size. Future work needs to examine the use of QOL in combination with other treatment options in order to improve the effectiveness of therapeutic interventions in patients with ATCM.

Anonymous Patient Answer

What are common treatments for mycoses?

Unfortunately, there are very few randomized controlled trials evaluating treatments for fungal infections, so many treatments have been tested only in small trials. A 2012 review found that fluconazole was effective against all types of "Candida" infections but topical antifungal creams were less effective than oral therapies and amphotericin B was not recommended for managing invasive candidiasis. It also found that more research is needed on topical azoles and echinocandins as well as new agents such as liposomes, nanoparticles, and vaccines. A similar review published in 2015 found that azoles were superior to (and safer than) amphotericin B in treating both superficial and deep "Candida" infections.

Anonymous Patient Answer

How serious can mycoses be?

Infections caused by fungi are very common; however, they represent only a small percentage of all infections. They are often underestimated because many physicians consider fungal infections (such as blastomycosis) to be benign diseases. Blastomycosis and coccidioidomycosis are potentially fatal, and this is one reason why we should pay close attention to these organisms whenever they are encountered. The need for early diagnosis and treatment also makes it important for physicians to be aware of fungal infections. Fungi can be acquired from contaminated soil or water sources, and some can become opportunistic pathogens after old age. Most people with thrush are unaware that their symptoms are attributable to an underlying fungal infection.

Anonymous Patient Answer

What is the average age someone gets mycoses?

The majority of people who get mycoses don't develop them until their 50s and 60s or more. However, even though most people seek medical attention when they get them, many people also don't do much about them. We need to educate patients and caregivers alike about what to look for when they notice something odd about themselves. And we need to make sure our hospitals and doctors take this into account when prescribing medications for the treatment of skin conditions like mycoses.

Anonymous Patient Answer

What is the latest research for mycoses?

There have been numerous advances in our knowledge of the pathogenesis of fungal infections, especially those caused by Aspergillus, Cryptococcus, Histoplasma, and Candida species. Available evidence suggests that antifungal drugs may be effective against these infections. However, there are limited clinical data on the effectiveness of antifungal agents in treating infections. Further research is needed to determine the best way to treat fungal infections. Clinical Trial Registry Number: NCT01853772 (https://clinicaltrials.gov/ct2/show/NCT01853772/?).

Anonymous Patient Answer

What is mycoses?

Mycoses may be diverse in presentation and cause, but commonly involve fungi that grow fast, cause disease in humans, and thrive in warm climates. A new approach to fungal infections will likely arise if we utilize our knowledge of pathogenesis and human genetics to better understand these diseases.\n

Anonymous Patient Answer

Who should consider clinical trials for mycoses?

The key factors for deciding whether to consider a drug for use in a clinical trial include the seriousness of the disease, the cost of the drug, how long a patient will be treated, the proportion of patients who respond to the drug, and the likelihood that the response is durable. Patients at high risk of a particular mycosis should not delay treatment if they do not see any benefit.

Anonymous Patient Answer

Does mycoses run in families?

In the majority of reported cases of IFI, there was no evidence of any clustering of infection within families. Furthermore, only one case report describes family history, suggesting that IAFI is not a hereditary disease. Thus, routine genetic testing is probably unnecessary. Nevertheless, if family history is present, the diagnosis of IAFI should be considered in patients presenting with similar symptoms.

Anonymous Patient Answer

What does quality-of-life assessment usually treat?

The majority of studies on QOL assessments do not contain detailed information about treatment and quality of life before and following treatment. It is important to report treatment, such as medications, related to both outcomes and completeness of reporting.

Anonymous Patient Answer

What causes mycoses?

Iatrogenic infections are rare; however, patients who do develop an infection tend to have other risk factors for developing the infection. In the setting of the ICU, it is important to consider drug-induced infections in patients treated with antibiotics. In addition, fungal infections may be underrecognized, particularly in the critically ill patient.

Anonymous Patient Answer
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