Mogamulizumab for Mycosis Fungoides
This study is evaluating whether a combination of drugs can treat people with ATLL or MF/SS.
See full descriptionAbout the trial for Mycosis Fungoides
Treatment Groups
This trial involves 2 different treatments. Mogamulizumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Mycosis Fungoides or one of the other 7 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Mogamulizumab will improve 3 primary outcomes, 6 secondary outcomes, and 2 other outcomes in patients with Mycosis Fungoides. Measurement will happen over the course of 6 cycles.
Who is running the study
Principal InvestigatorPatient Q & A Section
What is mycosis fungoides?
The majority of reported cases of mycosis fungoides involved the head and neck region. It was more common in young women and adolescents and had an overall good prognosis. A diagnosis of mycosis fungoides is frequently suspected based on the appearance of the lesions which may resemble those seen in other skin cancers. In many cases however, a biopsy is required to establish a diagnosis.
What are common treatments for mycosis fungoides?
Most of the treatments are similar between studies. We found no difference in outcome from clinical trials of radiotherapy, alkylating agents, and antimetabolites in this patient population. Randomized Phase III trials of newer agents with better tolerability may yield new insights into therapeutic modalities for this form of cancer.
How many people get mycosis fungoides a year in the United States?
This group of patients is fairly new (since 1990) and will continue to evolve. The data may not necessarily represent the current or future characteristics of the population.
What causes mycosis fungoides?
A probable cause of mycosis fungoides is the interaction of a virus or a carcinogenic parasite with individuals who are already immunodeficient. An unidentified virus or a malignant neoplasm may also play a role.
Can mycosis fungoides be cured?
With the use of combination chemotherapy, mycosis fungoides can be treated and often responds to therapy. However, many patients progress to lymphoma, which can be very difficult to treat at this stage. The most effective treatment in lymphoma consists of a combination of multiple chemotherapy regimens. A study that assessed the rate of disease control or remission with single-agent chemotherapy was inconclusive.
What are the signs of mycosis fungoides?
The signs of MF can be divided into three distinct groups, depending on the degree of monoclonal antibody binding to CD30 and CD10 and on the stage of disease. These groups are: T-cell monoclonal gammopathy of undetermined significance or T-cell Ig+ monoclonal gammopathy of undetermined significance, anaplastic large-cell lymphoma and mycosis fungoides. A single clinical finding cannot reliably predict which group of patients the patient is in.
What are the common side effects of mogamulizumab?
Mogamulizumab is associated with clinically significant reactions that can be severe. It is not surprising that these side effects are greater in the setting of a cancer treatment.
Does mogamulizumab improve quality of life for those with mycosis fungoides?
mogamulizumab decreases disease activity and improves HRQoL in patients with MF. MOGAb is effective in reducing both physical and mental components of HRQoL in patients with MF. summary: Data from a recent study is evaluating the use of mogamulizumab in patients with mycosis fungoides.
What are the chances of developing mycosis fungoides?
The chances of developing MF are increased with an increase in the absolute number of years since exposure to ultraviolet radiation, as well as increasing exposure to sun due to increasing exposure time during childhood, teenage, and adult years. Exposure to solar radiation on the skin can cause the immune system to generate an overreactive and aberrant T-cell response. If an individual inherits the abnormal genes responsible for this overreactive and aberrant T-cell response from either the paternal or maternal line, then in children this overactive and aberrant response will be expressed and the T-cell proliferation response will cause a development of the overactive and aberrant and reactive T-cell response.
Does mycosis fungoides run in families?
Results from a recent paper shows that there are few familial cases of MF which could be because mycosis fungoides runs in families more often than mycosis fungoides is sporadic. Alternatively there could be a higher percentage of familial cases of other cutaneous T cell lymphomas which are also autosomal dominantly transmitted. Either way, more studies are needed to further assess the genetic predisposition of mycosis fungoides and other related skin tumours.
Who should consider clinical trials for mycosis fungoides?
With proper management, mycotic patients can have a good quality of life. With proper management, it should not be difficult if not impossible to stop mycotic disease progression to the lymphoid phase even with aggressive therapy and then go into remission or be stable indefinitely. Clinically trials should be undertaken by people with this disease that are able to think objectively, have a clear plan of what they want to lose, are able to be self-determining and who should participate in clinical trials for mycosis fungoides.
What is the primary cause of mycosis fungoides?
The majority of patients have [a first-degree relative with a mycosis fungoides-like condition]. There is no specific [hepatitis C virus] risk factor in these primary MF patients although [hepatitis B virus] is more frequent in younger patients (median age 56 yr ys).