CLINICAL TRIAL

Mogamulizumab for Mycosis Fungoides

Waitlist Available · 18+ · All Sexes · Bethesda, MD

This study is evaluating whether a combination of drugs can treat people with ATLL or MF/SS.

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About the trial for Mycosis Fungoides

Eligible Conditions
Mycoses · Leukemia · Leukemia, T-Cell · Leukemia-Lymphoma, Adult T-Cell · Syndrome · Adult T-Cell Lymphoma/Leukemia · Sezary Syndrome · 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.

Experimental Group 1
Recombinant human Interleukin-15 (rhIL-15)
DRUG
+
rhIL-15
DRUG
+
Mogamulizumab
BIOLOGICAL
Experimental Group 2
Recombinant human Interleukin-15 (rhIL-15)
DRUG
+
rhIL-15
DRUG
+
Mogamulizumab
BIOLOGICAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mogamulizumab
FDA approved

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A formalin fixed tissue block or 15 slides of tumor sample (archival or fresh) must be available for performance of correlative studies. NOTE: Patients must be willing to have a tumor biopsy if prior tissue or adequate archival tissue is not available (i.e., post- enrollment and prior to treatment).
Age >18 years
NOTE: Because no dosing or adverse event data are currently available on the use of rhIL-15 in combination with mogamulizumab in patients <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 (Karnofsky greater than or equal to 80%
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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 one year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to one year.
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 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.

Overall response rate
6 CYCLES
The response rate will be determined and reported along with a 95% confidence interval.
Number of Participants With a Dose-limiting Toxicity (DLT) Possibly, Probably or Definitely Related to Interleukin 15 (IL-15) or Mogamulizumab.
FIRST CYCLE OF TREATMENT (28 DAYS)
A DLT is defined as any grade 3 (severe), 4 (life-threatening), or 5 (death related to adverse event) toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably or definitely related to IL-15 or mogamulizumab.
Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin 15 (IL-15) (rhIL-15)
28 DAYS
The MTD is the dose level at which no more than 1 of up to 6 patients experience DLT during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) patients have DLT. A dose-limiting toxicity (DLT) is defined as: any grade 3, 4, or 5 toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably or definitely related to IL-15 or mogamulizumab.
Maximum tolerated dose (MTD)
28 DAYS
Frequency (number and percentage) of treatment emergent adverse events
Number of Participants Overall Response
6 CYCLES (ONE CYCLE IS 28 DAYS)
Overall response was assessed by the Response Criteria for Adult T-cell Leukemia-Lymphoma. The response rate was determined and reported along with a 95% confidence interval. Complete Response (CR) is disappearance of all disease. Unconfirmed Complete Response (CRu) is stable residual mass in bulky lesion. Partial Response (PR) is regression of disease. Relapsed Disease (RD)/Progressive Disease (PD) is new or increased lesions. And Stable Disease (SD) is failure to attain CR/PR and no PD.
Number of Grade 1-4 Treatment Related Adverse Events
DATE TREATMENT CONSENT SIGNED TO DATE OFF STUDY, APPROXIMATELY 5 MONTHS AND 25 DAYS FOR DOSE LEVEL 1, AND 4 MONTHS AND 14 DAYS FOR DOSE LEVEL 2.
Adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. And Grade 5 is death related to adverse event.
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Who is running the study

Principal Investigator
K. C.
Kevin Conlon, MD
National Cancer Institute (NCI)

Patient Q & A Section

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

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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).

Anonymous Patient Answer
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