Mogamulizumab for refractory, primary Cutaneous T-Cell Non-Hodgkin Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
refractory, primary Cutaneous T-Cell Non-Hodgkin Lymphoma+11 More
Mogamulizumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of natural killer cells and mogamulizumab may be effective in treating patients with cutaneous T-cell lymphoma or adult T-cell leukemia

See full description

Eligible Conditions

  • refractory, primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Refractory Adult T-Cell Leukemia/Lymphoma
  • Recurrent Adult T-Cell Leukemia/Lymphoma
  • Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for refractory, primary Cutaneous T-Cell Non-Hodgkin Lymphoma

Study Objectives

This trial is evaluating whether Mogamulizumab will improve 1 primary outcome and 6 secondary outcomes in patients with refractory, primary Cutaneous T-Cell Non-Hodgkin Lymphoma. Measurement will happen over the course of Baseline to day 84.

Baseline to day 84
Analysis of cytokine levels
Natural Killer (NK)-cell numerical expansion in vivo
Quality of life analysis
Year 2
Progression free survival
Year 2
Overall survival
Up to 4 months
Overall response rate (ORR)
Up to day 84
Incidence of adverse events

Trial Safety

Safety Progress

1 of 3

Other trials for refractory, primary Cutaneous T-Cell Non-Hodgkin Lymphoma

Trial Design

1 Treatment Group

Treatment (mogamulizumab, chemotherapy, NK cells)
1 of 1
Experimental Treatment

This trial requires 12 total participants across 1 different treatment group

This trial involves a single treatment. Mogamulizumab 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 1 and are in the first stage of evaluation with people.

Treatment (mogamulizumab, chemotherapy, NK cells)Patients receive mogamulizumab IV over 60 minutes on day -7 and fludarabine IV and cyclophosphamide IV on days -5 to -3. Patients receive NK cell infusion on day 0. Patients then receive mogamulizumab IV over 60 minutes on days 0, 7, 14, and 28, then every 2 weeks thereafter in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Mogamulizumab
FDA approved
Fludarabine
FDA approved
Natural Killer Cell
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from start of study treatment to date of death due to any cause. in the absence of confirmation of death, survival time will be censored at the last date the patient is known to be alive, whichever comes first, assessed up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from start of study treatment to date of death due to any cause. in the absence of confirmation of death, survival time will be censored at the last date the patient is known to be alive, whichever comes first, assessed up to 2 years for reporting.

Closest Location

Ohio State University Comprehensive Cancer Center - Columbus, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for refractory, primary Cutaneous T-Cell Non-Hodgkin Lymphoma or one of the other 11 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Able to understand and voluntarily sign an informed consent form
Age >= 18 years at the time of signing the informed consent form
Able to adhere to the study visit schedule and other protocol requirements
Biopsy-proven, measurable, stage IB-IVB relapsed or refractory cutaneous T-cell lymphoma after 1 prior line of systemic therapy
Note: extracorporeal photopheresis will be considered a systemic therapy for this study
Patients with large cell transformation of cutaneous T cell lymphoma are eligible
Patients with adult T-cell leukemia/lymphoma (ATLL) of any stage and any subtypes. Patient must have had at least one standard chemotherapy and measurable disease at the time of enrollment
Patients who relapsed after autologous or allogeneic stem cell transplant are eligible
All cancer therapy, including radiation, topical steroid, and chemotherapy must have been discontinued at least 1 week or 3 half-lives whichever is the longest prior to treatment in this study. The only exceptions are participants who are symptomatic from their skin lesions and have been on corticosteroids for prolonged periods of time (> 60 days) without change. These patients may continue use of either systemic steroids (equivalent to < 10 mg per day of prednisone) or topical steroids if the frequency and dosage steroids has not changed for 21 days prior to the study. These participants should continue on the same dose of systemic/topical steroid throughout the study period unless they achieve a complete response at which time steroids can be tapered or discontinued. Patients are allowed to continue any medications with known activity in T cell lymphomas at the pre-enrollment doses for conditions other than T cell lymphomas (ie, steroids for sarcoidosis), as long as there is evidence of T cell lymphoma progression while patients were on these agents
Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 at study entry

Patient Q&A Section

How many people get granulomatous slack skin a year in the United States?

"Granulomatous slack skin affects approximately 1 in 600 people. It usually occurs on and around the thighs and buttocks and tends to be associated with diabetes. The presence of granulomatous slack skin is associated with a significantly higher risk of developing skin cancer." - Anonymous Online Contributor

Unverified Answer

Can granulomatous slack skin be cured?

"Granulomatous slack skin is a disorder in which a variety of treatment approaches have been used, with only one proven successful treatment—dexamethasone combined with other medications. We discuss this case in this report along with three others." - Anonymous Online Contributor

Unverified Answer

What is granulomatous slack skin?

"GSS is a monomorphic condition that can often be diagnosed by clinical examination. This is not surprising as the clinical feature of this condition is usually absent." - Anonymous Online Contributor

Unverified Answer

What causes granulomatous slack skin?

"It appears that granulomatous slack skin may be the result of an allergic response to a fungal or atopic agent which may be present in grain from maize, rice and wheat, or alternatively, this condition may be an allergic reaction to a food or substance (possibly flour). Treatment may be topical application of corticosteroidal creams. Further studies are required to investigate this, especially in southern parts of the continent." - Anonymous Online Contributor

Unverified Answer

What are the signs of granulomatous slack skin?

"It is necessary to be aware of the most relevant signs of SLGS. In fact, even in cases where patients are asymptomatic, the disease can be associated with changes in appearance of the skin caused by the infiltration of macrophages and lymphocytes." - Anonymous Online Contributor

Unverified Answer

What are common treatments for granulomatous slack skin?

"No randomized controlled trials or systematic reviews have been found to directly compare the effectiveness of the current treatment options for GSHS. We offer suggestions to the clinician or patient on treatments to attempt first in managing this disorder." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for granulomatous slack skin?

"The prognosis of GSKS is related to severity and location of the condition and to the patient's overall health and condition. GSKS is a difficult disease to treat as there is frequently recurrence of symptoms. It may recur multiple times in a single patient. However, the prognosis remains satisfactory and should not be discouraged. GSKS remains a disease that can be treated successfully with medications and, rarely, laser photocoagulation. Most patients with GSKS obtain symptomatic resolution. A minority of patients may choose to undergo excision and may do well. Although it has been shown to not significantly affect survival, the overall survival is poorer in patients with GSKS compared with patients without GSKS." - Anonymous Online Contributor

Unverified Answer

How does mogamulizumab work?

"Mogamulizumab is an effective treatment for recalcitrant sclerosing skin diseases including granulomatous slack skin as well as pemphigus, pemphigoid, bullous pemphigoid, dermatitis herpetiformis, pemphigus foliaceus, eczema herpeticum, and dermatomyositis. It can also be used to treat pemphigus vulgaris and cutaneous lupus erythematosus in combination with glucocorticoids or immunosuppressive drugs." - Anonymous Online Contributor

Unverified Answer

How serious can granulomatous slack skin be?

"The severity of GSKS is not limited to the extent of the disease. In addition to large lesions, this disorder can present with extensive atrophy or deformity. The treatment decisions in patients with GSKS depend on the extent and severity of atrophy and deformity." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of mogamulizumab?

"Mogamulizumab can induce various kinds of common side effects such as rash, conjunctive irritation, facial swelling, alopecia, muscle pain and abdominal discomfort. A few case reports have mentioned the associations between mogamulizumab and severe cardiotoxicity, which necessitates discontinuation." - Anonymous Online Contributor

Unverified Answer

Does mogamulizumab improve quality of life for those with granulomatous slack skin?

"Mogamulizumab treatment was well tolerated for this study population. The use of mogamulizumab increased the quality of life in patients with granulomatous slack skin which was associated with the clinical improvement in patients." - Anonymous Online Contributor

Unverified Answer

Is mogamulizumab safe for people?

"This is the first prospective analysis of mogamulizumab's safety and tolerability in people with active Crohn's disease. Results from a recent clinical trial add to clinical data from clinical trials in people with Crohn's disease and demonstrate the utility of prospective, observational, and population-based studies for assessing adverse events and drug discontinuation." - Anonymous Online Contributor

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