What side effects are associated with this type of intervention?

Common treatments for Cutaneous T-Cell Lymphoma (CTCL) include systemic therapies such as monoclonal antibodies, chemotherapy, and immunomodulatory drugs. Mogamulizumab, an anti-CCR4 monoclonal antibody, is associated with side effects such as infusion reactions, skin rash, and infections. Other similar treatments, like brentuximab vedotin, can cause peripheral neuropathy, fatigue, and gastrointestinal issues. Chemotherapy agents often lead to myelosuppression, nausea, and hair loss. Immunomodulatory drugs may result in flu-like symptoms, fatigue, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for Cutaneous T-Cell Lymphoma (CTCL), including monoclonal antibodies and other targeted therapies. Mogamulizumab, an anti-CCR4 monoclonal antibody, is one such treatment under investigation. Other FDA-approved monoclonal antibodies for CTCL include brentuximab vedotin, which targets CD30. Additionally, the FDA has approved other therapies such as bexarotene, a retinoid, and vorinostat, a histone deacetylase inhibitor, for the treatment of CTCL. These treatments aim to target specific pathways involved in the proliferation of malignant T-cells.

What other types of research exist?

Promising novel alternatives to Mogamulizumab for CTCL patients include Brentuximab Vedotin (an anti-CD30 antibody-drug conjugate), Pembrolizumab (an anti-PD-1 monoclonal antibody), and Chimeric Antigen Receptor (CAR) T-cell therapies targeting specific antigens on CTCL cells. These therapies have shown efficacy in clinical trials and represent potential treatment options for CTCL patients in 2024.

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Monoclonal Antibodies

Mogamulizumab for Cutaneous T-Cell Lymphoma

Phase 2

Waitlist Available

Research Sponsored by Kyowa Kirin, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stage IB, II-A, II-B, III, or IV;Participants who have failed at least one prior course of systemic therapy (e.g., interferon, bexarotene, photopheresis, anti-neoplastic chemotherapy). Psoralen plus ultraviolet light therapy (PUVA) is not considered a systemic therapy.

Histologically confirmed diagnosis of MF or SS

Must not have

Prior treatment with mogamulizumab;

History of allogeneic transplant.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of consent, at every treatment and follow up visit, up to 27 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called mogamulizumab in adults with certain types of skin cancer that have come back or not responded to other treatments. The medication helps the immune system find and destroy cancer cells. Mogamulizumab is approved for treating various types of skin cancer.

Who is the study for?

This trial is for adults with certain types of skin lymphoma (CTCL) who have tried at least one systemic therapy without success. It's not open to those who've had a specific cell transformation, previous mogamulizumab treatment, or an allogeneic transplant.

What is being tested?

The study tests the safety and effects of mogamulizumab given every four weeks after initial weekly doses in patients with relapsed/refractory mycosis fungoides (MF) and Sézary syndrome (SS), which are subtypes of CTCL.

What are the potential side effects?

Mogamulizumab may cause side effects such as skin reactions, infusion-related symptoms, fatigue, infections due to immune system suppression, and potentially serious allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is at a late stage and I've had at least one treatment that didn't work.

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My diagnosis of mycosis fungoides or Sézary syndrome is confirmed by tissue analysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been treated with mogamulizumab before.

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I have had a transplant from a donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of consent, at every treatment and follow up visit, up to 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of consent, at every treatment and follow up visit, up to 27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of consent, at every treatment and follow up visit, up to 27 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number, percentage and severity of treatment emergent adverse events

Side effects data

From 2023 Phase 1 & 2 trial • 8 Patients • NCT03309878

100%

Electrocardiogram QT corrected interval prolonged

100%

Fatigue

100%

Fever

100%

Anemia

100%

Anorexia

100%

Cough

100%

Hyponatremia

50%

Generalized muscle weakness

50%

Gait disturbance

50%

Presyncope

50%

Weight loss

50%

Pruritus

50%

Wheezing

50%

White blood cell count decreased

50%

Hypophosphatemia

50%

Apical ballooning

50%

Hypotension

50%

Fall

50%

Lymphocyte count decreased

50%

Hypothyroidism

50%

Infusion related reaction

50%

Rash maculopapular

50%

Right bundle branch block

50%

Sinus tachycardia

50%

Urinary frequency

50%

Vomiting

50%

Headache

50%

Hemorrhoidal hemorrhage

50%

High degree AV block

50%

Hypercalcemia

50%

Heart failure

50%

Colitis

50%

Dehydration

50%

Infusion-related reaction

50%

Ejection fraction decreased

50%

Aspartate aminotransferase increased

50%

Chills

50%

Confusion

50%

Constipation

50%

Creatinine increased

50%

Hallucinations

50%

Hypoalbuminemia

50%

Hypokalemia

50%

Nausea

50%

Neutrophil count decreased

50%

Non-cardiac chest pain

50%

Penile bleeding

50%

Polydipsia

50%

Diarrhea

50%

Dysarthia

50%

Upper respiratory infection

100%

80%

60%

40%

20%

Study treatment Arm

Phase I Dose Level 1

Phase I Dose Level -1

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MogamulizumabExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mogamulizumab

2016

Completed Phase 2

~70

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mogamulizumab, an anti-CCR4 monoclonal antibody, works by targeting the CCR4 receptor on malignant T-cells, facilitating their destruction by the immune system. This mechanism is significant for Cutaneous T-Cell Lymphoma (CTCL) patients as it represents a targeted approach, aiming to improve treatment efficacy while minimizing side effects. Such precision in targeting specific cancer cell components can lead to better outcomes and a higher quality of life for patients.

Radiation-induced dermatitis after administration of mogamulizumab for adult T-cell leukaemia/lymphoma: a multi-institutional retrospective study.