Study on Extracorporeal Photopheresis and Mogamulizumab for Treating Erythrodermic Cutaneous T Cell Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04930653

Provider View

This clinical trial is exploring a combination of treatments, extracorporeal photopheresis (ECP) and mogamulizumab, to see if they can effectively treat erythrodermic cutaneous T cell lymphoma (CTCL), a rare type of skin cancer. The study aims to determine if these treatments can work together to kill cancer cells and boost the immune system's response.

Patient Parameters

Program Overview

This study is testing a new treatment approach for erythrodermic cutaneous T cell lymphoma (CTCL), a rare skin cancer that starts in T cells, a type of white blood cell. The condition often causes a widespread red rash. The treatment involves two parts: extracorporeal photopheresis (ECP), which is a process where blood is treated with ultraviolet light and returned to the body, and mogamulizumab, a drug that may help stop cancer cells from growing. The goal is to see if combining these treatments can effectively target and kill cancer cells while also enhancing the body's immune response.

Description

The main goal of this study is to see how well the combination of extracorporeal photopheresis (ECP) and mogamulizumab works in patients with erythrodermic cutaneous T cell lymphoma (CTCL) who have not been treated with mogamulizumab before. Researchers will look at how well patients tolerate the treatment and how effective it is in reducing cancer symptoms.

Secondary goals include measuring how long it takes for the treatment to work, how long the effects last, and how it impacts patients' survival without the cancer getting worse. The study will also track any side effects experienced by patients.

Exploratory goals involve assessing patients' quality of life before, during, and after treatment, and examining how the treatment affects the cancer environment in the skin and blood.

Patients will receive mogamulizumab through an IV on specific days of each treatment cycle. Starting in the second cycle, they will also undergo ECP on certain days. Treatment cycles repeat every 28 days for up to 6 cycles, and patients who respond well may receive up to 6 additional cycles. After completing the treatment, patients will have follow-up visits for up to 12 months.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Must agree to allow the use of previous tumor biopsy samples.
  • Must be 18 years or older.
  • Must have a performance status score of 0 to 2, indicating they are fully active or have some limitations but are still able to care for themselves.
  • Must have a confirmed diagnosis of mycosis fungoides (MF) or Sezary syndrome (SS), specific types of CTCL.
  • Must have measurable disease based on specific assessment tools.
  • Must have a recent skin biopsy available for review.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Must not have active hepatitis B or C infections.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 3 months after the last treatment dose.

Exclusion Criteria

  • Previous treatment with mogamulizumab.
  • Recent treatment with systemic therapies, including chemotherapy, radiation, or immunotherapy.
  • Recent use of skin-directed therapies or immunosuppressive medications.
  • Recent vaccination with live, attenuated vaccines.
  • Active infections requiring antibiotics.
  • Known hepatitis B or C infections.
  • Other active cancers.
  • Pregnant or breastfeeding women.
  • History of stem cell transplantation.
  • Conditions requiring chronic steroid or immunosuppressive treatment.
  • Severe heart disease or recent heart attack.
  • Recent major surgery.
  • Active autoimmune or inflammatory disorders requiring treatment in the past 3 years.
  • History of primary immunodeficiency.
  • Any condition that may interfere with the patient's ability to participate in the study.

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