Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma

Recruiting now · Phase 2

Conditions studied: Folliculotropic Mycosis Fungoides, Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Sezary Syndrome, Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8, Transformed Mycosis Fungoides

In brief

This phase II trial studies the effect of extracorporeal photopheresis (ECP) and mogamulizumab in treating patients with erythrodermic cutaneous T cell lymphoma (CTCL), a type of skin lymphoma. CTCL is a rare type of cancer that begins in the white blood cells called T cells. Erythrodermic is a widespread red rash that may cover most of the body. ECP is a medical treatment that removes blood with a machine, isolates white blood cells and exposes them to ultra violet light, then returns the cells to the body. Mogamulizumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving mogamulizumab with ECP may work together to kill the tumor cells directly (with mogamulizumab) and boost immune response to cancer (with ECP).

Key facts

Study ID: NCT04930653
Run by: City of Hope Medical Center
People needed: 34
Starts: 2022-10-19
Expected to finish: 2028-06-15
Last updated by the study team: 2025-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guideline
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Age: >= 18 years
Eastern Cooperative Oncology Group (ECOG) =< 2
Histologically confirmed mycosis fungoides (MF) or Sezary syndrome (SS). Safety lead-in: >= stage IIB OR >= stage IB-IIA folliculotropic/transformed MF. Phase 2: >= stage IB
Stage of disease according to Tumor-Node-Metastasis-Blood (TNMB) classification
Pathology report must be diagnostic or be consistent with MF/SS criteria
SS is defined as meeting T4 plus B2 criteria; where the biopsy of erythrodermic skin may only reveal suggestive but not diagnostic histopathologic features, the diagnosis may be based on either node biopsy or fulfillment of B2 criteria
For MF where the histological diagnosis by light microscopic examination is not confirmed, diagnostic criteria that been recommended by the International Society of Cutaneous Lymphomas (ISCL) should be used.
Measurable disease per Modified Severity Weighted Assessment Tool (mSWAT) and/or Sezary count
Baseline skin biopsy taken within 6 months available for central review submission
Without bone marrow involvement: Absolute neutrophil count (ANC) >= 1,500/mm\^3 (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)
NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
With bone marrow involvement: ANC >= 1,000/mm\^3 (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)
NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
Without bone marrow involvement: Platelets >= 100,000/mm\^3 (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)
NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
With bone marrow involvement: Platelets >= 75,000/mm3 (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)
NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)(performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)
Aspartate aminotransferase (AST) =< 2.5 x ULN (unless has Gilbert's disease)(performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)
Alanine aminotransferase (ALT) =< 2.5 x ULN (unless has Gilbert's disease)(performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)
Creatinine clearance of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (unless has Gilbert's disease) (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)

You may not qualify if…

Prior mogamulizumab
Any systemic therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating protocol therapy
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy
Any skin-directed therapy within 14 days prior to initiating protocol therapy
Any radiation therapy within 21 days prior to initiating protocol therapy
Immunosuppressive medication within 14 days prior to the first dose of study treatment. The following are exceptions to this criterion:
Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection) and are on stable dose for at least 28 days
Systemic corticosteroids at physiologic doses of < 10 mg/day of prednisone or equivalent
Live, attenuated vaccine within 30 days prior to the first dose protocol therapy
Disease free of prior malignancies for >= 5 years with the exception of:
Currently treated squamous cell and basal cell carcinoma of the skin, or
Carcinoma in situ of the cervix, or
Surgically removed melanoma in situ of the skin (stage 0) with histological confirmed free margins of excision, or
Prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) that has/have been surgically cured, or
Any other malignancy that has/have been curatively treated with surgery and/or localized radiation
Active infection requiring antibiotics
Known hepatitis B or hepatitis C infection
Other active malignancy
Females only: Pregnant or breastfeeding
Prior stem cell transplantation
Acute infection requiring systemic treatment
Conditions requiring chronic steroid or immunosuppressive treatment that likely need additional steroid or immunosuppressive treatments in addition to the protocol therapy
Renal failure requiring hemodialysis or peritoneal dialysis
Unstable cardiac disease as defined by one of the following:
Cardiac events such as myocardial infarction (MI) within the past 6 months

Where it is running

Mayo Clinic — Scottsdale, Arizona, United States (enrolling)
City of Hope Medical Center — Duarte, California, United States (enrolling)
Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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