Treatment for erythrodermic cutaneous T cell lymphoma using photopheresis and mogamulizumab
Official title: A Phase II Study of Combination Extracorporeal Photopheresis (ECP) and Mogamulizumab in Erythrodermic CTCL
Run by City of Hope Medical Center · NCT04930653 · Data updated 2026-11-12
This study is testing a new treatment combining light therapy and a medication for people with a rare skin cancer called erythrodermic cutaneous T cell lymphoma to see if it helps them feel better and improves their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | mogamulizumab, Chemotherapy, immunotherapy, radiation, prednisone |
| Locations | 3 sites (Scottsdale, Arizona and 2 other locations) |
| Status | Recruiting |
| Started | October 19, 2022 |
| Main results expected | June 15, 2028 |
| Study ends | June 15, 2028 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT04930653 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with histologically confirmed mycosis fungoides or Sezary syndrome at stage IB or higher.
✕Probably not a fit
Patients with lower stage CTCL or those who have previously received mogamulizumab may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II trial evaluates the effectiveness of extracorporeal photopheresis (ECP) combined with mogamulizumab in patients with erythrodermic cutaneous T cell lymphoma (CTCL), a rare skin cancer. The study aims to assess the tolerability and overall response rate of this combination in patients who have not previously received mogamulizumab. Participants will receive mogamulizumab intravenously and undergo ECP treatment, with follow-up assessments to evaluate response rates, survival, and quality of life. The trial will also explore the immunomodulatory effects of both treatments on the cancer microenvironment.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from erythrodermic cutaneous T cell lymphoma.
How similar studies have gone: While this approach combines established treatments, the specific combination of ECP and mogamulizumab in this context is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) * If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) =\< 1.5 x ULN (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated) * If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated) * If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated) * If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated) * Hepatitis C virus (HCV)\*, active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \[RPR\]) * If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed * Meets other institutional and federal requirements for infectious disease titer requirements * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy * Subjects with MF and a history of staphylococcus colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Agreement by females and males of childbearing potential\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * 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 * NYHA (New York Heart Association) heart failure class III-IV * Uncontrolled atrial fibrillation or hypertension * Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment * Active or prior documented autoimmune or inflammatory disorders requiring therapy within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: * Vitiligo or alopecia * Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or * Psoriasis not requiring systemic treatment * History of primary immunodeficiency * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures. * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Where it's running
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City of Hope Medical Center
Duarte, California, United States Recruiting -
Mayo Clinic
Scottsdale, Arizona, United States Suspended -
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States Suspended
Study contacts
- Principal investigator: Christiane R Querfeld — City of Hope Medical Center
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.