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Back|NCT04930653Recruiting
Official Title

A Phase II Study of Combination Extracorporeal Photopheresis (ECP) and Mogamulizumab in Erythrodermic CTCL

Phase
Phase 2
Sponsor
City of Hope Medical Center
Enrollment
34
Timeline
Oct 2022 → Jun 2028
About This Study

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).

Eligibility Criteria

Inclusion Criteria

  • 1Documented informed consent of the participant and/or legally authorized representative
  • 2Assent, when appropriate, will be obtained per institutional guideline
  • 3Agreement to allow the use of archival tissue from diagnostic tumor biopsies
  • 4If unavailable, exceptions may be granted with study principal investigator (PI) approval
  • 5Age: \>= 18 years
  • 6Eastern Cooperative Oncology Group (ECOG) =\< 2
  • 7Histologically confirmed mycosis fungoides (MF) or Sezary syndrome (SS). Safety lead-in: \>= stage IIB OR \>= stage IB-IIA folliculotropic/transformed MF. Phase 2: \>= stage IB
  • 8Stage of disease according to Tumor-Node-Metastasis-Blood (TNMB) classification
  • 9Pathology report must be diagnostic or be consistent with MF/SS criteria
  • 10SS 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
  • 11For 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.
  • 12Measurable disease per Modified Severity Weighted Assessment Tool (mSWAT) and/or Sezary count
  • 13Baseline skin biopsy taken within 6 months available for central review submission
  • 14Without 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)
  • 15NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
  • 16With bone marrow involvement: ANC \>= 1,000/mm\^3 (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)
  • 17NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
  • 18Without bone marrow involvement: Platelets \>= 100,000/mm\^3 (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)
  • 19NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
  • 20With bone marrow involvement: Platelets \>= 75,000/mm3 (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)
  • 21NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
  • 22Total 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)
  • 23Aspartate 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)
  • 24Alanine 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)
  • 25Creatinine 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)
  • 26If 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)
  • 27If 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)
  • 28If 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)
  • 29If 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)
  • 30Hepatitis C virus (HCV)\*, active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \[RPR\])
  • 31If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed
  • 32Meets other institutional and federal requirements for infectious disease titer requirements
  • 33Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
  • 34Subjects with MF and a history of staphylococcus colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics
  • 35Women 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
  • 36Agreement 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
  • 37Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Exclusion Criteria

  • 1Prior mogamulizumab
  • 2Any systemic therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating protocol therapy
  • 3Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy
  • 4Any skin-directed therapy within 14 days prior to initiating protocol therapy
  • 5Any radiation therapy within 21 days prior to initiating protocol therapy
  • 6Immunosuppressive medication within 14 days prior to the first dose of study treatment. The following are exceptions to this criterion:
  • 7Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection) and are on stable dose for at least 28 days
  • 8Systemic corticosteroids at physiologic doses of \< 10 mg/day of prednisone or equivalent
  • 9Live, attenuated vaccine within 30 days prior to the first dose protocol therapy
  • 10Disease free of prior malignancies for \>= 5 years with the exception of:
  • 11Currently treated squamous cell and basal cell carcinoma of the skin, or
  • 12Carcinoma in situ of the cervix, or
  • 13Surgically removed melanoma in situ of the skin (stage 0) with histological confirmed free margins of excision, or
  • 14Prostate cancer (T1a or T1b using the TNM \[tumor, nodes, metastasis\] clinical staging system) that has/have been surgically cured, or
  • 15Any other malignancy that has/have been curatively treated with surgery and/or localized radiation
  • 16Active infection requiring antibiotics
  • 17Known hepatitis B or hepatitis C infection
  • 18Other active malignancy
  • 19Females only: Pregnant or breastfeeding
  • 20Prior stem cell transplantation
  • 21Acute infection requiring systemic treatment
  • 22Conditions requiring chronic steroid or immunosuppressive treatment that likely need additional steroid or immunosuppressive treatments in addition to the protocol therapy
  • 23Renal failure requiring hemodialysis or peritoneal dialysis
  • 24Unstable cardiac disease as defined by one of the following:
  • 25Cardiac events such as myocardial infarction (MI) within the past 6 months
  • 26NYHA (New York Heart Association) heart failure class III-IV
  • 27Uncontrolled atrial fibrillation or hypertension
  • 28Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment
  • 29Active 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:
  • 30Vitiligo or alopecia
  • 31Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or
  • 32Psoriasis not requiring systemic treatment
  • 33History of primary immunodeficiency
  • 34Any 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.
  • 35Prospective 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)

Locations

3 sites participating in this study

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

Recruiting

Pamela Allen, MD

pamela.b.allen@emory.edu404-778-6195

Mayo Clinic

Scottsdale, Arizona 85259

Recruiting

Aaron Mangold, MD

Mangold.Aaron@mayo.edu480-301-8484

City of Hope Medical Center

Duarte, California 91010

Recruiting

Christiane R. Querfeld

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →