RECRUITING

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

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Conditions

Folliculotropic Mycosis FungoidesPrimary Cutaneous T-Cell Non-Hodgkin LymphomaSezary SyndromeStage IB Mycosis Fungoides and Sezary Syndrome AJCC v8Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8Transformed Mycosis Fungoides

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2022-10-19
Study Completion:2025-05-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04930653

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented informed consent of the participant and/or legally authorized representative
  2. * Assent, when appropriate, will be obtained per institutional guideline
  3. * Agreement to allow the use of archival tissue from diagnostic tumor biopsies
  4. * If unavailable, exceptions may be granted with study principal investigator (PI) approval
  5. * Age: \>= 18 years
  6. * Eastern Cooperative Oncology Group (ECOG) =\< 2
  7. * 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
  8. * Stage of disease according to Tumor-Node-Metastasis-Blood (TNMB) classification
  9. * Pathology report must be diagnostic or be consistent with MF/SS criteria
  10. * 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
  11. * 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.
  12. * Measurable disease per Modified Severity Weighted Assessment Tool (mSWAT) and/or Sezary count
  13. * Baseline skin biopsy taken within 6 months available for central review submission
  14. * 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)
  15. * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
  16. * With bone marrow involvement: ANC \>= 1,000/mm\^3 (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)
  17. * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
  18. * Without bone marrow involvement: Platelets \>= 100,000/mm\^3 (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)
  19. * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
  20. * With bone marrow involvement: Platelets \>= 75,000/mm3 (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)
  21. * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
  22. * 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)
  23. * 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)
  24. * 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)
  25. * 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)
  26. * 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)
  27. * 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)
  28. * 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)
  29. * 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)
  30. * Hepatitis C virus (HCV)\*, active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \[RPR\])
  31. * If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed
  32. * Meets other institutional and federal requirements for infectious disease titer requirements
  33. * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
  34. * Subjects with MF and a history of staphylococcus colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics
  35. * 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
  36. * 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
  37. * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
  1. * Prior mogamulizumab
  2. * Any systemic therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating protocol therapy
  3. * Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy
  4. * Any skin-directed therapy within 14 days prior to initiating protocol therapy
  5. * Any radiation therapy within 21 days prior to initiating protocol therapy
  6. * Immunosuppressive medication within 14 days prior to the first dose of study treatment. The following are exceptions to this criterion:
  7. * Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection) and are on stable dose for at least 28 days
  8. * Systemic corticosteroids at physiologic doses of \< 10 mg/day of prednisone or equivalent
  9. * Live, attenuated vaccine within 30 days prior to the first dose protocol therapy
  10. * Disease free of prior malignancies for \>= 5 years with the exception of:
  11. * Currently treated squamous cell and basal cell carcinoma of the skin, or
  12. * Carcinoma in situ of the cervix, or
  13. * Surgically removed melanoma in situ of the skin (stage 0) with histological confirmed free margins of excision, or
  14. * Prostate cancer (T1a or T1b using the TNM \[tumor, nodes, metastasis\] clinical staging system) that has/have been surgically cured, or
  15. * Any other malignancy that has/have been curatively treated with surgery and/or localized radiation
  16. * Active infection requiring antibiotics
  17. * Known hepatitis B or hepatitis C infection
  18. * Other active malignancy
  19. * Females only: Pregnant or breastfeeding
  20. * Prior stem cell transplantation
  21. * Acute infection requiring systemic treatment
  22. * Conditions requiring chronic steroid or immunosuppressive treatment that likely need additional steroid or immunosuppressive treatments in addition to the protocol therapy
  23. * Renal failure requiring hemodialysis or peritoneal dialysis
  24. * Unstable cardiac disease as defined by one of the following:
  25. * Cardiac events such as myocardial infarction (MI) within the past 6 months
  26. * NYHA (New York Heart Association) heart failure class III-IV
  27. * Uncontrolled atrial fibrillation or hypertension
  28. * Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment
  29. * 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:
  30. * Vitiligo or alopecia
  31. * Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or
  32. * Psoriasis not requiring systemic treatment
  33. * History of primary immunodeficiency
  34. * 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.
  35. * 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)

Contacts and Locations

Principal Investigator

Christiane R Querfeld
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Christiane R Querfeld, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-19
Study Completion Date2025-05-16

Study Record Updates

Study Start Date2022-10-19
Study Completion Date2025-05-16

Terms related to this study

Additional Relevant MeSH Terms

  • 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