| Eligibility |
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)
|
