Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001
Condition: Peripheral T-cell Lymphoma; Cutaneous T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Intervention: KW-0761
Intervention description: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
Intervention MeSH terms: Mogamulizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PTCL; CTCL; MF; SS

Summary:

      This study will enroll subjects with either Peripheral T-Cell Lymphoma (PTCL) or Cutaneous
      T-Cell Lymphoma(CTCL),including mycosis fungoides (MF) and Sezary Syndrome (SS), who have
      relapsed after achieving a complete response in study, KW-0761-001.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. The subject has relapsed after achieving a complete response to treatment with KW
             0761 for PTCL or CTCL on study, KW-0761-001.

             2. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status
             score of < 2 at study entry.

             3. The subject is >18 years of age. 4. The subject has adequate hematological
             function: absolute neutrophil count [ANC] >1,500 cells/uL and platelets >100,000
             cells/uL,except in patients with known bone marrow involvement where absolute
             neutrophil count [ANC] must be > 1,000 cells/uL and platelets >75,000 cells/uL.

             5. The subject has adequate hepatic function: bilirubin ≤ 1.5 times the specific
             institutional upper limit of normal [ULN]; aspartate transaminase [AST] and alanine
             transaminase [ALT] each ≤ 2.5 x ULN or ≤ 5.0 x ULN in the presence of known hepatic
             malignancy.

             6. The subject has serum creatinine ≤1.5 x ULN or a calculated creatinine clearance
             >60 mL/min.

             7. Subjects with MF and a history of staphylococcus colonization are eligible provided
             they continue to receive stable doses of prophylactic antibiotics.

        Exclusion Criteria:

          1. The subject has received any type of treatment for their disease since completing
             study, KW-0761-001.

          2. The subject has a significant uncontrolled intercurrent illness including, but not
             limited to: uncontrolled infection requiring antibiotics; clinically significant
             cardiac disease (class III or IV of the New York Heart Association [NYHA]
             classification); unstable angina pectoris; angioplasty, stenting, or myocardial
             infarction within 6 months; uncontrolled hypertension (systolic blood pressure >160
             mmHg, diastolic BP >100 mmHg, found on two consecutive measurements separated by a 1
             week period) despite two anti-hypertensive medications; clinically significant cardiac
             arrhythmia; or uncontrolled diabetes.

          3. Subjects on any immunomodulatory drug, (other than low dose corticosteroids equivalent
             to a daily dose of 10 mg of prednisone

          4. The subject has a psychiatric illness, disability or social situation that would
             compromise the subject's safety or ability to provide consent, or limit his or her
             compliance with study requirements.

          5. The subject has experienced allergic reactions to monoclonal antibodies or other
             therapeutic proteins.

          6. Subjects with active herpes simplex or herpes zoster.

          7. Subjects with known autoimmune diseases