PURPOSE:
Primary Objectives - To determine the efficacy of additional treatment in subjects who relapse after a complete response to KW 0761 treatment; to describe the adverse event profile in subjects receiving additional courses of KW-0761. Secondary Objective - To describe the immunogenicity of KW-0761.

ELIGIBILITY:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Conditions: Lymphomas: Non-Hodgkin; Lymphomas: Non-Hodgkin-Cutaneous Lymphoma
Health of Volunteers: People with the conditions listed in this trial can participate as controls.

INCLUSION CRITERIA:
* The subject is >= 18 years of age.
* 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.
* 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.
* The subject has serum creatinine <= 1.5 x ULN or a calculated creatinine clearance >60 mL/min.
* Subjects with MF and a history of staphylococcus colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics.
* The subject or his/her legal representative has provided signed informed consent. Written informed consent must be obtained prior to performing any study-related procedure.
* Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of receiving study medication.
* WOCBP must agree to use effective contraception, defined as oral contraceptives, double barrier method (condom plus spermicide or diaphragm) or abstain from sexual intercourse. WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea >= 12 consecutive months).
* Male subjects must be willing to use an appropriate method of contraception (e.g., condoms) or abstain from sexual intercourse and inform any sexual partners that they must also use a reliable method of contraception (e.g., birth control pills) during the study.

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);39 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.
* The subject has known or tests positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B or hepatitis C.
* The subject has evidence of central nervous system (CNS) metastasis.
* The subject is pregnant (confirmed by beta human chorionic gonadotrophin [beta-HCG]) or lactating.
* Subjects on any immunomodulatory drug, (other than low dose corticosteroids equivalent to a daily dose of 10 mg of prednisone), including but not limited to the following, will be excluded: pharmacologic doses of systemic steroids except as used to treat or prevent an infusion or allergic reaction to KW-0761 (topical steroids, inhalation steroids and replacement doses of systemic steroids are permitted); methotrexate; azathioprine; intravenous immunoglobulin; cyclophosphamide; cyclosporine; mycophenolate; infliximab; etanercept; leflunomide; adalimumab; abatacept; rituximab; anakinra; interferon-alpha; interferon-β; IL-2 and natalizumab. Subjects on any of the foregoing agents within 4 weeks of their first dose of KW-0761 are also excluded.
* 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.
* The subject has experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.
* Subjects with active herpes simplex or herpes zoster. Subjects with a history of herpes zoster who have had an outbreak within the last year will also be excluded. Subjects on prophylaxis for herpes who started taking medication at least 30 days prior to study entry, should continue to take the prescribed medication for the duration of the study.
* Subjects with known autoimmune diseases, including, but not limited to the following, will be excluded: multiple sclerosis; Grave’s disease; vasculitis; systemic lupus erythematosis; rheumatoid arthritis; systemic sclerosis; myasthenia gravis; ankylosing spondylitis; Wegener’s granulomatosis; ulcerative colitis; Crohn’s disease; psoriasis requiring systemic therapy; pemphigus; temporal arteritis; uveitis; dermatomyositis; Sjogren’s syndrome; Goodpasture’s syndrome; interstitial pneumonitis; interstitial nephritis; and Henoch-Schoenlein purpura. Subjects with a history of any of these disorders will also be excluded. Subjects with Hashimoto’s thyroiditis controlled with medication are eligible for enrollment.

SPONSOR:
Kyowa Hakko Kirin Pharma, Inc.
 

CLINICALTRIALS.GOV IDENTIFIER: NCT01226472

Contact:
Stanford University School of Medicine
300 Pasteur Drive, Stanford, CA 94305
Cutaneous Lymphoma Coordinator, 650.421.6370
Principal Investigator: Youn H. Kim, M.D.