Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001

Not Recruiting

Trial ID: NCT01226472


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.

Official Title

Open-Label Extension Study of Anti-CCR4 Monoclonal Antibody KW-0761 as Monotherapy in Subjects Who Relapsed After Complete Response on Study KW-0761-001

Stanford Investigator(s)

Youn H Kim, MD
Youn H Kim, MD

The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology

Richard Hoppe
Richard Hoppe

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology


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

   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


biological: KW-0761

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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