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Trial record 3 of 18 for:    kw-0761

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

This study has been completed.
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. ) Identifier:
First received: October 19, 2010
Last updated: June 14, 2016
Last verified: August 2013
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.

Condition Intervention Phase
Peripheral T-cell Lymphoma
Cutaneous T-cell Lymphoma
Biological: KW-0761
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Kyowa Kirin Pharmaceutical Development, Inc.:

Primary Outcome Measures:
  • To determine a Global Composite Response (skin, blood, lymph nodes)as determined by skin evaluations, blood counts and PET/CT imaging [ Time Frame: one year ]

Secondary Outcome Measures:
  • To determine the number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: one year ]

Enrollment: 1
Study Start Date: August 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KW-0761 Biological: KW-0761
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01226472

United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
Study Director: Michael Kurman, M.D. Kyowa Hakko Kirin Pharma, Inc.
  More Information

Responsible Party: Kyowa Hakko Kirin Pharma, Inc. Identifier: NCT01226472     History of Changes
Other Study ID Numbers: KW-0761-002
Study First Received: October 19, 2010
Last Updated: June 14, 2016

Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc.:

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin processed this record on May 25, 2017