Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01192984
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd

Brief Summary:
The purpose of this study is to evaluate the efficacy of KW-0761 intravenously administered eight times at one-week intervals in patients with CCR4-positive peripheral T/NK-cell lymphoma. The primary objective is to assess the antitumor effect in terms of best overall response, while the secondary objectives are to assess the antitumor effect in terms of best response by disease lesion, to assess the progression-free survival and to assess the overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also evaluated.

Condition or disease Intervention/treatment Phase
Peripheral T/NK-cell Lymphoma Biological: KW-0761 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Phase II Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
Study Start Date : September 2010
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: KW-0761 Biological: KW-0761
Intravenously 8 times at 1-week intervals

Primary Outcome Measures :
  1. Antitumor effect (best overall response)

Secondary Outcome Measures :
  1. Antitumor effect (best response by disease lesion), progression-free survival and overall survival
  2. Adverse events and anti-KW-0761 antibody levels
  3. Plasma KW-0761 concentrations and pharmacokinetic parameters

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with hematologically or pathohistologically diagnosed peripheral T/NK-cell lymphoma
  • Subjects who have been positive for CCR4
  • Subjects who received one or more chemotherapy regimens
  • Subjects who relapse after achieving complete response, uncertain complete response or partial response by the last chemotherapy
  • Subjects who have an interval of 4 weeks or more between the last day of the prior therapy and the scheduled day of the first KW-0761 treatment
  • Subjects with nodal lesions, extranodal lesions and/or cutaneous lesions
  • Subjects who have a performance status of 0 to 2
  • Subjects who are negative for HBs antigen and reported as "not detected" for HBV-DNA
  • Subjects who are negative for anti-HCV antibody
  • Subjects who have normal function of the major organs
  • Subjects who have given written voluntary informed consent to participate in the study

Exclusion Criteria:

  • Subjects who underwent transplant therapy such as hematopoietic stem-cell transplantation (Subjects who underwent autologous hematopoietic stem-cell transplantation following chemotherapy will not be excluded)
  • Subjects who are known carriers of HIV
  • Subjects who have active multiple cancer
  • Subjects who have a history of allergic reactions to therapeutic antibodies
  • Subjects requiring continuous systemic treatment with steroid
  • Subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses at enrollment or who may require such radiotherapy after the start of the study
  • Subjects who are pregnant, lactating or of childbearing potential, or who are planning to have children

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01192984

Kyushu University Hospital
Fukuoka, Japan
National Kyushu Cancer Center
Fukuoka, Japan
Tokai University Hospital
Isehara, Japan
Imamura Bun-in Hospital
Kagoshima, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Japan
Nagasaki University Hospital
Nagasaki, Japan
Aichi Cancer Center Hospital
Nagoya, Japan
Nagoya City University Hospital
Nagoya, Japan
Nagoya Daini Red Cross Hospital,
Nagoya, Japan
Okayama University Hospital
Okayama, Japan
Hokkaido University Hospital
Sapporo, Japan
Tohoku University Hospital
Sendai, Japan
Cancer Institute Hospital
Tokyo, Japan
National Cancer Center Hospital
Tokyo, Japan
Mie University Hospital
Tsu, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kyowa Hakko Kirin Co., Ltd Identifier: NCT01192984     History of Changes
Other Study ID Numbers: 0761-004
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Lymphoma, Extranodal NK-T-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin