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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01192984
First received: August 30, 2010
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Peripheral T/NK-cell Lymphoma
Biological: KW-0761
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • Antitumor effect (best overall response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antitumor effect (best response by disease lesion), progression-free survival and overall survival [ Designated as safety issue: No ]
  • Adverse events and anti-KW-0761 antibody levels [ Designated as safety issue: Yes ]
  • Plasma KW-0761 concentrations and pharmacokinetic parameters [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: September 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KW-0761 Biological: KW-0761
Intravenously 8 times at 1-week intervals

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192984

Locations
Japan
National Kyushu Cancer Center
Fukuoka, Japan
Kyushu University Hospital
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
National Cancer Center Hospital
Tokyo, Japan
Cancer Institute Hospital
Tokyo, Japan
Mie University Hospital
Tsu, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided by Kyowa Hakko Kirin Company, Limited

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01192984     History of Changes
Other Study ID Numbers: 0761-004
Study First Received: August 30, 2010
Last Updated: September 11, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on October 29, 2014