- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01192984
Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
February 28, 2017 updated by: Kyowa Kirin Co., Ltd.
Phase II Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Fukuoka, Japan
- Kyushu University Hospital
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Fukuoka, Japan
- National Kyushu Cancer Center
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Isehara, Japan
- Tokai University Hospital
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Kagoshima, Japan
- Imamura Bun-in Hospital
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Kyoto, Japan
- University Hospital, Kyoto Prefectural University of Medicine
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Nagasaki, Japan
- Nagasaki University Hospital
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Nagoya, Japan
- Aichi Cancer Center Hospital
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Nagoya, Japan
- Nagoya City University Hospital
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Nagoya, Japan
- Nagoya Daini Red Cross Hospital,
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Okayama, Japan
- Okayama University Hospital
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Sapporo, Japan
- Hokkaido University Hospital
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Sendai, Japan
- Tohoku University Hospital
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Tokyo, Japan
- National Cancer Center Hospital
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Tokyo, Japan
- Cancer Institute Hospital
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Tsu, Japan
- Mie University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: KW-0761
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Intravenously 8 times at 1-week intervals
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Antitumor effect (best overall response)
|
Secondary Outcome Measures
Outcome Measure |
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Antitumor effect (best response by disease lesion), progression-free survival and overall survival
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Adverse events and anti-KW-0761 antibody levels
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Plasma KW-0761 concentrations and pharmacokinetic parameters
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
August 30, 2010
First Submitted That Met QC Criteria
August 31, 2010
First Posted (Estimate)
September 1, 2010
Study Record Updates
Last Update Posted (Actual)
March 3, 2017
Last Update Submitted That Met QC Criteria
February 28, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0761-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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