Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
NCT ID: NCT01192984
Last Updated: 2017-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2010-09-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
Study Groups
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KW-0761
KW-0761
Intravenously 8 times at 1-week intervals
Interventions
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KW-0761
Intravenously 8 times at 1-week intervals
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Ogura M, Ishida T, Hatake K, Taniwaki M, Ando K, Tobinai K, Fujimoto K, Yamamoto K, Miyamoto T, Uike N, Tanimoto M, Tsukasaki K, Ishizawa K, Suzumiya J, Inagaki H, Tamura K, Akinaga S, Tomonaga M, Ueda R. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1157-63. doi: 10.1200/JCO.2013.52.0924. Epub 2014 Mar 10.
Other Identifiers
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0761-004
Identifier Type: -
Identifier Source: org_study_id
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