Status:
COMPLETED
Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Peripheral T/NK-cell Lymphoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01192984
Start Date
September 1 2010
End Date
May 1 2012
Last Update
March 3 2017
Active Locations (15)
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1
Kyushu University Hospital
Fukuoka, Japan
2
National Kyushu Cancer Center
Fukuoka, Japan
3
Tokai University Hospital
Isehara, Japan
4
Imamura Bun-in Hospital
Kagoshima, Japan