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

Study Overview
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Brief Summary
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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.

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

Conditions
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Peripheral T/NK-cell Lymphoma

Intervention / Treatment
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* Biological: KW-0761


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KW-0761<br> | Biological: KW-0761<br>* Intravenously 8 times at 1-week intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor effect (best overall response) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor effect (best response by disease lesion), progression-free survival and overall survival |  |  | 
| Adverse events and anti-KW-0761 antibody levels |  |  | 
| Plasma KW-0761 concentrations and pharmacokinetic parameters |  |  |