Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
Primary Purpose
Peripheral T/NK-cell Lymphoma
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KW-0761
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral T/NK-cell Lymphoma
Eligibility 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
Sites / Locations
- Kyushu University Hospital
- National Kyushu Cancer Center
- Tokai University Hospital
- Imamura Bun-in Hospital
- University Hospital, Kyoto Prefectural University of Medicine
- Nagasaki University Hospital
- Aichi Cancer Center Hospital
- Nagoya City University Hospital
- Nagoya Daini Red Cross Hospital,
- Okayama University Hospital
- Hokkaido University Hospital
- Tohoku University Hospital
- Cancer Institute Hospital
- National Cancer Center Hospital
- Mie University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KW-0761
Arm Description
Outcomes
Primary Outcome Measures
Antitumor effect (best overall response)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01192984
First Posted
August 30, 2010
Last Updated
February 28, 2017
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01192984
Brief Title
Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
Official Title
Phase II Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T/NK-cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KW-0761
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
KW-0761
Intervention Description
Intravenously 8 times at 1-week intervals
Primary Outcome Measure Information:
Title
Antitumor effect (best overall response)
Secondary Outcome Measure Information:
Title
Antitumor effect (best response by disease lesion), progression-free survival and overall survival
Title
Adverse events and anti-KW-0761 antibody levels
Title
Plasma KW-0761 concentrations and pharmacokinetic parameters
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kyushu University Hospital
City
Fukuoka
Country
Japan
Facility Name
National Kyushu Cancer Center
City
Fukuoka
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
Country
Japan
Facility Name
Imamura Bun-in Hospital
City
Kagoshima
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural University of Medicine
City
Kyoto
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki
Country
Japan
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya
Country
Japan
Facility Name
Nagoya Daini Red Cross Hospital,
City
Nagoya
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
Country
Japan
Facility Name
Cancer Institute Hospital
City
Tokyo
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
Country
Japan
Facility Name
Mie University Hospital
City
Tsu
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24616310
Citation
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.
Results Reference
derived
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Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
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