Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15
- Conditions
- Adult T-cell Leukemia-Lymphoma
- Interventions
- Drug: VCAP/AMP/VECP(mLSG15)Biological: KW-0761
- Registration Number
- NCT01173887
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
This is a multicenter, randomized, open-label, parallel-group study to compare mLSG15 + KW-0761 to mLSG15 in subjects with CCR4-positive adult T-cell leukemia-lymphoma (untreated primary disease). The primary variable is an efficacy of KW-0761 used as an add-on therapy to mLSG15 as measured in terms of complete response rate (CR/CRu) in the best overall response assessment for antitumor effect. The secondary variables include response rate (CR/CRu/PR) in the best overall response assessment for antitumor effect, complete or response rates by lesion site in the best overall response assessment for antitumor effect, progression-free survival and overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also determined.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- Subjects who have been positive for serum anti-human T-cell lymphotropic virus type I antibody
- Subjects with hematologically or pathohistologically confirmed as peripheral lymphoid tumor which surface antigen analysis has identified to be of T-cell origin
- Subjects who have been classified into acute subtype, the lymphoma subtype or chronic subtype with poor prognostic factors
- Subjects who have been positive for CCR4 by CCR4 expression analysis
- Subjects who have never been treated for adult T-cell leukemia-lymphoma
- Subjects who have presented enlarged lymph nodes, tumor nodules in extranodal organs, abnormal lymphocytes in peripheral blood or cutaneous lesions
- Subjects with a performance status of 0 to 2
- Subjects who have been negative for HBs antigen and anti-HCV antibody
- Subjects who have given written voluntary informed consent to participate in the study
- Subjects who are scheduled for transplant therapy such as hematopoietic stem-cell transplantation
- Subjects who had myocardial infarction within 12 months before study enrollment or who have cardiac disease that may worsen during treatment with doxorubicin
- Subjects who have been positive for anti-HIV antibody
- Subjects with active multiple cancer
- Subjects with a history of allergic reactions to therapeutic antibodies
- Subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mLSG15 VCAP/AMP/VECP(mLSG15) - mLSG15 + KW-0761 KW-0761 -
- Primary Outcome Measures
Name Time Method Complete response rate in the best overall response assessment for antitumor effect After cycle 2 and cycle 4
- Secondary Outcome Measures
Name Time Method Response rate in the best overall response assessment for antitumor effect, complete or response rates by lesion site in the best overall response assessment for antitumor effect After cycle 2 and cycle 4. Progression-free survival and Overall survival During the study period at least once every two months in the first year and once every three months in the second and subsequent years. Adverse events During the study period anti-KW-0761 antibody Before 1st and 5th dosing, 14 days after 8th or last dosing and at the start of post-treatment. Plasma KW-0761 concentrations and pharmacokinetic parameters Before and after 1st, 2nd, 3rd, 4th, 5th, 6th, 7th and 8th dosing, 14 days after 8th or last dosing, and at the start of post-treatment.
Trial Locations
- Locations (19)
Imamura Bun-in Hospital
🇯🇵Kagoshima, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
Kokura Memorial Hospital
🇯🇵Kitakyushu, Japan
National Hospital Organization Kumamoto Medical Center
🇯🇵Kumamoto, Japan
Nagasaki University Hospital
🇯🇵Nagasaki, Japan
Aichi Cancer Center Hospital
🇯🇵Nagoya, Japan
Fukuoka University Hospital
🇯🇵Fukuoka, Japan
National Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
NTT West Japan Kyushu Hospital
🇯🇵Kumamoto, Japan
The Japanese Red Cross Nagasaki Genbaku Hospital
🇯🇵Nagasaki, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Oita Prefectural Hospital
🇯🇵Oita, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Japan
Heartlife Hospital
🇯🇵Okinawa, Japan
National Hospital Organization Nagasaki Medical Center
🇯🇵Omura, Japan
Sasebo City General Hospital
🇯🇵Sasebo, Japan
Ehime University Hospital
🇯🇵Toon, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Japan