Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: mLSG15
|
Drug: VCAP/AMP/VECP(mLSG15)
VCAP(Vincristine Sulfate, Cyclophosphamide Hydrate, Doxorubicin Hydrochloride, Prednisolone); AMP(Doxorubicin Hydrochloride, Ranimustine, Prednisolone); VECP(Vindesine Sulfate, Etoposide, Carboplatin, Prednisolone)
|
| Experimental: mLSG15 + KW-0761
|
Biological: KW-0761
VCAP/AMP/VECP(mLSG15) + KW-0761
|
Outcome Measures
Primary Outcome Measures
- Complete response rate in the best overall response assessment for antitumor effect [After cycle 2 and cycle 4]
Secondary Outcome Measures
- 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.]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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Subjects who have been classified into acute subtype, the lymphoma subtype or chronic subtype with poor prognostic factors
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Subjects who have been positive for CCR4 by CCR4 expression analysis
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Subjects who have never been treated for adult T-cell leukemia-lymphoma
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Subjects who have presented enlarged lymph nodes, tumor nodules in extranodal organs, abnormal lymphocytes in peripheral blood or cutaneous lesions
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Subjects with a performance status of 0 to 2
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Subjects who have been negative for HBs antigen and anti-HCV antibody
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Subjects who have given written voluntary informed consent to participate in the study
Exclusion Criteria:
-
Subjects who are scheduled for transplant therapy such as hematopoietic stem-cell transplantation
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Subjects who had myocardial infarction within 12 months before study enrollment or who have cardiac disease that may worsen during treatment with doxorubicin
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Subjects who have been positive for anti-HIV antibody
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Subjects with active multiple cancer
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Subjects with a history of allergic reactions to therapeutic antibodies
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fukuoka University Hospital | Fukuoka | Japan | ||
| 2 | Kyushu University Hospital | Fukuoka | Japan | ||
| 3 | National Kyushu Cancer Center | Fukuoka | Japan | ||
| 4 | Imamura Bun-in Hospital | Kagoshima | Japan | ||
| 5 | Kagoshima University Hospital | Kagoshima | Japan | ||
| 6 | Kokura Memorial Hospital | Kitakyushu | Japan | ||
| 7 | Kumamoto University Hospital | Kumamoto | Japan | ||
| 8 | National Hospital Organization Kumamoto Medical Center | Kumamoto | Japan | ||
| 9 | NTT West Japan Kyushu Hospital | Kumamoto | Japan | ||
| 10 | Nagasaki University Hospital | Nagasaki | Japan | ||
| 11 | The Japanese Red Cross Nagasaki Genbaku Hospital | Nagasaki | Japan | ||
| 12 | Aichi Cancer Center Hospital | Nagoya | Japan | ||
| 13 | Nagoya City University Hospital | Nagoya | Japan | ||
| 14 | Oita Prefectural Hospital | Oita | Japan | ||
| 15 | Heartlife Hospital | Okinawa | Japan | ||
| 16 | National Hospital Organization Nagasaki Medical Center | Omura | Japan | ||
| 17 | Sasebo City General Hospital | Sasebo | Japan | ||
| 18 | National Cancer Center Hospital | Tokyo | Japan | ||
| 19 | Ehime University Hospital | Toon | Japan |
Sponsors and Collaborators
- Kyowa Kirin Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0761-003