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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
VCAP(Vincristine Sulfate, Cyclophosphamide Hydrate, Doxorubicin Hydrochloride, Prednisolone); AMP(Doxorubicin Hydrochloride, Ranimustine, Prednisolone); VECP(Vindesine Sulfate, Etoposide, Carboplatin, Prednisolone)
VCAP/AMP/VECP(mLSG15) + KW-0761
Fukuoka University Hospital
Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Japan
National Kyushu Cancer Center
Fukuoka, Japan
Imamura Bun-in Hospital
Kagoshima, Japan
Kagoshima University Hospital
Kagoshima, Japan
Kokura Memorial Hospital
Kitakyushu, Japan
Kumamoto University Hospital
Kumamoto, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, Japan
NTT West Japan Kyushu Hospital
Kumamoto, Japan
Nagasaki University Hospital
Nagasaki, Japan
...and 9 more locations
Complete response rate in the best overall response assessment for antitumor effect
Time frame: After cycle 2 and cycle 4
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
Time frame: After cycle 2 and cycle 4.
Progression-free survival and Overall survival
Time frame: 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
Time frame: During the study period
anti-KW-0761 antibody
Time frame: 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
Time frame: 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.
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