Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Kyowa Hakko Kirin Company, Limited Kyowa Kirin Co., Ltd.