Clinical Trial: Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Pr

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 Summary:
Sponsor: Kyowa Hakko Kirin Co., Ltd

Current Primary Outcome: Complete response rate in the best overall response assessment for antitumor effect [ Time Frame: After cycle 2 and cycle 4 ]

Original Primary Outcome: Complete response rate in the best overall response assessment for antitumor effect

Current Secondary Outcome:

  • 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. ]


Original Secondary Outcome:

  • 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, progression-free survival and overall survival
  • Adverse events and anti-KW-0761 antibody
  • Plasma KW-0761 concentrations and pharmacokinetic parameters


Information By: Kyowa Hakko Kirin Co., Ltd

Dates:
Date Received: July 30, 2010
Date Started: July 2010
Date Completion:
Last Updated: March 29, 2017
Last Verified: March 2017