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

This study has been completed.
Sponsor:
Information provided by:
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01173887
First received: July 30, 2010
Last updated: March 26, 2013
Last verified: March 2013

July 30, 2010
March 26, 2013
July 2010
April 2012   (final data collection date for primary outcome measure)
Complete response rate in the best overall response assessment for antitumor effect [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01173887 on ClinicalTrials.gov Archive Site
  • 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 [ Designated as safety issue: No ]
  • Adverse events and anti-KW-0761 antibody [ Designated as safety issue: Yes ]
  • Plasma KW-0761 concentrations and pharmacokinetic parameters [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Adult T-cell Leukemia-Lymphoma
  • Drug: VCAP/AMP/VECP(mLSG15)
    VCAP(Vincristine Sulfate, Cyclophosphamide Hydrate, Doxorubicin Hydrochloride, Prednisolone); AMP(Doxorubicin Hydrochloride, Ranimustine, Prednisolone); VECP(Vindesine Sulfate, Etoposide, Carboplatin, Prednisolone)
  • Biological: KW-0761
    VCAP/AMP/VECP(mLSG15) + KW-0761
  • Active Comparator: mLSG15
    Intervention: Drug: VCAP/AMP/VECP(mLSG15)
  • Experimental: mLSG15 + KW-0761
    Intervention: Biological: KW-0761
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
April 2012
April 2012   (final data collection date for primary outcome measure)

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
  • 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

Exclusion Criteria:

  • 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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01173887
0761-003
Not Provided
Clinical Science Department, Kyowa Hakko Kirin Company, Limited
Kyowa Hakko Kirin Company, Limited
Not Provided
Not Provided
Kyowa Hakko Kirin Company, Limited
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP