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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier:
NCT01173887
First received: July 30, 2010
Last updated: March 29, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Adult T-cell Leukemia-Lymphoma Drug: VCAP/AMP/VECP(mLSG15) Biological: KW-0761 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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 Primary Disease)

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

Primary Outcome Measures:
  • Complete response rate in the best overall response assessment for antitumor effect [ Time Frame: 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 [ 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. ]

Enrollment: 44
Study Start Date: July 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173887

Locations
Japan
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
The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, Japan
Aichi Cancer Center Hospital
Nagoya, Japan
Nagoya City University Hospital
Nagoya, Japan
Oita Prefectural Hospital
Oita, Japan
Heartlife Hospital
Okinawa, Japan
National Hospital Organization Nagasaki Medical Center
Omura, Japan
Sasebo City General Hospital
Sasebo, Japan
National Cancer Center Hospital
Tokyo, Japan
Ehime University Hospital
Toon, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01173887     History of Changes
Other Study ID Numbers: 0761-003
Study First Received: July 30, 2010
Last Updated: March 29, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Leukemia-Lymphoma, Adult T-Cell
Leukemia
Leukemia, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid

ClinicalTrials.gov processed this record on August 16, 2017