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

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ClinicalTrials.gov Identifier: NCT01173887
Recruitment Status : Completed
First Posted : August 2, 2010
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adult T-cell Leukemia-Lymphoma Drug: VCAP/AMP/VECP(mLSG15) Biological: KW-0761 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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)
Study Start Date : July 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma

Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. Adverse events [ Time Frame: During the study period ]
  4. 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. ]
  5. 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. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173887


Locations
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Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT01173887    
Other Study ID Numbers: 0761-003
First Posted: August 2, 2010    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Leukemia, Lymphoid
Mogamulizumab
Antineoplastic Agents