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NCT Number: NCT01173887

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

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.

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Key information

Conditions

Adult T-Cell Leukemia-Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fukuoka University Hospital, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VCAP/AMP/VECP(mLSG15)

Drug

VCAP(Vincristine Sulfate, Cyclophosphamide Hydrate, Doxorubicin Hydrochloride, Prednisolone); AMP(Doxorubicin Hydrochloride, Ranimustine, Prednisolone); VECP(Vindesine Sulfate, Etoposide, Carboplatin, Prednisolone)

KW-0761

Biological

VCAP/AMP/VECP(mLSG15) + KW-0761

Primary outcomes

  1. Complete response rate in the best overall response assessment for antitumor effect

    Time frame: After cycle 2 and cycle 4

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 2, 2010
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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