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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)


Phase 2
20 Years
N/A
Not Enrolling
Both
Adult T-cell Leukemia-Lymphoma

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

0761-003

NCT ID:

NCT01173887

Start Date:

July 2010

Completion Date:

April 2012

Related Keywords:

  • Adult T-cell Leukemia-lymphoma
  • Leukemia
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma

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