CCR4-positive adult T-cell leukemia-lymphoma (untreated primary disease)
Conditions
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Complete response rate in the best overall response assessment for antitumor effect | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 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 Safety: Adverse events and anti-KW-0761 antibody Pharmacokinetics: Plasma KW-0761 concentrations and pharmacokinetic parameters | — |
Outcome results
None listed