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

Kyowa Kirin

Status and phase

Completed

Phase 2

Conditions

Adult T-cell Leukemia-Lymphoma

Treatments

Drug: VCAP/AMP/VECP(mLSG15)

Biological: KW-0761

Study type

Interventional

Funder types

Industry

Identifiers

NCT01173887

0761-003

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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