Multicenter, randomized, open-label, parallel-group study to compare mLSG15 + KW-0761 to mLSG15

Phase 2

• Conditions: CCR4-positive adult T-cell leukemia-lymphoma (untreated primary disease)

• Registration Number: JPRN-jRCT2080221172
• Lead Sponsor: Kyowa Hakko Kirin Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified