CCR4-positive peripheral T/NK-cell lymphoma
Conditions
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects with hematologically or pathohistologically diagnosed peripheral T/NK-cell lymphoma - Subjects who are positive for CCR4 - Subjects who received one or more chemotherapy regimens - Subjects who relapse after achieving complete response, uncertain complete response or partial response by the last chemotherapy - Subjects who have an interval of 4 weeks or more between the last day of the prior therapy and the scheduled day of the first KW-0761 treatment - Subjects with nodal lesions, extranodal lesions and/or cutaneous lesions - Subjects who have a performance status of 0 to 2 - Subjects who are negative for HBs antigen and reported as "not detected" for HBV-DNA - Subjects who are negative for anti-HCV antibody - Subjects who have normal function of the major organs - Subjects who have given written voluntary informed consent to participate in the study
Exclusion criteria
Exclusion criteria: - Subjects who underwent transplant therapy such as hematopoietic stem-cell transplantation (Subjects who underwent autologous hematopoietic stem-cell transplantation following chemotherapy will not be excluded) - Subjects who are known carriers of HIV - Subjects who have active multiple cancer - Subjects who have a history of allergic reactions to therapeutic antibodies - Subjects requiring continuous systemic treatment with steroid - Subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses at enrollment 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: Antitumor effect (best overall response) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Antitumor effect (best response by disease lesion), progression-free survival and overall survival Safety: Adverse events and anti-KW-0761 antibody levels Pharmacokinetics: Plasma KW-0761 concentrations and pharmacokinetic parameters | — |
Outcome results
None listed