Phase II study of KW-0761 in subjects with CCR4-positive peripheral T/NK-cell lymphoma

Phase 2

• Conditions: CCR4-positive peripheral T/NK-cell lymphoma

• Registration Number: JPRN-jRCT2080221219
• 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: 2010-08-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified