Phase II study of KW-0761
- Conditions
- Adult T-cell leukemia-lymphoma
- Registration Number
- JPRN-jRCT2080220744
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 25
1: Positive for serum anti-HTLV-I antibody
2: Acute-, lymphoma-, or chronic-type with poor prognostic factors specified in the past
3: Positive for CCR4
4: Relapsed subject after the response (CR, CRu or PR) in the last previous chemotherapy
5: Received at least one prior chemotherapy
6: Only after 4 weeks had elapsed since the most recent treatment 4 weeks
7: PS of 0 to 2
8: Negative for HBs antigen and for HBV-DNA by a real-time PCR
1: A history of transplantation such as hematopoietic stem cells
2: Positive for HCV antibody or HIV antibody
3: Active multiple cancers at the time of starting this clinical study
4: Previous history of allergic reactions after receiving antibody products
5: Requiring continuous systemic treatment with a steroid
6: Requiring such radiotherapy after starting this clinical study
7: Treated with any investigational drug other than KW-0761 within three months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method