Status:
COMPLETED
Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Adult T-cell Leukemia-lymphoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy, safety and pharmacokinetic profiles of KW-0761, the anti-CC chemokine receptor 4 (CCR4) antibody, when administered weekly for 8 weeks as an intravenous infusion at a dose of...
Eligibility Criteria
Inclusion
- Positive for serum anti-HTLV-I antibody
- Acute-, lymphoma-, or chronic-type with poor prognostic factors specified in the past
- Positive for CCR4
- Relapsed subject after the response (CR, CRu or PR) in the last previous chemotherapy
- Received at least one prior chemotherapy
- Subjects with an interval of four weeks or more between the last day of the previous treatment and the scheduled day of the first KW-0761 treatment
- PS of 0 to 2
- Negative for HBs antigen and for HBV-DNA by a real-time PCR
Exclusion
- A history of transplantation such as hematopoietic stem cells
- Positive for HCV antibody or HIV antibody
- Active multiple cancers at the time of starting this clinical study
- Previous history of allergic reactions after receiving antibody products
- Requiring continuous systemic treatment with a steroid
- Requiring such radiotherapy after starting this clinical study
- Treated with any investigational drug other than KW-0761 within three months
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00920790
Start Date
June 1 2009
End Date
November 1 2010
Last Update
March 29 2017
Active Locations (1)
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1
Tokyo, Japan