Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma
Phase II Clinical Study of KW-0761 in Patients With CCR4-Positive Adult T-cell Leukemia-Lymphoma
1 other identifier
interventional
28
1 country
1
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 1.0 mg/kg in relapsed subjects with CCR4-positive adult T-cell leukemia-lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 9, 2009
CompletedFirst Posted
Study publicly available on registry
June 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
September 25, 2012
CompletedMarch 29, 2017
February 1, 2017
1.1 years
June 9, 2009
July 9, 2012
February 28, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Overall Response Rate (ORR)
Response rate defined as the proportion of responders relative to the total population and its exact 95% confidence interval were calculated for best overall response. The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).Overall Response (OR)= CR + PR.
From date of first subject's consent to participate in the study until the date of last protocol-specified examination for last subject completed, assessed up to 14 months.
Pharmacokinetics-Plasma KW-0761 Concentrations
Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling. The baseline and maximum time point at which Cmax and Ctrough were collected are 0 to 7 days post-dose.
0 to 7 days post final dose
Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days)
Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling.
0 to 7 days post final dose
Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2)
0 to 28 days post final dose and follow-up examinations (1 month and 3 months after the end of the post-dosing observation period).
Secondary Outcomes (2)
Progression Free Survival (PFS)
Baseline to response
Overall Survival (OS)
Baseline to response
Study Arms (1)
KW-0761
EXPERIMENTALInterventions
KW-0761 is administered weekly for 8 weeks as an intravenous infusion of 2 hours at a dose of 1.0 mg/kg.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Tokyo, Japan
Related Publications (1)
Ishida T, Joh T, Uike N, Yamamoto K, Utsunomiya A, Yoshida S, Saburi Y, Miyamoto T, Takemoto S, Suzushima H, Tsukasaki K, Nosaka K, Fujiwara H, Ishitsuka K, Inagaki H, Ogura M, Akinaga S, Tomonaga M, Tobinai K, Ueda R. Defucosylated anti-CCR4 monoclonal antibody (KW-0761) for relapsed adult T-cell leukemia-lymphoma: a multicenter phase II study. J Clin Oncol. 2012 Mar 10;30(8):837-42. doi: 10.1200/JCO.2011.37.3472. Epub 2012 Feb 6.
PMID: 22312108RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Project Management Department, Development Division
- Organization
- Kyowa Hakko Kirin
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2009
First Posted
June 15, 2009
Study Start
June 1, 2009
Primary Completion
July 1, 2010
Study Completion
November 1, 2010
Last Updated
March 29, 2017
Results First Posted
September 25, 2012
Record last verified: 2017-02