Back to resultsPhase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma
Primary Purpose
Adult T-cell Leukemia-lymphoma
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KW-0761
Sponsored by
About this trial
This is an interventional treatment trial for Adult T-cell Leukemia-lymphoma
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KW-0761
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2)
Secondary Outcome Measures
Progression Free Survival (PFS)
The time from the date of first KW-0761 dosing to the date of progressive disease(PD) confirmation or death.
The antitumor response criteria including 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 Survival (OS)
The time from the date of first KW-0761 dosing to the date of death.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00920790
Brief Title
Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma
Official Title
Phase II Clinical Study of KW-0761 in Patients With CCR4-Positive Adult T-cell Leukemia-Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult T-cell Leukemia-lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KW-0761
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
KW-0761
Other Intervention Name(s)
Mogamulizumab
Intervention Description
KW-0761 is administered weekly for 8 weeks as an intravenous infusion of 2 hours at a dose of 1.0 mg/kg.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
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.
Title
Pharmacokinetics-Plasma KW-0761 Concentrations
Description
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.
Time Frame
0 to 7 days post final dose
Title
Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days)
Description
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.
Time Frame
0 to 7 days post final dose
Title
Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2)
Time Frame
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 Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
The time from the date of first KW-0761 dosing to the date of progressive disease(PD) confirmation or death.
The antitumor response criteria including 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).
Time Frame
Baseline to response
Title
Overall Survival (OS)
Description
The time from the date of first KW-0761 dosing to the date of death.
Time Frame
Baseline to response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22312108
Citation
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.
Results Reference
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Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma
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