Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Adult T-cell Leukemia-lymphoma |
Biological: KW-0761 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Clinical Study of KW-0761 in Patients With CCR4-Positive Adult T-cell Leukemia-Lymphoma |
- Overall Response Rate (ORR) [ 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. ] [ Designated as safety issue: No ]
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 [ Time Frame: 0 to 7 days post final dose ] [ Designated as safety issue: No ]
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) [ Time Frame: 0 to 7 days post final dose ] [ Designated as safety issue: No ]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) [ 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). ] [ Designated as safety issue: No ]
- Progression Free Survival (PFS) [ Time Frame: Baseline to response ] [ Designated as safety issue: No ]
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) [ Time Frame: Baseline to response ] [ Designated as safety issue: No ]The time from the date of first KW-0761 dosing to the date of death.
| Enrollment: | 28 |
| Study Start Date: | June 2009 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
-
Biological: KW-0761
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Publications:
| Responsible Party: | Kyowa Hakko Kirin Company, Limited |
| ClinicalTrials.gov Identifier: | NCT00920790 History of Changes |
| Other Study ID Numbers: | 0761-002 |
| Study First Received: | June 9, 2009 |
| Results First Received: | July 9, 2012 |
| Last Updated: | August 24, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Leukemia Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Lymphoma Neoplasms by Histologic Type Neoplasms |
Leukemia, Lymphoid Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013