A Phase 2 interventional study of KW-0761 in Adult T-cell Leukemia-lymphoma, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-03-29.
Sponsored by Kyowa Kirin Co., Ltd. · Phase 2, Interventional, and Treatment
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.
5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 28 is below the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.
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Biological: KW-0761
KW-0761 is administered weekly for 8 weeks as an intravenous infusion of 2 hours at a dose of 1.0 mg/kg.
Also known as: Mogamulizumab
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.
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.
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.
Time frame: 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.
Time frame: 0 to 7 days post final dose
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).
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).
Time frame: Baseline to response
Overall Survival (OS)
The time from the date of first KW-0761 dosing to the date of death.
Time frame: Baseline to response
Participants were enrolled from 1 June 2009 through 9 November 2010
| Milestone | KW-0761 |
|---|---|
| Started | 27 |
| Completed | 13 |
| Not completed | 14 |
| Withdrew: Aggravation of general condition | 14 |
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.
| percentage of participants with response | KW-0761 |
|---|---|
| Overall Response Rate (ORR) | 50 (29.9 to 70.1) |
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).
| days | KW-0761 |
|---|---|
| Progression Free Survival (PFS) | 97 (12 to 401) |
The time from the date of first KW-0761 dosing to the date of death.
| days | KW-0761 |
|---|---|
| Overall Survival (OS) | 176.5 (101 to 401) |
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.
| ng/mL | KW-0761 |
|---|---|
| Cmax | 42943.2 ± 14239.5 |
| Ctrough | 33638.3 ± 10572.2 |
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.
| ng·h/mL | KW-0761 |
|---|---|
| Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days) | 6297408 ± 1812467 |
| hours | KW-0761 |
|---|---|
| Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2) | 422 ± 147 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| KW-0761 | — | 6/27 (22.2%) | 27/27 (100%) |
| Event | KW-0761 |
|---|---|
| RashSkin and subcutaneous tissue disorders | 4/27 |
| Stevens-Johnson syndromeSkin and subcutaneous tissue disorders | 1/27 |
| PharyngitisInfections and infestations | 1/27 |
| Event | KW-0761 |
|---|---|
| Lymphocyte count decreasedInvestigations | 26/27 |
| Infusion related reactionGeneral disorders | 24/27 |
| PyrexiaGeneral disorders | 23/27 |
| White blood cell count decreasedInvestigations | 18/27 |
| ChillsGeneral disorders | 16/27 |
| Neutrophil count decreasedInvestigations | 14/27 |
| Platelet count decreasedInvestigations | 14/27 |
| Alanine aminotransferase increasedInvestigations | 11/27 |
| Aspartate aminotransferase increasedInvestigations | 11/27 |
| Blood lactate dehydrogenase increasedInvestigations | 10/27 |
| Age, Continuous(years) | KW-0761 |
|---|---|
| Median | 64 ± 7.5 |
| Sex: Female, Male(Participants) | KW-0761 |
|---|---|
| Female | 15 |
| Male | 12 |
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Kyowa Kirin Co., Ltd.