Clinical Trial: Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Clinical Study of KW-0761 in Patients With CCR4-Positive Adult T-cell Leukemia-Lymphoma

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.

Detailed Summary:
Sponsor: Kyowa Hakko Kirin Co., Ltd

Current Primary Outcome:

  • 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. ]

    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 ]

    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 ]
    Statistics of plasma KW-0761 concentrations were tabula

    Original Primary Outcome: Best response: a subject diagnosed as having complete response (CR), CR/unconfirmed (CRu) or partial response (PR) in the best overall response is considered a responder in accordance with the applicable criteria.

    Current Secondary Outcome:

    • Progression Free Survival (PFS) [ Time Frame: Baseline to response ]

      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 ]
      The time from the date of first KW-0761 dosing to the date of death.


    Original Secondary Outcome:

    • Best response in each legion: the best response in the peripheral blood and the lesions other than peripheral blood in the lesions are determined in accordance with the applicable criteria.
    • Progression free survival and overall survival
    • Plasma KW-0761 concentrations and pharmacokinetic parameters
    • Adverse events, related adverse events and expression of anti-KW-0761 antibody


    Information By: Kyowa Hakko Kirin Co., Ltd

    Dates:
    Date Received: June 9, 2009
    Date Started: June 2009
    Date Completion:
    Last Updated: February 28, 2017
    Last Verified: February 2017