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Completed

NCT Number: NCT00920790

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

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.

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Key information

Conditions

Adult T-Cell Leukemia-Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KW-0761

Biological

KW-0761 is administered weekly for 8 weeks as an intravenous infusion of 2 hours at a dose of 1.0 mg/kg.

Other names: Mogamulizumab

Primary outcomes

  1. 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.

  2. 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.

  3. Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days)

    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.

  4. 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 outcomes

  1. 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).

  2. Overall Survival (OS)

    Time frame: Baseline to response

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

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 15, 2009
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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