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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT00920790
First received: June 9, 2009
Last updated: August 24, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
Intervention Details:
    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.
    Other Name: Mogamulizumab
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Positive for serum anti-HTLV-I antibody
  2. Acute-, lymphoma-, or chronic-type with poor prognostic factors specified in the past
  3. Positive for CCR4
  4. Relapsed subject after the response (CR, CRu or PR) in the last previous chemotherapy
  5. Received at least one prior chemotherapy
  6. 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
  7. PS of 0 to 2
  8. Negative for HBs antigen and for HBV-DNA by a real-time PCR

Exclusion Criteria:

  1. A history of transplantation such as hematopoietic stem cells
  2. Positive for HCV antibody or HIV antibody
  3. Active multiple cancers at the time of starting this clinical study
  4. Previous history of allergic reactions after receiving antibody products
  5. Requiring continuous systemic treatment with a steroid
  6. Requiring such radiotherapy after starting this clinical study
  7. Treated with any investigational drug other than KW-0761 within three months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920790

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  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
Immune System Diseases
Immunoproliferative Disorders
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 22, 2014