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

Phase 2
20 Years
Not Enrolling
Adult T-cell Leukemia-lymphoma

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Trial Information

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

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate (ORR)

Outcome Description:

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.

Outcome 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.

Safety Issue:



Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

June 2009

Completion Date:

November 2010

Related Keywords:

  • Adult T-cell Leukemia-lymphoma
  • Leukemia
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma