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Phase II Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma

Phase 2
20 Years
Not Enrolling
Peripheral T/NK-cell Lymphoma

Thank you

Trial Information

Phase II Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma

Inclusion Criteria:

- Subjects with hematologically or pathohistologically diagnosed peripheral T/NK-cell

- Subjects who have been positive for CCR4

- Subjects who received one or more chemotherapy regimens

- Subjects who relapse after achieving complete response, uncertain complete response
or partial response by the last chemotherapy

- Subjects who have an interval of 4 weeks or more between the last day of the prior
therapy and the scheduled day of the first KW-0761 treatment

- Subjects with nodal lesions, extranodal lesions and/or cutaneous lesions

- Subjects who have a performance status of 0 to 2

- Subjects who are negative for HBs antigen and reported as "not detected" for HBV-DNA

- Subjects who are negative for anti-HCV antibody

- Subjects who have normal function of the major organs

- Subjects who have given written voluntary informed consent to participate in the

Exclusion Criteria:

- Subjects who underwent transplant therapy such as hematopoietic stem-cell
transplantation (Subjects who underwent autologous hematopoietic stem-cell
transplantation following chemotherapy will not be excluded)

- Subjects who are known carriers of HIV

- Subjects who have active multiple cancer

- Subjects who have a history of allergic reactions to therapeutic antibodies

- Subjects requiring continuous systemic treatment with steroid

- Subjects who require emergency radiotherapy for treating the symptoms caused by bulky
masses at enrollment or who may require such radiotherapy after the start of the

- Subjects who are pregnant, lactating or of childbearing potential, or who are
planning to have children

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Antitumor effect (best overall response)

Safety Issue:



Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

September 2010

Completion Date:

May 2012

Related Keywords:

  • Peripheral T/NK-cell Lymphoma
  • Lymphoma
  • Lymphoma, Extranodal NK-T-Cell