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Open-Label Extension Study of Anti-CCR4 Monoclonal Antibody KW-0761 as Monotherapy in Subjects Who Relapsed After Complete Response on Study KW-0761-001

Phase 2
18 Years
Not Enrolling
Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma

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Trial Information

Open-Label Extension Study of Anti-CCR4 Monoclonal Antibody KW-0761 as Monotherapy in Subjects Who Relapsed After Complete Response on Study KW-0761-001

Inclusion Criteria:

- 1. The subject has relapsed after achieving a complete response to treatment with KW
0761 for PTCL or CTCL on study, KW-0761-001.

2. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status
score of < 2 at study entry.

3. The subject is >18 years of age. 4. The subject has adequate hematological
function: absolute neutrophil count [ANC] >1,500 cells/uL and platelets >100,000
cells/uL,except in patients with known bone marrow involvement where absolute
neutrophil count [ANC] must be > 1,000 cells/uL and platelets >75,000 cells/uL.

5. The subject has adequate hepatic function: bilirubin ≤ 1.5 times the specific
institutional upper limit of normal [ULN]; aspartate transaminase [AST] and alanine
transaminase [ALT] each ≤ 2.5 x ULN or ≤ 5.0 x ULN in the presence of known hepatic

6. The subject has serum creatinine ≤1.5 x ULN or a calculated creatinine clearance
>60 mL/min.

7. Subjects with MF and a history of staphylococcus colonization are eligible
provided they continue to receive stable doses of prophylactic antibiotics.

Exclusion Criteria:

1. The subject has received any type of treatment for their disease since completing
study, KW-0761-001.

2. The subject has a significant uncontrolled intercurrent illness including, but not
limited to: uncontrolled infection requiring antibiotics; clinically significant
cardiac disease (class III or IV of the New York Heart Association [NYHA]
classification); unstable angina pectoris; angioplasty, stenting, or myocardial
infarction within 6 months; uncontrolled hypertension (systolic blood pressure >160
mmHg, diastolic BP >100 mmHg, found on two consecutive measurements separated by a 1
week period) despite two anti-hypertensive medications; clinically significant
cardiac arrhythmia; or uncontrolled diabetes.

3. Subjects on any immunomodulatory drug, (other than low dose corticosteroids
equivalent to a daily dose of 10 mg of prednisone

4. The subject has a psychiatric illness, disability or social situation that would
compromise the subject's safety or ability to provide consent, or limit his or her
compliance with study requirements.

5. The subject has experienced allergic reactions to monoclonal antibodies or other
therapeutic proteins.

6. Subjects with active herpes simplex or herpes zoster.

7. Subjects with known autoimmune diseases

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine a Global Composite Response (skin, blood, lymph nodes)as determined by skin evaluations, blood counts and PET/CT imaging

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Michael Kurman, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Kyowa Hakko Kirin Pharma


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

September 2012

Related Keywords:

  • Peripheral T-cell Lymphoma
  • Cutaneous T-cell Lymphoma
  • PTCL
  • CTCL
  • MF
  • SS
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell, Peripheral



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