Status:
COMPLETED
Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Collaborating Sponsors:
Kyowa Hakko Kirin Pharma, Inc.
Conditions:
Peripheral T-cell Lymphoma
Cutaneous T-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will enroll subjects with either Peripheral T-Cell Lymphoma (PTCL) or Cutaneous T-Cell Lymphoma(CTCL),including mycosis fungoides (MF) and Sezary Syndrome (SS), who have relapsed after achi...
Eligibility Criteria
Inclusion
- 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 malignancy.
- 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
- The subject has received any type of treatment for their disease since completing study, KW-0761-001.
- 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.
- Subjects on any immunomodulatory drug, (other than low dose corticosteroids equivalent to a daily dose of 10 mg of prednisone
- 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.
- The subject has experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.
- Subjects with active herpes simplex or herpes zoster.
- Subjects with known autoimmune diseases
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01226472
Start Date
August 1 2010
End Date
September 1 2012
Last Update
April 25 2024
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305