Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001
This study has been completed.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Pharma, Inc.
First received: October 19, 2010
Last updated: August 26, 2013
Last verified: August 2013
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 achieving a complete response in study, KW-0761-001.
Peripheral T-cell Lymphoma
Cutaneous T-cell Lymphoma
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- To determine a Global Composite Response (skin, blood, lymph nodes)as determined by skin evaluations, blood counts and PET/CT imaging [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine the number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2012 (Final data collection date for primary outcome measure)
In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226472
|Stanford, California, United States, 94305 |
Kyowa Hakko Kirin Pharma, Inc.
||Michael Kurman, M.D.
||Kyowa Hakko Kirin Pharma
No publications provided
||Kyowa Hakko Kirin Pharma, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 19, 2010
||August 26, 2013
||United States: Food and Drug Administration
Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Immune System Diseases