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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 July 24, 2014
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs