Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01226472
First received: October 19, 2010
Last updated: August 26, 2013
Last verified: August 2013

October 19, 2010
August 26, 2013
August 2010
September 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01226472 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peripheral T-cell Lymphoma
  • Cutaneous T-cell Lymphoma
Biological: KW-0761
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
September 2012
September 2012   (final data collection date for primary outcome measure)

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 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 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01226472
KW-0761-002
No
Kyowa Hakko Kirin Pharma, Inc.
Kyowa Hakko Kirin Pharma, Inc.
Not Provided
Study Director: Michael Kurman, M.D. Kyowa Hakko Kirin Pharma
Kyowa Hakko Kirin Pharma, Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP