Clinical trial NCT01226472: Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral T-cell Lymphoma
Cutaneous T-cell Lymphoma
Keywords: PTCL
CTCL
MF
SS
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Hakko Kirin Pharma, Inc.
First posted: 2010-10-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 achieving a complete response in study, KW-0761-001.


Eligibility criteria: 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

Primary outcomes:
measure: Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging
timeFrame: one year
Secondary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability.
timeFrame: one year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Kyowa Hakko Kirin Pharma, Inc.
name: Michael Kurman, M.D.
role: STUDY_DIRECTOR
References: