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

NCT ID: NCT01226472

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-09-30

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.

Conditions

Peripheral T-cell Lymphoma; Cutaneous T-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KW-0761

Group Type: EXPERIMENTAL

KW-0761

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Hakko Kirin Pharma, Inc.

INDUSTRY

Sponsor Role: collaborator

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Kurman, M.D.

Role: STUDY_DIRECTOR

Kyowa Hakko Kirin Pharma, Inc.

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

KW-0761-002

Identifier Type: -

Identifier Source: org_study_id