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

NCT01226472 | Completed Phase 2 Results

• 1 other identifier: KW-0761-002
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Keywords

PTCL; CTCL; MF; SS

Outcome Measures

Primary Outcomes (1)

• Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging

  one year

Secondary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability.

  one year

Study Arms (1)

KW-0761

EXPERIMENTAL

Biological: KW-0761

Interventions

KW-0761 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.

KW-0761

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. The subject has relapsed after achieving a complete response to treatment with KW 0761 for PTCL or CTCL on study, KW-0761-001.
• \. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of \< 2 at study entry.
• \. 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.
• \. 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.
• \. The subject has serum creatinine ≤1.5 x ULN or a calculated creatinine clearance \>60 mL/min.
• \. Subjects with MF and a history of staphylococcus colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead
• Kyowa Hakko Kirin Pharma, Inc.: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous

Interventions

mogamulizumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Kyowa Kirin Pharmaceutical Development
• Organization: Kyowa Kirin Pharmaceutical Development

kkd.clintrial.82@kyowakirin.com

609-919-1100

Study Officials

• Michael Kurman, M.D.

  Kyowa Hakko Kirin Pharma, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 22, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 25, 2024
• Results First Posted: December 29, 2020

Record last verified: 2024-04

Locations

US (1)