NCT01226472

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2010-10-22
• Last updated: 2024-04-25
• Results posted: 2020-12-29

Locations

1 site across 1 country: United States