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Mogamulizumab Q4week Dosing in Participants With R/R CTCL
Sponsor: Kyowa Kirin, Inc.
Summary
This is an open-label, multicenter, Phase 2 study to evaluate the safety and tolerability of mogamulizumab given Q4W following initial weekly induction in adult participants with relapsed/refractory MF and SS subtypes of CTCL. The study is composed of a 28-day Screening Period during which participants are screened for entry into this study, followed by a treatment period of up to 2 years from Cycle 1 Day 1.
Official title: Open-Label, Phase 2 Study to Assess the Safety of Mogamulizumab Given Every 4 Weeks Following Induction in Participants With Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2021-08-16
Completion Date
2025-05
Last Updated
2024-04-25
Healthy Volunteers
No
Interventions
Mogamulizumab
For the first 28-day induction cycle (C1), mogamulizumab 1 mg/kg will be administered as an IV infusion through a 0.22- or 0.2-μm in-line filter over at least 60 minutes on Days 1, 8, 15, and 22. For all subsequent 28-day cycles (C2, 3, 4, etc.), mogamulizumab 2 mg/kg will be administered as an IV infusion over at least 60 minutes on Day 1 of each subsequent therapy cycle.
Locations (16)
City of Hope National Medical Center
Duarte, California, United States
University of California Irvine
Irvine, California, United States
Stanford Cancer Center
Stanford, California, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
New York Presbyterian Hospital
New York, New York, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Hôpital Saint Louis
Paris, France
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Italy
Hospital del Mar
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario De Salamanca
Salamanca, Spain
Queen Elizabeth Hospital
Birmingham, United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom