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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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.
City of Hope National Medical Center
Duarte, California, United States
University of California Irvine
Irvine, California, United States
Number, percentage and severity of treatment emergent adverse events
Adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (v. 5.0).
Time frame: From date of consent, at every treatment and follow up visit, up to 27 months
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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
...and 6 more locations