Mogamulizumab Q4week dosing in Participants with R/R CTCL
Research type
Research Study
Full 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)
IRAS ID
1003660
Contact name
Lisa Perry
Contact email
Sponsor organisation
Kyowa Kirin Inc.
Eudract number
2020-004537-20
Clinicaltrials.gov Identifier
Research summary
Mogamulizumab is an approved medicine for the treatment of patients with mycoses fungoides (MF) and Sézary syndrome (SS), which are a type of non-Hodgkin lymphoma, who have received at least one prior therapy (by mouth or by infusion in a vein). The current approved treatment schedule for Mogamulizumab is an infusion four times in a 28-day initial cycle followed by further infusions fortnightly. While this schedule has been shown as an effective treatment, it is inconvenient and can have a huge impact when unforeseen circumstances, such as the COVID-19 pandemic, further limit accessibility to treatment. Therefore, this clinical trial will change the treatment schedule of Mogamulizumab to be given once every four weeks after the initial treatment cycle, and assess the resulting safety, and effectiveness.
Up to 33 participants will take part in the study across North America, Europe and the UK. The maximum treatment time in the study is for two years. Participants in the study will undergo medical tests and procedures prior to receiving Mogamulizumab to make sure they are suitable for the study. Safety and tolerability will be assessed through reported adverse events (AEs), changes in physical examinations, vital sign measurements, electrocardiograms, and laboratory analyses. Participants will have blood samples taken to measure how the amount of Mogamulizumab changes over time.
REC name
Wales REC 1
REC reference
21/WA/0236
Date of REC Opinion
24 Sep 2021
REC opinion
Further Information Favourable Opinion