Safety Study of Allogeneic Stem Cell Transplant in Adults with CTCL or ATLL Treated with Mogamulizumab

What this Trial Is About

This research aims to evaluate non-relapse mortality and treatment-related toxicities in adult patients with Cutaneous T Cell Lymphoma CTCL or Adult T-cell LeukemiaLymphoma ATLL who have undergone allogeneic hematopoietic stem cell transplantation alloHCT. It focuses on patients treated with the drug mogamulizumab either before or after transplantation, studying outcomes in those transplanted from January 1, 2012 onwards. The study is observational, collecting data both retrospectively and prospectively to understand safety after treatment. Participants include those who received mogamulizumab within one year before or up to 18 months after alloHCT, as well as a control group of patients who had alloHCT without mogamulizumab exposure. Data collection occurs at baseline retrospectively, and at 100 days, 6 months, 1 year, and 2 years post-transplant. The follow-up period is designed to allow at least 6 months of monitoring within two years after alloHCT. During the study, researchers will collect clinical data to assess transplant-related toxicities or complications among patients treated with mogamulizumab alone or in combination. The study involves regular reviews of medical outcomes at specified intervals to evaluate safety. Participation duration varies depending on when patients received transplantation and drug exposure, with monitoring continuing until study accrual is complete.

Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab