Actively Recruiting
Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab
Led by Kyowa Kirin, Inc. · Updated on 2024-07-24
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 Leukemia/Lymphoma (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.
CONDITIONS
Brief Title
Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients registered to the Center for International Blood and Marrow Transplant Research (CIBMTR)
- Adults 18 years of age or older with either Cutaneous T Cell Lymphoma (CTCL) or Adult T-cell Leukemia/Lymphoma (ATLL)
- Allogeneic hematopoietic stem cell transplantation (alloHCT) performed from January 2012 onward
You will not qualify if you...
- Patients without consent for research
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Retrospective
Baseline data are collected retrospectively for participants who have received mogamulizumab within one year before or up to 18 months after allogeneic hematopoietic stem cell transplantation (alloHCT).
1 baseline data collection
Duration - Up to 2 years post alloHCT
Participants are followed for safety and transplant-related outcomes with data collection at 100 days, 6 months, 1 year, and 2 years post alloHCT, including both retrospective and prospective data.
4 scheduled data collection points
Trial Site Locations
Total: 1 location
1
CIBMTR
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
L
Linda J Burns, MD
J
Jatin Jadwani, BDS, MSc Clinical Research
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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