Evaluating safety in patients with leukemia or lymphoma treated with mogamulizumab after stem cell transplantation
Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab
This study is trying to see how safe the drug mogamulizumab is for people with certain types of leukemia or lymphoma after they have a stem cell transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kyowa Kirin Co., Ltd. Industry-sponsored |
| Drugs / interventions | mogamulizumab |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT04014374 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to assess non-relapse mortality and toxicities in patients with cutaneous T cell lymphoma (CTCL) or adult T cell leukemia/lymphoma (ATLL) who have been treated with mogamulizumab around the time of allogeneic hematopoietic stem cell transplantation (alloHCT). Participants will be followed for data collection at various time points, including baseline, 100 days, 6 months, 1 year, and 2 years post-transplant. The study will include both retrospective and prospective data collection to evaluate the safety profile of mogamulizumab in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of CTCL or ATLL who have undergone alloHCT since January 2012.
Not a fit: Patients who do not consent to participate in the research will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and mortality risks associated with mogamulizumab in patients undergoing stem cell transplantation.
How similar studies have performed: While this study focuses on a specific treatment and patient population, similar observational studies have provided valuable safety data in hematopoietic stem cell transplantation, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients registered to the Center for International Blood and Marrow Transplant Research (CIBMTR) * Adults ≥18 years of age with either CTCL or ATLL; * AlloHCT performed from January 2012 onward. Exclusion Criteria: • Patients without consent for research.
Where this trial is running
Milwaukee, Wisconsin
- Cibmtr — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Linda J Burns, MD
- Email: lburns@mcw.edu
- Phone: 414-805-0714
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.