Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab
Study Details
Study Description
Brief Summary
This is a non-interventional cohort study evaluating non-relapse mortality and toxicities in patients with CTCL or ATLL treated with mogamulizumab pre- or post- alloHCT for patients transplanted beginning January 1, 2012 until accrual is complete.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
This is an observational, retrospective and prospective study where subjects who have received mogamulizumab either within one year before or within 18 months after transplantation will be followed for data collection. Data will be collected at baseline (retrospectively), 100 days post alloHCT, 6-months, 1 year and at 2 years post alloHCT (retrospectively and prospectively).
A cut-off time limit of 18 months post alloHCT exposure will allow at least 6 months of follow-up within the 2 years post-alloHCT follow-up period.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Transplant Arm Patients with CTCL or ATLL who received mogamulizumab within one year prior or up to 18 months after alloHCT |
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Control Arm Patients who have undergone alloHCT without exposure to mogamulizumab pre- or post-alloHCT |
Outcome Measures
Primary Outcome Measures
- Assess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combination [one year prior to alloHCT to within 18 months after alloHCT]
This study will utilize comprehensive report form (CRF) data, modified transplant essential data (TED) and supplemental data. In patients with only TED data the supplemental data will provide the required additional information for data analyses to meet the objectives of the study.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients registered to the Center for International Blood and Marrow Transplant Research (CIBMTR)
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Adults ≥18 years of age with either CTCL or ATLL;
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AlloHCT performed from January 2012 onward.
Exclusion Criteria:
• Patients without consent for research.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | CIBMTR | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Kyowa Kirin, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SC18-09