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NCT04014374Recruiting

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

Kyowa Kirin, Inc.

Start Date

9/10/2019

Completion Date

2/1/2030

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

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Conditions

Leukemia/LymphomaCutaneous T Cell LymphomaATLL

Locations

CIBMTR

Milwaukee, Wisconsin 53226

United States