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

Recruiting

• Conditions: Leukemia/Lymphoma; ATLL; Cutaneous T Cell Lymphoma

• Registration Number: NCT04014374
• Lead Sponsor: Kyowa Kirin, Inc.

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.

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 Timeline

• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-09
• Study First Posted: 2019-07-10
• Study Start: 2019-09-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2030-02
• Study Completion: 2030-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

CIBMTR; 🇺🇸 Milwaukee, Wisconsin, United States