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NCT04014374 Clinical Trial

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

Cutaneous T Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04014374
Other study ID # SC18-09
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 10, 2019
Est. completion date February 2030

Study information
Verified date February 2024
Source Kyowa Kirin, Inc.
Contact Linda J Burns, MD
Phone 414-805-0714
Email lburns@mcw.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date February 2030
Est. primary completion date February 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States CIBMTR Milwaukee Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
Kyowa Kirin, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combination 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. one year prior to alloHCT to within 18 months after alloHCT
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