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

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.

Recruiting

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Key information

Conditions

Leukemia/Lymphoma ATLL Cutaneous T Cell Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CIBMTR

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Assess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combination

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jatin Jadwani, BDS, MSc Clinical Research

CONTACT

[email protected]

+49 15114861167

Linda J Burns, MD

CONTACT

[email protected]

414-805-0714

Sponsors and collaborators

Lead sponsor

Kyowa Kirin, Inc.

Industry

Registry information

Important dates

Study start: 2019
Primary completion: 2030
Study completion: 2030
First posted: Jul 10, 2019
Registry last updated: Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting