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A Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)
Sponsor: ADC Therapeutics S.A.
Summary
The primary objective of this study is to determine the recommended dosing regimen of loncastuximab tesirine in diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) participants with moderate and severe hepatic impairment.
Official title: A Phase 1b Open-Label Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2023-08-28
Completion Date
2027-04-05
Last Updated
2025-07-16
Healthy Volunteers
No
Interventions
Loncastuximab Tesirine
Intravenous (IV) Infusion
Locations (14)
The Oncology Institute of Hope & Innovation - Lynwood
Lynwood, California, United States
Hospital Sírio-Libanês - Brasília
Brasília, Brazil
Hospital Mãe de Deus - Centro Integrado de Oncologia
Porto Alegre, Brazil
Hospital Sírio-Libanês - São Paulo
São Paulo, Brazil
A Beneficência Portuguesa de São Paulo - Unidade Mirant
São Paulo, Brazil
Hospital 9 de Julho
São Paulo, Brazil
Albert Einstein Israelite Hospital
São Paulo, Brazil
Kyungpook National University Chilgok Hospital
Daegu, Daegu Gwang'yeogsi, South Korea
Dong-A University Hospital
Pusan, Gyeongsangnam-do, South Korea
Korea University Anam Hospital
Seoul, Seongbuk District, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea
Severance Hospital
Seoul, Seoul Teugbyeolsi, South Korea
National Taiwan University Hospital
Taipei, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan