Actively Recruiting
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)
Led by ADC Therapeutics S.A. · Updated on 2025-07-16
56
Participants Needed
14
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older
- Diagnosis of relapsed or refractory diffuse large B-cell lymphoma or high-grade B-cell lymphoma with at least one prior systemic treatment
- Measurable disease according to the 2014 Lugano Classification
- Normal liver function or moderate to severe hepatic impairment as defined by bilirubin and AST levels
- ECOG performance status 0 to 2 for normal liver function, 0 to 3 for moderate or severe hepatic impairment
- Adequate organ function
- Women of childbearing potential must agree to use effective contraception from consent until 10 months after last dose; men with female partners of childbearing potential must use condoms or abstain from first dose until 7 months after last dose
You will not qualify if you...
- Previous treatment with loncastuximab tesirine
- Stem cell transplant within 60 days prior to study start
- HIV positive
- Chronic hepatitis B infection without or unwilling to receive antiviral therapy or with detectable viral load
- Hepatitis C infection without curative treatment or with detectable viral load
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis
- Active central nervous system lymphoma involvement
- Pregnant or breastfeeding
- Significant medical comorbidities
- Major surgery, radiotherapy, chemotherapy, or other anti-cancer therapy within 14 days prior to study start unless approved by Sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
The Oncology Institute of Hope & Innovation - Lynwood
Lynwood, California, United States, 90262
Completed
2
Hospital Sírio-Libanês - Brasília
Brasília, Brazil, 70200-730
Actively Recruiting
3
Hospital Mãe de Deus - Centro Integrado de Oncologia
Porto Alegre, Brazil, 90110-270
Actively Recruiting
4
Hospital Sírio-Libanês - São Paulo
São Paulo, Brazil, 01308-050
Actively Recruiting
5
A Beneficência Portuguesa de São Paulo - Unidade Mirant
São Paulo, Brazil, 01323-030
Actively Recruiting
6
Hospital 9 de Julho
São Paulo, Brazil, 01409-002
Actively Recruiting
7
Albert Einstein Israelite Hospital
São Paulo, Brazil, 05652-900
Actively Recruiting
8
Kyungpook National University Chilgok Hospital
Daegu, Daegu Gwang'yeogsi, South Korea, 41944
Actively Recruiting
9
Dong-A University Hospital
Pusan, Gyeongsangnam-do, South Korea, 602-812
Actively Recruiting
10
Korea University Anam Hospital
Seoul, Seongbuk District, South Korea, 02841
Active, Not Recruiting
11
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 03080
Actively Recruiting
12
Severance Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
13
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
14
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan, Taiwan 112
Actively Recruiting
Research Team
A
ADC Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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