Evaluating Loncastuximab Tesirine for Lymphoma Patients with Liver Issues
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)
This study is testing how safe and effective a new lymphoma treatment is for patients with liver problems to find the right dose for them.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ADC Therapeutics S.A. Industry-sponsored |
| Drugs / interventions | loncastuximab, chemotherapy |
| Locations | 14 sites (Lynwood, California and 13 other locations) |
| Trial ID | NCT05660395 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the pharmacokinetics and safety of loncastuximab tesirine in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) who also have moderate to severe hepatic impairment. Participants will be categorized based on their liver function and receive the treatment accordingly. The primary goal is to determine the appropriate dosing regimen for these patients, ensuring safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with relapsed or refractory DLBCL or HGBCL and varying degrees of hepatic impairment.
Not a fit: Patients with stable liver function or those who have not received prior systemic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a tailored treatment option for lymphoma patients with liver impairment, improving their outcomes.
How similar studies have performed: While there have been studies on loncastuximab tesirine, this specific focus on patients with hepatic impairment is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female participants aged 18 years or older * Pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) DLBCL not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma (2016 World Health Organization classification) who have received at least one systemic treatment regimen * Measurable disease as defined by the 2014 Lugano Classification * Normal hepatic function or hepatic impairment as defined by the National Cancer Institute Organ Dysfunction Working Group hepatic impairment classification: * Arm A Normal hepatic function: bilirubin and aspartate aminotransferase (AST) ≤ upper limit of normal (ULN) * Arm B Moderate hepatic impairment: bilirubin \> 1.5 × to 3 × ULN (any AST) * Arm C Severe hepatic impairment: bilirubin \> 3 × ULN (any AST) * ECOG performance status 0 to 2 for participants with normal hepatic function. ECOG 0 to 3 for participants with moderate or severe hepatic impairment * Adequate organ function * Women of childbearing potential (WOCBP)\* must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of study drug. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of the first dose until at least 7 months after the last dose of study drug. Exclusion Criteria: * Previous therapy with loncastuximab tesirine * Allogenic or autologous stem cell transplant within 60 days prior to start of study drug (C1D1) * Human immunodeficiency virus (HIV) seropositive * Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load * Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load * History of Stevens-Johnson syndrome or toxic epidermal necrolysis * Lymphoma with active central nervous system involvement at the time of screening, including leptomeningeal disease * Breastfeeding or pregnant * Significant medical comorbidities * Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor
Where this trial is running
Lynwood, California and 13 other locations
- The Oncology Institute of Hope & Innovation - Lynwood — Lynwood, California, United States (Completed)
- Hospital Sírio-Libanês - Brasília — Brasília, Brazil (Recruiting)
- Hospital Mãe de Deus - Centro Integrado de Oncologia — Porto Alegre, Brazil (Recruiting)
- Hospital Sírio-Libanês - São Paulo — São Paulo, Brazil (Recruiting)
- A Beneficência Portuguesa de São Paulo - Unidade Mirant — São Paulo, Brazil (Recruiting)
- Hospital 9 de Julho — São Paulo, Brazil (Recruiting)
- Albert Einstein Israelite Hospital — São Paulo, Brazil (Recruiting)
- Kyungpook National University Chilgok Hospital — Daegu, Daegu Gwang'yeogsi, South Korea (Recruiting)
- Dong-A University Hospital — Pusan, Gyeongsangnam-do, South Korea (Recruiting)
- Korea University Anam Hospital — Seoul, Seongbuk District, South Korea (Active_not_recruiting)
- Seoul National University Hospital — Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea (Recruiting)
- Severance Hospital — Seoul, Seoul Teugbyeolsi, South Korea (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
- Koo Foundation Sun Yat-Sen Cancer Center — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: ADC Therapeutics
- Email: clinical.trials@adctherapeutics.com
- Phone: 954-903-7994
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.