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NCT05660395 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma, sponsored by ADC Therapeutics S.A..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 14
- Study locations
NCT05660395: Recruiting Phase 1 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma, sponsored by ADC Therapeutics S.A..
NCT05660395 is a Phase 1 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma that is actively recruiting participants, run by ADC Therapeutics S.A.. The registered enrollment target is 56 participants, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (74% lower). The trial reports 14 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05660395, a Phase 1 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma, is actively recruiting participants, sponsored by ADC Therapeutics S.A..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 14
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Loncastuximab Tesirine
Study Locations (14)
Other
- Hospital Sírio-Libanês - Brasília - Brasília
- Hospital Mãe de Deus - Centro Integrado de Oncologia - Porto Alegre
- Hospital Sírio-Libanês - São Paulo - São Paulo
- A Beneficência Portuguesa de São Paulo - Unidade Mirant - São Paulo
- Hospital 9 de Julho - São Paulo
- Albert Einstein Israelite Hospital - São Paulo
- National Taiwan University Hospital - Taipei
- Koo Foundation Sun Yat-Sen Cancer Center - Taipei
California
- The Oncology Institute of Hope & Innovation - Lynwood - Lynwood
Daegu Gwang'yeogsi
- Kyungpook National University Chilgok Hospital - Daegu
Gyeongsangnam-do
- Dong-A University Hospital - Pusan
Seongbuk District
- Korea University Anam Hospital - Seoul
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
- Seoul National University Hospital - Seoul
Seoul Teugbyeolsi
- Severance Hospital - Seoul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2023-08-28 |
| Est. Completion | 2027-04-05 |
| Phase | Phase 1 |
What NCT05660395 shows while recruiting
NCT05660395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (74% lower).
The record links to 2 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Loncastuximab Tesirine is the first listed.
NCT05660395 lists 14 locations in 7 states (Other, California, Daegu Gwang'yeogsi).
Frequently Asked Questions
What is clinical trial NCT05660395 about?
NCT05660395 is a clinical study titled "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)". 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.
What is the current status of trial NCT05660395?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2023-08-28. Estimated completion is 2027-04-05.
What conditions does trial NCT05660395 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, High Grade B-Cell Lymphoma.
What interventions are being tested in trial NCT05660395?
The interventions under investigation include: Loncastuximab Tesirine (DRUG).
Who is sponsoring clinical trial NCT05660395?
This trial is sponsored by ADC Therapeutics S.A., which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05660395 being conducted?
This trial has 14 study locations across California, Daegu Gwang'yeogsi, Gyeongsangnam-do, Seongbuk District, Seoul Teugbyeolsi [Seoul-T'ukpyolshi]. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05660395's enrollment target sits among peer trials
56 55th of 114 higher than 60 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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