Trials / Active Not Recruiting
Active Not RecruitingNCT04384484
Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
A Phase 3 Randomized Study of Loncastuximab Tesirine Combined With Rituximab Versus Immunochemotherapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 440 (actual)
- Sponsor
- ADC Therapeutics S.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy of loncastuximab tesirine (ADCT-402) combined with rituximab compared to standard immunochemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Loncastuximab Tesirine | Intravenous Infusion |
| DRUG | Rituximab | Intravenous Infusion |
| DRUG | Gemcitabine | Intravenous Infusion |
| DRUG | Oxaliplatin | Intravenous Infusion |
Timeline
- Start date
- 2020-09-16
- Primary completion
- 2026-03-31
- Completion
- 2028-06-30
- First posted
- 2020-05-12
- Last updated
- 2026-03-24
Locations
144 sites across 21 countries: United States, Argentina, Belgium, Brazil, Canada, Chile, China, Czechia, France, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04384484. Inclusion in this directory is not an endorsement.