NCT03684694

Safety and Efficacy Study of Loncastuximab Tesirine + Ibrutinib in Diffuse Large B-Cell or Mantle Cell Lymphoma

A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Loncastuximab Tesirine and Ibrutinib in Patients With Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma (LOTIS-3)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: ADC Therapeutics S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase 1/2 study is to evaluate the safety and efficacy of Loncastuximab Tesirine (ADCT-402) in combination with Ibrutinib in participants with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma.

Detailed description

The Phase 1 portion of the study will cover the dose escalation portion of the study. This will then be followed by the Phase 2 portion of the study, which will treat participants with the dose of loncastuximab tesirine determined in the Phase 1 portion of the study. The ibrutinib dose of 560 mg daily, will remain the same throughout both phases of the study. A standard 3+3 dose escalation design will be used for the Phase 1 portion of the study. The dose-limiting toxicity (DLT) period will be the 21 days following the first dose of ibrutinib. The dose escalation cohort will receive loncastuximab tesirine for 2 cycles with concurrent ibrutinib (concomitant therapy) and may then continue ibrutinib therapy up to one year. The Phase 2 portion of the study will involve 3 cohorts: * Non-germinal center B-cell diffuse large B-cell lymphoma (Non-GCB DLBCL) cohort * Germinal center B-cell diffuse large B-cell lymphoma (GCB DLBCL) cohort * Mantle cell lymphoma (MCL) cohort Each of the cohorts will be treated with the recommended dose of loncastuximab tesirine determined in the Phase 1 portion of the study. The study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 3 to 4 weeks), and a Follow-up Period (approximately every 12 week visits for up to 2 years after treatment discontinuation).

Conditions

• Diffuse Large B-Cell Lymphoma
• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Loncastuximab Tesirine	Intravenous (IV) infusion.
DRUG	Ibrutinib	Oral capsule.

Timeline

• Start date: 2018-12-01
• Primary completion: 2022-11-08
• Completion: 2022-11-08
• First posted: 2018-09-26
• Last updated: 2024-02-06
• Results posted: 2024-02-06

Locations

35 sites across 6 countries: United States, Belgium, France, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study