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

Mantle Cell Lymphoma Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03684694
Study type Interventional
Source ADC Therapeutics S.A.
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date December 1, 2018
Completion date November 8, 2022
View Details
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