NCT04974996

A Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated Diffuse Large B-cell Lymphoma (LOTIS-8)

A Phase 1b, Open-Label, Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Combination With R-CHOP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma (LOTIS-8)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ADC Therapeutics S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy, and identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for the combination therapy.

Detailed description

This is a Phase 1b, open-label, multi-center study in participants with previously untreated DLBCL, with a dose escalation part followed by dose expansion part. Participants will be treated by loncastuximab tesirine in combination with R CHOP. The duration of the study participation for each participant is defined as the time from the date of signed written informed consent to the completion of the follow-up period, withdrawal of consent, lost to follow-up, or death, whichever occurs first. The study will include a Screening Period (of up to 28 days), a Treatment Period of 6 cycles (cycles of 3 weeks), and a Follow-up Period (approximately every 12 week visits) for up to approximately 3 years from end-of-treatment (EOT).

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Loncastuximab tesirine	Intravenous (IV) infusion
DRUG	Prednisone	Orally via tablet or capsule
DRUG	Rituximab	Intravenous (IV) infusion
DRUG	Cyclophosphamide	Intravenous (IV) infusion
DRUG	Doxorubicin	Intravenous (IV) infusion
DRUG	Vincristine	Intravenous (IV) infusion

Timeline

• Start date: 2022-02-01
• Primary completion: 2024-03-11
• Completion: 2027-05-05
• First posted: 2021-07-23
• Last updated: 2022-03-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study