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Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04974996
Study type Interventional
Source ADC Therapeutics S.A.
Contact
Status Withdrawn
Phase Phase 1
Start date February 1, 2022
Completion date May 5, 2027

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