Sponsor: ADC Therapeutics SA
Sponsor Study ID: ADCT-402-201
Study Title: A Phase 2 Open Label Single Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
CTO #: 102905
NCT Number: NCT03589469
Phase: II
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Non-Hodgkin's Lymphoma
Study Objectives: This is a Phase 2, multi-center, open-label, single-arm study. The study will enroll approximately 140 patients. A 2-stage design will be used, with an interim analysis for futility on the first 52 patients. If =10 patients respond (CR+PR), the study will proceed to complete full enrollment. Enrollment will continue during the interim analysis; however, further enrollment will be halted if futility is confirmed.