Last updated on March 2019

Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Brief description of study

The purpose of this Phase 2 study is to evaluate the clinical efficacy and safety of Loncastuximab Tesirine (ADCT-402) in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma.


Detailed Study Description

This is a Phase 2, multi-center, open-label, single-arm study of the efficacy and safety of loncastuximab tesirine used as monotherapy in patients with relapsed or refractory DLBCL. The study will enroll approximately 140 patients.

Loncastuximab Tesirine is an antibody drug conjugate (ADC) composed of a humanized antibody directed against human cluster of differentiation 19 (CD19), stochastically conjugated via a valine-alanine cleavable, maleimide linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Loncastuximab tesirine has been designed to target and kill CD19-expressing malignant B-cells.

A 2-stage design will be used in this clinical study, 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.

For each patient, the study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 3 weeks), and a Follow-up Period (approximately every 12 week visits for up to 3 years after treatment discontinuation).

Patients may continue treatment until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurs first.


Clinical Study Identifier: TX216182

Find a site near you

Start Over

Northside Hospital

Located in Atlanta, Georgia United States
  Connect »

Washington University School of Medicine

Located in Saint Louis, Missouri United States
  Connect »

Virginia Cancer Specialists, PC

Located in Fairfax, Virginia United States
  Connect »

U.O. Oncologia ed Ematologia

Located in Rozzano, Milano Italy
  Connect »

Anastasios Stathis

Located in Bellinzona, Canton Ticino Switzerland
  Connect »

The Christie NHS Foundation Trust

Located in Manchester, England United Kingdom
  Connect »

Sylvester Comprehensive Cancer Center

Located in Miami, FL United States
  Connect »

Sidney Kimmel Cancer Center

Located in Philadelphia, PA United States
  Connect »

Case Western Reserve University

Located in Cleveland, OH United States
  Connect »

Hollings Cancer Center

Located in Charleston, SC United States
  Connect »

Vista Oncology - West Olympia

Located in Olympia, WA United States
  Connect »

City of Hope - Corona

Located in Duarte, CA United States
  Connect »

Northwest Georgia Oncology Centers

Located in Marietta, GA United States
  Connect »

Miami Cancer Institute

Located in Miami, FL United States
  Connect »

Compassionate Cancer Care - Fountain Valley

Located in Fountain Valley, CA United States
  Connect »

Iowa Oncology Research Association

Located in Des Moines, IA United States
  Connect »

Oxford University Hospitals NHS Foundation Trust

  Connect »

NHS Greater Glasgow and Clyde

  Connect »

Nottingham University Hospitals NHS Trust

Located in Nottingham, ENGLAND UNITED KINGDOM
  Connect »

Policlinico Sant'Orsola Malpighi

Located in Bologna, BOLOGNA ITALY
  Connect »

North Shore Hematology Oncology Associates

Located in East Setauket, NY United States
  Connect »

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.