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

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Northside Hospital

Located in Atlanta, Georgia United States
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Washington University School of Medicine

Located in Saint Louis, Missouri United States
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Virginia Cancer Specialists, PC

Located in Fairfax, Virginia United States
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U.O. Oncologia ed Ematologia

Located in Rozzano, Milano Italy
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Anastasios Stathis

Located in Bellinzona, Canton Ticino Switzerland
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The Christie NHS Foundation Trust

Located in Manchester, England United Kingdom
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Sylvester Comprehensive Cancer Center

Located in Miami, FL United States
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Sidney Kimmel Cancer Center

Located in Philadelphia, PA United States
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Case Western Reserve University

Located in Cleveland, OH United States
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Hollings Cancer Center

Located in Charleston, SC United States
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Vista Oncology - West Olympia

Located in Olympia, WA United States
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City of Hope - Corona

Located in Duarte, CA United States
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Northwest Georgia Oncology Centers

Located in Marietta, GA United States
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Miami Cancer Institute

Located in Miami, FL United States
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Compassionate Cancer Care - Fountain Valley

Located in Fountain Valley, CA United States
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Iowa Oncology Research Association

Located in Des Moines, IA United States
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Oxford University Hospitals NHS Foundation Trust

Located in Oxford, ENGLAND UNITED KINGDOM
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NHS Greater Glasgow and Clyde

Located in Glasgow, SCOTLAND UNITED KINGDOM
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Nottingham University Hospitals NHS Trust

Located in Nottingham, ENGLAND UNITED KINGDOM
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Policlinico Sant'Orsola Malpighi

Located in Bologna, BOLOGNA ITALY
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North Shore Hematology Oncology Associates

Located in East Setauket, NY United States
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Recruitment Status: Open


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