Spots Global Cancer Trial Database for Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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Trial Identification
Brief Title: Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Official 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) (LOTIS-2)
Study ID: NCT03589469
Interventions
Study Description
Brief Summary: 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 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 through a cathepsin-cleavable linker to SG3199, 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte, California, United States
Compassionate Care Research Group, Inc., at Compassionate Care Medical Group, Inc., Fountain Valley, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
University of California, San Francisco Medical Center, San Francisco, California, United States
The Oncology Institute of Hope and Innovation, Whittier, California, United States
University of Miami Hospital and Clinics, Miami, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Northside Hospital, Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, PC-Drug Shipment, Lab and Study Supplies Only, Marietta, Georgia, United States
Medical Oncology & Hematology Associates, Des Moines, Iowa, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
University of Nebraska Medical Center/ Nebraska Medicine, Omaha, Nebraska, United States
North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists, East Setauket, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Hollings Cancer Center, Charleston, South Carolina, United States
GHD Cancer Institute, Greenville, South Carolina, United States
Baylor University Medical Center, Dallas, Texas, United States
Baylor Scott & White Medical Center - Temple, Temple, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Vista Oncology Inc. PS, Olympia, Washington, United States
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
A.O. SS Antonio e Biagio e Cesare Arrigo, Alessandria, AL, Italy
Istituto di Ematologia Seragnoli, Bologna, BO, Italy
U.O. Oncologia ed Ematologia, Rozzano, Milano, Italy
Dipartimento di Oncomatlolgia - Unita Linfomi, Milano, , Italy
Divisione di Oncoematologia, Milano, , Italy
Anastasios Stathis, Bellinzona, Canton Ticino, Switzerland
University Hospitals of Leicester NHS Trust., Leicester, England, United Kingdom
University College London Hospital, London, England, United Kingdom
The Christie NHS Foundation Trust, Manchester, England, United Kingdom
Oxford Cancer Centre, Churchill Hospital, Oxford, England, United Kingdom
NHS Greater Glasgow and Clyde, Glasgow, Scotland, United Kingdom
Abertawe Bro Morgannwg University Health Board - Singleton Hospital, Swansea, Wales, United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Contact Details
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