Spots Global Cancer Trial Database for A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
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Trial Identification
Brief Title: A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
Official Title: A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
Study ID: NCT04970901
Study Description
Brief Summary: The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab, and to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for the combinations.
Detailed Description: This is a Phase 1b, multi-center, open-label, multi-arm study to evaluate the safety and anti-cancer activity of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab in participants with relapsed or refractory B-cell Non-Hodgkin Lymphoma (R/R B-NHL). The study will enroll approximately 200 participants. Loncastuximab tesirine (ADCT-402; Zynlonta) is an antibody drug conjugate (ADC), composed of a humanized monoclonal antibody directed against human cluster of differentiation 19 (CD19) conjugated through a cathepsin-cleavable linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Loncastuximab tesirine has been granted by Food and Drug Administration (FDA) as accelerated approval for adult participants with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma (HGBCL). In the European Union (EU), the European Commission (EC) granted conditional approval for the treatment of adult patients with relapsed or refractory DLBCL and HGBCL, after two or more lines of systemic therapy. The study includes multiple arms in two parts, Dose Escalation part (Part 1) and Dose Expansion part (Part 2). In Part 1, for the arm of loncastuximab tesirine in combination with polatuzumab vedotin includes DLBCL, HGBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and Burkitt lymphoma (BL); for the arms of loncastuximab tesirine in combination with glofitamab or mosunetuzumab include DLBCL, HGBCL, FL, and MZL. In Part 2, participants will be treated at the dose level determined from Part 1. The Sponsor will conduct the safety monitoring and the overall supervision of the study in consultation with the Dose-Escalation Steering Committee (DESC). For each participant, the study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 21 days), and a Follow-up Period (approximately every 12 week visits for up to two years). Participants may continue treatment for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurs first. Treatment with gemcitabine (Arm A), lenalidomide (Arm B), and umbralisib (Arm D) were removed.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
Memorial Cancer Institute - Memorial Hospital West, Pembroke Pines, Florida, United States
The Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States
University of Minnesota, Minneapolis, Minnesota, United States
Oregon Health and Science University, Portland, Oregon, United States
Hollings Cancer Center, Charleston, South Carolina, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Emily Couric Clinical Cancer Center, Charlottesville, Virginia, United States
NEXT Virginia (Virginia Cancer Specialists), Fairfax, Virginia, United States
Universitair Ziekenhuis Gent, Gent, , Belgium
Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne, Yvoir, , Belgium
Fakultni Nemocnice Brno, Brno, South Moravian, Czechia
Fakultni nemocnice Ostrava, Ostrava, , Czechia
Fakultní Nemocnice Královské Vinohrady, Prague, , Czechia
Fakultni nemocnice v Motole, Prague, , Czechia
Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII, Bergamo, , Italy
Centro di Ricerche Cliniche - IRCCS Azienda Ospedaliero Universitaria di Bologna, Bologna, , Italy
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia, Brescia, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), Barcelona, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Complejo Asistencial Universitario de Salamanca - Hospital Clínico, Salamanca, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom
Contact Details
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