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Brief Title: A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)
Official Title: A Phase 2 Open-label Study of Loncastuximab Tesirine in Combination With Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Patients With Diffuse Large B-cell Lymphoma (DLBCL) (LOTIS-9)
Study ID: NCT05144009
Brief Summary: The main objective of the trial is to assess the efficacy and tolerability of Lonca-R in unfit and frail participants with previously untreated DLBCL.
Detailed Description: The primary objectives of this trial are shown below: Cohort A: To assess the efficacy of a response-adapted treatment of Lonca-R in unfit participants with previously untreated DLBCL, high-grade B cell lymphoma (HGBCL), or Grade 3b follicular lymphoma (FL). Cohort B: To assess the tolerability and efficacy of a response-adapted treatment of Lonca-R in frail participants with previously untreated DLBCL, or HGBCL, or Grade 3b FL who are ineligible for standard R-mini-CHOP. The simplified geriatric assessment (sGA) developed by the Fondazione Italiana Linfomi (FIL) identifies three distinct categories (fit, unfit, and frail) based on age, activities of daily living (ADL), instrumental activities of daily living (IADL) and the Cumulative Illness Rating Scale for Geriatrics (CIRS-G). Participants will be assigned to Cohort A (unfit) or B (frail) using the sGA.
Minimum Age: 80 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arizona Cancer Center, Tucson, Arizona, United States
Winthrop P. Rockefeller Cancer Institute, Little Rock, Arkansas, United States
Rocky Mountain Cancer Centers - Aurora, Aurora, Colorado, United States
USOR - Illinois Cancer Specialists - Niles, Niles, Illinois, United States
Leonard Lawson Cancer Center, Pikeville, Kentucky, United States
Cancer Care Specialists - Nevada, Reno, Nevada, United States
New York Cancer & Blood Specialists - New Hyde Park, Babylon, New York, United States
New York Cancer & Blood Specialists - Babylon Medical Oncology, Port Jefferson, New York, United States
Novant Health Cancer Specialists - Charlotte, Charlotte, North Carolina, United States
USOR - Oncology Hematology Care - Kenwood, Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Ohio Health - Research and Innovation Institute, Columbus, Ohio, United States
Willamette Valley Cancer Institute and Research Center - Eugene, Eugene, Oregon, United States
Reading Hospital - Tower Health, Reading, Pennsylvania, United States
Prisma Health Cancer Institute, Greenville, South Carolina, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Texas Oncology - Austin Midtown, Austin, Texas, United States
Texas Oncology - Medical City Dallas, Dallas, Texas, United States
USOR - Texas Oncology - Presbyterian Cancer Center Dallas, Dallas, Texas, United States
USOR - Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
USOR - Texas Oncology - San Antonio, San Antonio, Texas, United States
Texas Oncology Northeast Texas - Tyler, Tyler, Texas, United States
Blue Ridge Cancer Care - Blacksburg, Blacksburg, Virginia, United States
USOR - Virginia Cancer Specialists - Gainesville Office, Gainesville, Virginia, United States
Virginia Cancer Institute - West End, Richmond, Virginia, United States
USOR - Virginia Oncology Associates, Virginia Beach, Virginia, United States
Kadlec Clinic - Hematology and Oncology, Richland, Washington, United States
USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center, Vancouver, Washington, United States
Ospedaliera Santi Antonio E Biagio E Cesare Arrigo-SC Ematologia, Alessandria, , Italy
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia, Brescia, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, , Italy
Hospital Español Auxilio Mutuo, San Juan, , Puerto Rico
Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
Clinica Universidad de Navarra - Pamplona, Pamplona, Navarre, Spain
Hospital del Mar - Parc de Salut Mar, Barcelona, , Spain
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), Barcelona, , Spain
Hospital San Pedro de Alcantara, Cáceres, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Arnau de Vilanova, València, , Spain