Spots Global Cancer Trial Database for A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation
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Trial Identification
Brief Title: A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation
Official Title: A Prospective, Open-Label, Multicenter Randomized Phase III Study to Compare The Efficacy and Safety of A Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/Bendamustine and Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL(17P) or TP53 Mutation
Study ID: NCT04285567
Conditions
Study Description
Brief Summary: This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale \[CIRS\]/score of ≤6 and a normal creatinine clearance of ≥70 mL/min) with previously untreated CLL without DEL(17P) or TP53 mutation requiring treatment. Eligible participants will be randomly assigned in a 1:1 ratio to receive either VEN + G (Arm A) or FCR/BR (Arm B).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medical Center of Aurora; Rocky Mountain Cancer Centers, Aurora, Colorado, United States
Center For Cancer and Blood Disorders, Bethesda, Maryland, United States
Maryland Oncology Hematology, P.A., Columbia, Maryland, United States
St. Vincent Frontier Cancer Center, Billings, Montana, United States
University of Tennessee Medical Center, Knoxville, Tennessee, United States
Texas Oncology West, Amarillo, Texas, United States
Southwest Regional Cancer Center, Austin, Texas, United States
Texas Oncology-Denton South, Denton, Texas, United States
South Texas Cancer Center - McAllen, McAllen, Texas, United States
Texas Oncology- Northeast Texas, Tyler, Texas, United States
Community Cancer Trials of Utah, Ogden, Utah, United States
Oncology & Hematolgy Associates of SW Va Inc. - Roanoke, Roanoke, Virginia, United States
Canberra Hospital; Haematology Department, Canberra, Australian Capital Territory, Australia
Liverpool Hospital; Haematology, Liverpool, New South Wales, Australia
Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia
Royal North Shore Hospital; Haematology Department, St. Leonards, New South Wales, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
The Northern Hospital, Epping, Victoria, Australia
Peter MacCallum Cancer Centre; Department of Haematology, Melbourne, Victoria, Australia
Monash Medical Centre; Haematology, Melbourne, Victoria, Australia
CHU de Caen, Institut d'Hématologie de Basse-Normandie, Caen, , France
Hopital Henri Mondor; Hematologie Clinique, Creteil, , France
Clinique Victor Hugo- CCS du Mans, Le Mans, , France
CHRU Lille - Hôpital Claude Huriez; Service des Maladies du Sang, Lille, , France
Hopital Saint Jean : Pole Santé du Rousillon; Unité de Recherche clinique, Perpignan, , France
Hopital De Haut Leveque; Hematologie Clinique, Pessac, , France
Ch Lyon Sud; Hemato Secteur Jules Courmont, Pierre Benite, , France
Hopital De La Miletrie; Hematologie Et Oncologie Medicale, Poitiers, , France
Hopital Robert Debre; Hematologie Clinique, Reims, , France
CHI de Toulon - Hôpital Sainte Musse, Toulon, , France
Hopital Bretonneau; Hematologie Therapie Cellulaire, TOURS Cedex, , France
Azienda Ospedaliero-Universitaria Policlinico di Modena Ematologia, Modena, Emilia-Romagna, Italy
Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol, Roma, Lazio, Italy
Uni Cattolica; Divisione Di Ematologia, Roma, Lazio, Italy
A.O. Universitaria S. Martino Di Genova; Ematologia 1, Genova, Liguria, Italy
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora, Milano, Lombardia, Italy
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia, Milano, Lombardia, Italy
SCDU Ematologia, Novara, Piemonte, Italy
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica, Bari, Puglia, Italy
Asl Le-Ospedale "Vito Fazzi";U.O. Ematologia, Lecce, Puglia, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica, Sant'Andrea Delle Fratte (PG), Umbria, Italy
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia, Badalona, Barcelona, Spain
Hospital de Navarra, Servicio de Hematología, Pamplona, Navarra, Spain
Hospital Universitario de Canarias;servicio de Hematologia, La Laguna, Tenerife, Spain
Hospital Universitario la Paz; Servicio de Hematologia, Madrid, , Spain
Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología, Murcia, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Hematologia, Sevilla, , Spain
Hospital Universitario de Toledo, Toledo, , Spain
Contact Details
Name: Clinical trial
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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