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

PHASE3CompletedINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

May 28, 2020

Primary Completion Date

March 19, 2024

Study Completion Date

March 19, 2025

Conditions
Chronic Lymphocytic Leukemia (CLL)
Interventions
DRUG

Obinutuzumab

Obinutuzumab 1000 milligrams (mg) will be administered IV on Days 1 (and 2), 8, and 15 of Cycle 1 and on Day 1 of Cycles 2-6.

DRUG

Venetoclax

Venetoclax 20 mg will be administered orally, once daily starting on Day 22 of Cycle 1 for 7 days, then ramp up from 50 to 400 mg/day during Cycle 2 and continue at 400 mg/day from Day 1 of Cycle 3 till end of Cycle 12.

DRUG

Fludarabine

Fludarabine will be administered in a dosage of 25 milligram per meter squared (mg/m\^2), IV, on days 1, 2, and 3 of Cycles 1-6.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered in a dosage of 250 mg/m\^2, IV, on Days 1, 2, and 3 Cycles 1-6.

DRUG

Rituximab

Rituximab will be administered at a dose of 375 mg/m\^2, IV, on Cycle 1, Day 1 followed by 500 mg/m\^2 on Day 1 of Cycles 2-6.

DRUG

Bendamustine

Bendamustine will be administered at a dose of 90 mg/m\^2, IV, on 2 consecutive days of Cycles 1-6.

Trial Locations (40)

161

Policlinico Umberto I, Rome

168

Fondazione Policlinico Universitario Agostino Gemelli, Rome

2065

Royal North Shore Hospital, St Leonards

2170

Liverpool Hospital, Liverpool

2444

Port Macquarie - Mid North Coast Cancer Institute, Port Macquarie

2605

Canberra Hospital, Canberra

3050

Peter MacCallum Cancer Centre;Clinical Haematology, Melbourne

3076

Northern Hospital;Oncology and/or Hematology, Melbourne

3168

Monash Health;Haematology Research, Clayton

6132

AO Santa Maria della Misericordia, Perugia

7000

Royal Hobart Hospital, Hobart

8035

Hospital Universitari Vall d'Hebron;Hematology, Barcelona

8916

Hospital Germans Trias i Pujol, Badalona

14000

Centre Hospitalier Universitaire de Caen Normandie, Caen

16132

Ospedale San Martino;U.O. Clinica Ematologica, Genoa

20122

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico;U.O.C Ematologia, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda;Ematologia, Milan

20817

American Oncology Partners of Maryland, PA, Bethesda

24014

Oncology & Hematology Associates of Southwest Virginia, Inc._Goldschmidt, Roanoke

28015

Hospital Universitario La Paz;Hematología, Madrid

28100

Azienda Ospedaliero Universitaria Maggiore della Carità;SCDU Ematologia, Novara

30008

Hospital General Universitario Morales Meseguer;Hematologia y Oncologia médica, Murcia

31008

COMPLEJO HOSPITALARIO DE NAVARRA;Servicio de Hematología, Pamplona

33600

Hopital Haut Leveque Chu de Bordeaux, Pessac

37032

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau;Hématologie et Thérapie Cellulaire, Tours

37920

University of Tennessee Medical Center;Office of Clinical Trials, Knoxville

41009

Hospital Universitario Virgen del Rocío;Unidad Onco-Hematología Pediátrica, Seville

41125

Azienda Ospedaliero Universitaria;Ematologia, Modena

45007

Hospital Universitario de Toledo, Toledo

51092

Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré;Hématologie Clinique, Reims

59037

Hopital Claude Huriez - CHU de Lille;service maladies appareil digestif, Lille

66046

Centre Hospitalier de Pérpignan;hématologie, Perpignan

69310

centre hospitalier lyon sud;Service Hématologie, Pierre-Bénite

70124

Instituto Tumori Giovanni Paolo II;ONCOLOGIA MEDICA, Bari

72000

Clinique Victor Hugo- CCS du Mans, Le Mans

73100

Ospedale Vito Fazzi;U.O. Ematologia IV Piano Polo Oncologico, Lecce

80012

Medical Center of Aurora, Aurora

83100

Centre Hospitalier intercommunal de Toulon La Seyne sur Mer, Toulon

86021

Centre Hospitalier Universitaire de Poitiers, Poitiers

94000

HENRI MONDOR HOSPITAL;Centre d'investigation clinique, Créteil

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04285567 - 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 | Biotech Hunter | Biotech Hunter