A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

267

Participants

Timeline

Start Date

November 17, 2013

Primary Completion Date

June 28, 2017

Study Completion Date

June 28, 2019

Conditions
Lymphoma, Non-Hodgkin
Interventions
DRUG

Venetoclax

Venetoclax 200 to 800 milligrams (mg) tablets will be administered orally once daily (QD) on Days 4-10 of Cycle 1 and Days 1-10 of Cycles 2-8 during Phase I and MTD will be administered according to the same schedule during Phase II.

DRUG

Cyclophosphamide

Cyclophosphamide 750 milligrams per square meter (mg/m\^2) administered intravenously (IV) on Day 1 of each 21-day cycle up to Cycle 6.

DRUG

Obinutuzumab

Obinutuzumab will be administered by IV infusion as an absolute dose of 1000 mg on Days 1, 8, 15 of Cycle 1 and Day 1 of Cycles 2-8 (cycle length = 21 days).

DRUG

Rituximab

Rituximab 375 mg/m\^2 dose will be administered IV on Day 1 of every 21-day cycle.

DRUG

Doxorubicin

Doxorubicin 50 mg/m\^2 administered IV on Day 1 of each 21-day cycle up to Cycle 6.

DRUG

Vincristine

Vincristine 1.4 mg/m\^2 (maximum 2 mg) administered IV on Day 1 of each 21-day cycle up to Cycle 6.

DRUG

Prednisone

Prednisone 100 mg per day orally on Days 1-5 of each 21-day cycle up to Cycle 6.

Trial Locations (52)

1083

Semmelweis Egyetem, Budapest

1090

Medizinische Universität Wien, Vienna

1122

Orszagos Onkologiai Intezet, Budapest

2139

Concord Repatriation General Hospital, Concord

3000

Peter MacCallum Cancer Centre-East Melbourne, Melbourne

3050

Royal Melbourne Hospital, Parkville

4032

Debreceni Egyetem; Belgyogyaszati Klinika Hematologiai Tanszek, Debrecen

4102

Princess Alexandra Hospital, Woolloongabba

5020

LKH - Universitätsklinikum der PMU Salzburg, Salzburg

10065

Memorial Sloan-Kettering Cancer Center, New York

10126

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin

14642

Uni of Rochester Medical Center; Wilmot Cancer Center, Pharmacy Department, Rochester

16132

Azienda Ospedaliero Universitaria San Martino, Genoa

28034

Hospital Universitario Ramon y Cajal, Madrid

34295

Hopital Saint Eloi, Montpellier

35033

CHU Rennes - Hopital Pontchaillou, Rennes

37007

Hospital Universitario de Salamanca, Salamanca

37203

Tennessee Oncology, Nashville

44093

CHU Nantes - Hôtel Dieu; Service Assistance Medicale à la Procreation, Nantes

54511

Hôpital de Brabois Adultes, Vandœuvre-lès-Nancy

56100

Azienda Ospedaliero Universitaria Pisana; U.O. Farmaceutica, Pisa

59037

Hopital Claude Huriez - CHU Lille, Lille

63129

The West Clinici, St Louis

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

72015

Clinique Victor Hugo; Pharmacie, Le Mans

75475

Hôpital Saint-Louis, Paris

76038

Centre Henri Becquerel; Hematologie, Rouen

80131

Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale, Napoli

85025

Centre Hospitalier Départemental Les Oudairies, La Roche-sur-Yon

87401

San Juan Oncology Associates, Farmington

90095

UCLA Jonsson Comprehensive Cancer Center, Los Angeles

90127

Azienda Ospedaliera Vincenzo Cervello, Palermo

92835

St. Jude Heritage Healthcare, Fullerton

93454

Central Coast Medical Oncology, Santa Maria

94010

Hopital Henri Mondor, Unite Hemopathies lymphoides, Créteil

280146

Hospital Universitario La Paz, Madrid

07601

Hackensack University Medical Center; WFAN - Imus Pediatric Center, Hackensack

T6G 1Z2

Cross Cancer Institute, Edmonton

V1Y 5L3

BC Cancer Agency, CSI, Kelowna

V5Z 4E6

BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency, Vancouver

H3T 1E2

Jewish General Hospital; Research Unit, Montreal

G1J 1Z4

CHU de Quebec - Hôpital de l' Enfant Jésus, Québec

613 00

Fakultni nemocnice Brno, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

708 52

Fakultni nemocnice Ostrava, Ostrava - Poruba

128 08

Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK, Prague

1081 HV

Amsterdam UMC Location VUMC, Amsterdam

3015 GD

Erasmus Medisch Centrum, Rotterdam

3508 GA

UMC Utrecht, Utrecht

08003

Hospital del Mar, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08907

ICO l´Hospitalet - Hospital Duran i Reynals; Hematology, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY