A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

December 22, 2015

Primary Completion Date

April 11, 2018

Study Completion Date

May 8, 2020

Conditions
Diffuse Large B-Cell Lymphoma, Lymphoma Follicular
Interventions
DRUG

Atezolizumab

Atezo-G-Benda: Atezolizumab 840 milligrams (mg) intravenously (IV) on Days 1 and 15 of Cycles 2-6, during induction treatment, followed by 840 mg IV on Days 1 and 2 of each month, starting with Month 1, during maintenance treatment. Atezo-G-CHOP: Atezolizumab 1200 mg IV on Day 1 Cycles 2-6, during induction treatment, followed by 840 mg IV on Days 1 and 2 of each month, starting with Month 1. Atezo-R-CHOP: Atezolizumab 1200 mg IV on Day 1 Cycles 2-8, during induction treatment, followed by 1200 mg IV on Day 1 of Cycles 9-25.

DRUG

Bendamustine

Bendamustine will be administered at a dose of 90 milligrams per square meter (mg/m\^2) IV on Days 1 and 2 of Cycles 1-6, during induction treatment.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered at a dose of 750 mg/m\^2 IV on Day 1 of Cycle 1-6/8, during induction treatment.

DRUG

Doxorubicin

Doxorubicin will be administered at a dose of 50 mg/m\^2 IV on Day 1 of Cycle 1-6/8, during induction treatment.

DRUG

Obinutuzumab

Atezo-G-Benda: Obinutuzumab will be administered at a dose of 1000 mg IV on Days 1, 8, and 15 of Cycle 1 and 1000 mg IV on Day 1 of Cycles 2-6, during induction treatment, followed by 1000 mg IV on Day 1 of every other month, starting with Month 1, during maintenance treatment. Atezo-G-CHOP: Obinutuzumab will be administered at a dose of 1000 mg IV on Days 1, 8, and 15 of Cycle 1 and 1000 mg IV on Day 1 of Cycles 2-6 during induction treatment, followed by 1000 mg IV on Day 1 of every other month, starting with Month 1 during maintenance treatment.

DRUG

Prednisone

Prednisone will be administered at a dose of 40 mg/m\^2 orally on Days 1-5 of Cycle 1-6/8, during induction treatment. Prednisolone may be given if prednisone is unavailable. The 40 mg/m\^2 dose of prednisone on Day 1 will be replaced by oral corticosteroids given as premedication on Day 1 of Cycle 1 (and subsequent cycles).

DRUG

Vincristine

Vincristine will be administered at a dose of 1.4 mg/m\^2 (maximum 2 mg) IV on Day 1 of Cycle 1-6/8, during induction treatment.

DRUG

Rituximab

Atezo-R-CHOP: Participants with previously untreated DLBCL will receive rituximab at a dose of 375 mg/m\^2 IV on Day 1 of Cycle 1-8, during induction treatment.

Trial Locations (21)

2139

Concord Repatriation General Hospital; Haematology, Sydney

2298

Calvary Mater Newcastle, Waratah

3084

Austin Hospital, Heidelberg

3168

Monash Medical Centre, Clayton

5011

The Queen Elizabeth Hospital; Haematology/Oncology, Woodville South

10016

New York Uni Medical Center, New York

10065

Memorial Sloan-Kettering Cancer Center, New York

10126

AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette, Torino

15224

Western Pennsylvania Hospital, Pittsburgh

20007

Georgetown University Medical Center, Washington D.C.

24100

Asst Papa Giovanni XXIII, Bergamo

33136

University Miami, Miami

40138

Azienda Ospedaliera S. Orsola-Malpighi, Bologna

47014

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola

47900

Ospedale Infermi di Rimini, Rimini

48100

Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia, Ravenna

50141

Azienda Ospedaliera Univ, Florence

75063

Texas Oncology-Tyler, Irving

78705

Texas Oncology, Austin

80012

Rocky Mountain Cancer Center - Aurora, Aurora

97477

Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute, Springfield

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02596971 - A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) | Biotech Hunter | Biotech Hunter