A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pola), and Atezolizumab (Atezo) in Participants With Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab, Atezo, and Pola in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 9, 2016

Primary Completion Date

September 3, 2018

Study Completion Date

October 7, 2019

Conditions
Lymphoma
Interventions
DRUG

Atezolizumab [TECENTRIQ]

"Atezolizumab will be administered by intravenous (IV) infusion at a flat dose of 1200 milligram (mg) every 3 weeks (Q3W) on Day 1 of Cycles 2-6, given in 21-day cycles during induction treatment.~NOTE: Atezolizumab treatment has been discontinued in all participants currently on study treatment."

DRUG

Obinutuzumab

Obinutuzumab will be administered by IV infusion at a flat dose of 1000 mg on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6, given in 21-day cycles during induction treatment, and on Day 1 of every other month during maintenance treatment (1 cycle=21 days; infusion rate starts at 50 mg/hour (hr) and increases every 30 min to a maximum of 400 mg/hr).

DRUG

Polatuzumab Vedotin

Polatuzumab vedotin will be administered by IV infusion. For relapsed or refractory FL either 1.4 mg/kilogram (kg) or 1.8 mg/kg (dose-escalation phase) and at RP2D (dose-expansion phase) on Day 1 of Cycles 1-6 will be given in 21-day cycles during induction treatment. For relapsed or refactory DLBCL, 1.8 mg/kg will be given during run-in phase and either 1.8 mg/kg or 1.4 mg/kg during the expansion phase (1 cycle=21 days; infusion rate starts with 90 min and decreases to 30 min).

DRUG

Rituximab

Rituximab will be administered by IV infusion at 375 mg/m˄2 on Day 1 of Cycles 1-6 during induction treatment (1 cycle-21 days; infusion rate starts with 50 mg/hr and increases every 30 min to a maximum of 400 mg/hr).

Trial Locations (19)

9351

Wojewódzki Szpital Specjalistyczny im.MikołajaKopernika;KlinikaHematologiiUniwersytetuMedycznego, Lodz

11794

Stony Brook University Hospital, Stony Brook

17475

Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik, Greifswald

26506

Robert Byrd Health Science; Dept of Medicine, Section of Hematology/Oncology, Morgantown

30625

Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie, Hanover

33136

University Miami, Miami

45122

Uniklinik Essen, Essen

60590

Universitatsklinikum Frankfurt, Frankfurt

81675

Klinikum rechts der Isar der Technischen Universität München, München

90095

UCLA, Los Angeles

97080

Universitätsklinikum Würzburg, Würzburg

99336

Columbia Basin Hem-Onc; Department Hematology Oncology, Kennewick

06847

Städtisches Klinikum Dessau Klinik für Innere Medizin Abt. Intensivmedizin, Dessau

07747

Universitätsklinikum Jena Klinik f.Chirurgie Abt. Allgemein- und Viszeralchirurgie, Jena

81-519

Szpitale Wojewodzkie w Gdyni Sp. z o.o., Gdynia

02-106

MTZ Clinical Research Sp. z o.o., Warsaw

02-776

Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych, Warsaw

02-781

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego, Warsaw

50-367

Medical Uni of Wroclaw; Hematology, Wroclaw

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02729896 - A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pola), and Atezolizumab (Atezo) in Participants With Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab, Atezo, and Pola in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | Biotech Hunter | Biotech Hunter