A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

331

Participants

Timeline

Start Date

October 15, 2014

Primary Completion Date

October 21, 2021

Study Completion Date

October 21, 2021

Conditions
Lymphoma
Interventions
DRUG

Bendamustine

Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).

DRUG

Obinutuzumab

Obinutuzumab 1000 milligrams (mg) IV on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).

DRUG

Polatuzumab vedotin (Liquid)

Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).

DRUG

Rituximab

Rituximab standard dose, 375 mg/m\^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).

DRUG

Polatuzumab vedotin (Lyophilized)

Participants in the New Formulation (NF) Cohort (Arms G and H) will follow the same schedule and dosing requirements as participants in the other Phase II cohorts (Arms A-F).

Trial Locations (62)

1083

Semmelweis University, First Dept of Medicine, Budapest

1122

National Institute of Oncology, A Dept of Internal Medicine, Budapest

2031

Prince of Wales Hospital; Oncology, Randwick

3168

Monash Medical Centre; Haematology Research, Clayton

4032

University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B, Debrecen

5000

Royal Adelaide Hospital, Adelaide

5037

Adelaide Cancer Centre, Kurralta Park

10065

Memorial Sloan Kettering Cancer Center, New York

15121

Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia, Alessandria

20141

Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia, Milan

21079

Chu Site Du Bocage;Hematologie Clinique, Dijon

21237

Weinberg CA Inst Franklin Sq, Baltimore

25123

A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia, Brescia

28046

Hospital Universitario la Paz; Servicio de Hematologia, Madrid

28204

Levine Cancer Institute, Charlotte

30322

Emory Univ Winship Cancer Inst, Atlanta

32256

Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy), Jacksonville

32429

Joh. Wesling Klinikum Minden; Klinik fuer Hämatologie und Onkologie, Minden

34295

CHU Saint Eloi; Service d'Hématologie Clinique, Montpellier

35100

Dokuz Eylul Uni ; Hematology, Izmir

35805

Clearview Cancer Institute, Huntsville

37007

Hospital Clinico Universitario de Salamanca;Servicio de Hematologia, Salamanca

38138

West Clinic, Germantown

41013

Hospital Universitario Virgen del Rocio; Servicio de Hematologia, Seville

47905

Horizon Oncology Research, Inc., Lafayette

48153

Gemeinschaftspraxis für Hämatologie und Onkologie, Münster

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Abt. für Hämatologie und Onkologie, Mainz

55139

Ondokuzmayis University Medical Faculty Heamatology Department, Samsun

60435

Joliet Oncology-Hematology; Associates, Ltd., Joliet

61800

Karadeniz Technical Uni School of Medicine; Hematology, Trabzon

69310

CHU Lyon Sud - Service Hématologie, Pierre-Bénite

69373

Centre Leon Berard; Departement Oncologie Medicale, Lyon

70852

Fakultní nemocnice Ostrava Klinika hematoonkologie, Ostrava

76038

Centre Henri Becquerel; Hematologie, Rouen

80045

Univ of Colorado Canc Ctr, Aurora

80131

Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica, Napoli

85925

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

87131

University of New Mexico Cancer Center, Albuquerque

91010

City of Hope National Medical Center, Duarte

93053

Klinik der Uni Regensburg; Hämatologie/Onkologie, Studienzentrale, Regensburg

98104

Swedish Cancer Inst., Seattle

98405

Northwest Medical Specialties, Tacoma

99089

HELIOS Klinikum Erfurt - Innere Medizin - 4. Medizinische Klinik, Hämatologie, Erfurt

35294-3300

University of Alabama at Birmingham, Birmingham

07962

Regional Cancer Care Associates LLC - Morristown, Morristown

V5Z 4E6

BCCA-Vancouver Cancer Centre, Vancouver

B3H 2Y9

Queen Elizabeth II Health Sciences Centre; Oncology, Halifax

H1T 2M4

Hopital Maisonneuve- Rosemont; Oncology, Montreal

H3T 1E2

Jewish General Hospital, Montreal

625 00

Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

128 08

I Interni klinika; Vseobecna fakultni nemocnice, Prague

6525 GA

UMC St. Radboud; Hematology, Nijmegen

03080

Seoul National University Hospital, Seoul

06351

Samsung Medical Center, Seoul

08035

Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona

08036

Hospital Clinic i Provincial de Barcelona; Hematology, Barcelona

06620

Ankara University; Hematology, Ankara

SE1 9RT

KINGS COLLEGE HOSPITAL; Commercial R&D Amendments, Kings Health Partners Clinical Trials Office, London

M2O 4BX

Christie Hospital Nhs Trust; Medical Oncology, Manchester

NG5 1PB

Nottingham City Hospital; Dept of Haematology, Nottingham

SO16 6YD

Southampton General Hospital; Somers Cancer Research Building, Southampton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02257567 - A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma | Biotech Hunter | Biotech Hunter