A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

654

Participants

Timeline

Start Date

April 15, 2021

Primary Completion Date

February 23, 2024

Study Completion Date

August 9, 2028

Conditions
Follicular LymphomaMarginal Zone Lymphoma
Interventions
DRUG

tafasitamab

tafasitamab will be administered IV for 12 cycles

DRUG

rituximab

Rituximab will be administered IV on cycles 1 - 5

DRUG

lenalidomide

Lenalidomide will be administered PO for 12 cycles

DRUG

placebo

placebo will be administered IV for 12 cycles

Trial Locations (261)

2650

Universitair Ziekenhuis Antwerpen, Dienst Hematologie, Edegem

3128

Eastern Health, Box Hill

8000

A.Z. St.-Jan-Dienst Hematologie, Bruges

8800

AZ Delta, Roeselare

10016

Nyu Clinical Cancer Center, New York

10034

University Hospital Kralovkse Vinohrady, Prague

10043

Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano, Orbassano

10060

Fondazione Del Piemonte Per L Oncologia Ircc Candiolo, Candiolo

10126

Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza, Torino

10967

Klinik Fur Innere Medizin Hamatologie and Onkologie, Berlin

11217

Institutional Review Board Taipei Veterans General Hospital, Taipei

11251

Hematology and Medical Oncology Too Foundation Sun Yat Sen Cancer Center, Taipei

11525

251 Air Force General Hospital, Athens

11527

General Hospital of Athens Laiko, Athens

12462

University Hospital of West Attica - Attikon, Athens

14263

Roswell Park Cancer Institute, Buffalo

15000

University Hospital Motol, Prague

15006

Complejo Hospitalario Universitario A Coruna, A Coruña

16132

Irccs Azienda Ospedaliera Universitaria San Martino, San Martino

17164

Karolinska University Hospital Solna, Solna

17475

Universitaetsmedizin Greifswald, Greifswald

18105

Ha Emek Medical Center, Afula

20133

Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano, Milan

20162

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan

20520

Turku University Hospital, Turku

20817

Cancer Center For Blood Disorders, Bethesda

21000

Centre Hospitalier Universitaire Chu Dijon Bourgogne - Hopital Francois Mitterrand, Dijon

21201

University of Maryland-Greenebaum Cancer Center, Baltimore

21565

Gacheon University Gil Medical Center, Incheon

22908

University of Virginia Medical Center, Charlottesville

25123

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, Brescia

Divisione Clinicizzata Di Ematologia, Brescia

26121

Onkologische Schwerpunktpraxis, Oldenburg

26504

University General Hospital of Patras, Pátrai

27100

Fondazione Irccs Policlinico San Matteo, Pavia

28007

Hospital General Universitario Gregorio Maranon, Madrid

28034

Hospital Universitario Ramon Y Cajal, Madrid

28040

Fundacion Jimenez Diaz University Hospital, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28100

Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara, Novara

28204

Levine Cancer Institute, Charlotte

28222

Hospital Puerta de Hierro, Majadahonda

28223

Hospital Universitario Quironsalud Madrid, Madrid

29010

Hospital Universitario Virgen de La Victoria, Málaga

29100

Ausl Di Placenza Ospedale Guglielmo Da Saliceto, Piacenza

29414

Charleston Hematology Oncology Associates, Charleston

29615

Prisma Health Upstate, Greenville

30060

Northwest Georgia Oncology Centers,P.C, Marietta

30120

Hospital Universitario Virgen de La Arrixaca, Murcia

32256

Cancer Specialists of North Florida, Jacksonville

33000

Groupe Bordeaux Nord Aquitaine Gbna Polycliniques - Polyclinique Bordeaux Nord Aquitaine Pbna, Bordeaux

33322

Brcr Medical Center, Inc, Plantation

33394

Hospital Universitario de Cabuenes, Gijón

33520

Tampere University Hospital, Tampere

34125

Asugi Ospedale Maggiore, Trieste

34457

Acibadem Maslak Hospital, Istanbul

34607

Asclepes Research Centers, Weeki Wachee

35015

Chungnam National University, Daejeon

35392

University Clinic Giessen Und Marburg Ukgm, Giessen

37007

Hospital Clinico Universitario de Salamanca, Salamanca

37044

Chru Hopitaux de Tours Hospital Bretonneau, Tours

39008

Hospital Universitario Marques de Valdecilla, Santander

39401

Hattiesburg Clinic Hematology, Hattiesburg

40207

Norton Cancer Institute, Louisville

40447

China Medical University Hospital, Taichung

40503

Baptist Health Lexington, Lexington

41005

Hospital Universitario Virgen del Rocio Sevilla, Seville

41944

Kyungpook National University Hospital, Daegu

42100

Arcispedale Santa Maria Nuova, Reggio Emilia

42472

Daegu Catholic University Medical Center, Daegu

42601

Keimyung University Dongsan Medical Center, Daegu

44093

CHU Nantes, Nantes

44281

Meir Medical Center, Kfar Saba

45147

Universitatsklinikum Essen, Essen

46017

Hospital Universitario Doctor Peset, Valencia

46026

Hospital Universitari I Politecnic La Fe, Valencia

47392

Inje University Busan Paik Hospital, Busan

47923

Ausl Della Romagna, Rimini

48121

Ospedale Santa Maria Delle Croci, Ravenna

48149

Universitatsklinikum Munster, Münster

48201

Barbara Ann Karmanos Cancer Hospital, Detroit

49100

Rabin Medical Center - Beilinson Hospital, Petah Tikva

49201

Dong-A University Hospital, Busan

49933

Chu Angers Hotel Dieu Nord, Angers

50309

Des Moines Oncology Research Association, Des Moines

50333

University Hospital Hradec Kralove, Hradec Králové

54907

Jeonbuk National University Hospital, Jeonju

55131

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii, Mainz

55416

Metro-Minnesota Community Oncology Reserch Consortium (Mmcorc), Saint Louis Park

56126

Uo Ematologia Univ - Aoup Santa Chiara Pisa, Pisa

57201

Prairie Lakes Health Care System, Inc., Watertown

61070

Communal Non-Profit Enterprise Regional Center of Oncology, Kharkiv

62500

University, Brno

68167

Medizinische Fakultaet Mannheim Der Universitaet Heidelberg, Mannheim

70112

Tulane University, New Orleans

70124

Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari, Bari

70210

Kuopio University Hospital, Kuopio

70300

Shamir Medical Center Formerly Assaf Harofeh Medical Center, BEER Yaaqov

70800

University Hospital Ostrava, Ostrava

73100

Presidio Ospedaliero Vito Fazzi, Lecce

73142

Integris Cancer Institute, Oklahoma City

74374

Centre Hospitalier Annecy-Genevois, Pringy

75010

Hospital Saint-Louis Service Oncologie Medicale, Paris

75014

A.P.H. Paris Hopital Cochin, Paris

75185

Uppsala Universitet - Akademiska Sjukhuset, Uppsala

75246

Texas Oncology-Baylor Charles A. Sammons, Dallas

75651

Hôpital Pitié Salpêtrière, Paris

76104

The Center For Cancer and Blood Disorders, Fort Worth

77026

Lyndon B Johnson General Hospital, Houston

77030

Md Anderson Cancer Center, Houston

77380

Renovatio Clinical, Spring

78150

Centre Hospitalier de Versailles - Hopital Andre Mignot, Le Chesnay

80054

Chu Amiens Picardie - Hopital Sud, Amiens

80131

Istituto Nazionale Tumori Irccs Fondazione Pascale, Naples

Universita Di Napoli Federico Ii, Napoli

84036

Statistics and Data Corporation (Sdc), Landshut

84107

Utah Cancer Specialists, Salt Lake City

89081

Universitarsfrauenklinik Ulm, Ulm

90146

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello, Palermo

90220

Oulu University Hospital, Oulu

91105

The Oncology Institute of Hope and Innovation, Pasadena

91120

"Laiko General Hospital of Athens, Hematology of the First Propaedeutic Internal Medicine Clinic", Jerusalem

Hadassah, Jerusalem

92123

Sharp Memorial Hospital, San Diego

92224

Klinikum St. Marien Amberg, Amberg

94904

Marin Cancer Care, Greenbrae

95123

Divisione Clinicizzata Di Ematologia, Catania

95303

Centre Hospitalier de Pontoise, Pontoise

96813

Straub Medical Center, Honolulu

97080

Universitaetsklinikum Wuerzburg, Würzburg

98101

Virginia Mason Medical Center, Seattle

98405

Northwest Medical Specialties Pllc, Tacoma

98506

Vista Oncology Inc Ps, Olympia

196022

Pavlov First Saint Petersburg State Medical University, Saint Petersburg

344022

Rostov State Medical University, Rostov-on-Don

5265601

Sheba Medical Center, Tel Litwinsky

5822012

Wolfson, Holon

9103102

Shaare Zedek Mc, Jerusalem

94520-2266

John Muir Health Clinical Research Center, Concord

06457

Middlesex Hospital Cancer Center, Middletown

06510

Smilow Cancer Hospital, New Haven

98109-4405

University of Washington-Seattle Cancer Care Alliance, Seattle

02217

St George Hospital, Kogarah

02170

Liverpool Hospital, Sydney

02500

Wollongong Hospital - Illawarra Regional Hospital, Wollongong

04215

Gold Coast Hospital, Southport

05000

Royal Adelaide Hospital, Adelaide

Odense University Hospital, Odense

05042

Flinders Medical Centre, Bedford Park

03004

The Alfred Hospital, Melbourne

03076

Northern Hospital, Melbourne

03021

Western Health, St Albans

06005

Perth Blood Institute, West Perth

07000

Royal Hobart Hospital, Hobart

08036

Landeskrankenhaus Universitatsklinikum Graz, Graz

06020

Innsbruck University Hospital, Innsbruck

04020

Kepler Universitat Klinikum, Linz

01090

*Krankenhaus*, Vienna

02060

Zna Stuivenberg, Antwerp

01000

Institut Jules Bordet, Brussels

01200

Cliniques Universitaires Ucl Saint-Luc, Brussels

09000

Ghent University Hospital, Ghent

Aalborg University Hospital, Aalborg

03000

Universitair Ziekenhuis (Uz) Leuven, Leuven

04000

Centre Hospitalier Universitaire de Liege - Sart Tilman, Liège

Sjaellands Universitetshospital Naestved, Roskilde

05530

Chu Ucl Namur University Hospital Mont-Godinne, Yvoir

T6G 1Z2

Cross Cancer Institute, Edmonton

V5Z 1L3

British Columbia Cancer Agency, Vancouver

B3H 2Y9

Queen Elizabeth Ii Health Sciences Centre, Halifax

N6A 5W9

London Health Sciences Centre, London

H1T 2M4

Hospital Maisonneuve Rosemont, Montreal

H3T 1E2

McGill University Jewish General Hospital, Montreal

G1J 1Z4

Chu de Quebec - Universite Laval (Chul), Québec

128 08

Vseobecna Fakultni Nemocnice, Prague

08200

Aarhus University Hospital, Aarhus

01088

Semmelweis Egyetem, Budapest

01122

National Institute of Oncology, Budapest

04032

Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika, Debrecen

03300

Markhot Ferenc Korhaz, Eger

09024

Petz Aladar County Teaching Hospital, Győr

04400

Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Nyíregyháza

06725

University of Szeged, Szeged

D9 V2N0

Beaumont Hospital, Dublin

H91 YR71

University Hospital Galway, Galway

Unknown

Soroka, Bear Sheva

00161

Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia, Roma

00144

Ospedale Sant. Eugenio, Rome

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

720-0001

Chugoku Center Hospital, Fukuyama-shi

500-8513

Gifu Municipal Hospital, Gifu

890-8520

Kagoshima University Hospital, Kagoshima

277-8577

National Cancer Center Hospital East, Kashiwa-shi

807-8556

Hospital of the University of Occupation and Environmental Health, Kitakyushu-shi

650-0047

Kobe City Medical Center General Hospital, Kobe

466 8650

Japanese Red Cross Nagoya Daini Hospital, Nagoya

286-8520

Iuhw Narita Hospital, Narita

589-8511

Kindai University Hospital, Osakasayama-shi

350-0495

Saitama Medical University Hospital, Saitama

565-0871

Osaka University Hospital, Suita-shi

113-8431

Juntendo University Hospital, Tokyo

514-8507

Mie University Hospital, Tsu

990-9585

Yamagata University Hospital, Yamagata

1105 AZ

Amsterdam University Medical Centre, Amsterdam

6815 AD

Hospital Rijnstate, Arnhem

7512 KZ

Medisch Spectrum Twente, Enschede

8934 AD

Medisch Centrum Leeuwarden, Leeuwarden

2622BA

HMC, Leidschendam

02381

Innlandet Hospital Trust, Brumunddal

07006

Universitetssykehuset I Trondheim - St. Olavs Hospital, Trondheim

36-200

Szpital Spec Brzozowiepoland, Brzozów

40-519

Pratia Poznan, Katowice

30-225

Pratia McM Krakow, Krakow

31-501

Sp Zoz Szpital Uniwersytecki, Krakow

93-510

Uniwersytet Medyczny W Lodzi - Klinika Hematologii, Lodz

20-081

Samodzielny Publiczny Szpital Kliniczny Nr 1, Lublin

97-200

Specjalistyczny Szpital Onkologiczny, Tomaszów Mazowiecki

02-0781

Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw

02-776

Institute of Hematology and Transfusion Medicine, Warsaw

50-367

Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego, Wroclaw

03181

Pusan National University Yangsan Hospital, Busan

602-739

Pusan National University Yangsan Hospital, Busan

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

07345

The Catholic University of Korea Yeoido St.Mary'S Hospital, Seoul

03010

Hospital General Unviersitario de Alicante, Alicante

Inselspital - Universitaetsspital Bern, Bern

08916

Ico Hospital Germans Trias I Pujol, Badalona

08003

Hospital Del Mar, Barcelona

08007

Hospital General Universitario Vall D Hebron, Barcelona

08041

Hospital de La Santa Creu I Sant Pau, Barcelona

09006

Hospital Universitario de Burgos, Burgos

08908

Institut Catala Doncologia Ico - Hospital Duran I Reynals Location, L'Hospitalet de Llobregat

07198

Hospital Son Llatzer, Palma de Mallorca

08208

Consorci Hospitalari Parc Tauli de Sabadell, Sabadell

08221

Hospital Universitari Mutua Terrassa, Terrassa

01009

Hospital Universitario de Alava, Vitoria-Gasteiz

451 53

Goetalandsregionen - Uddevalla Sjukhus Us, Uddevalla

04031

University Hospital of Basel Department of Oncology, Basel

06500

Oncological Institute of Southern Switzerland, Bellinzona

09007

Kantonsspital St. Gallen, Sankt Gallen

08401

Kantonsspital Winterthur, Winterthur

08091

Universitatsspital Zurich, Zurich

00824

E-Da Hospital, Kaohsiung City

00833

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

00220

Far Eastern Memorial Hospital, New Taipei City

00704

National Cheng Kung University (Ncku) Hospital, Tainan City

00100

National Taiwan University Hospital, Taipei

00114

Tri Service General Hospital, Taipei

06100

Hacettepe Universitesi Tip Fakultesi Hastanesi, Ankara

06590

Ankara University Medical Faculty, Ankara

03022

National Cancer Institute of Ministry of Health, Kyiv

B15 2GW

University Hospitals Birmingham Nhs Foundation Trust, Birmingham

BS2 8ED

Bristol Haematology and Oncology Centre, Bristol

LE1 5WW

Leicester Royal Infirmary, Leicester

SW3 6JJ

The Royal Marsden Nhs Foundation Trust - Chelsea, London

M20 4BX

The Christie Nhs Foundation Trust Uk, Manchester

TS4 3BW

James Cook University Hospital, Middlesbrough

SM2 5PT

The Royal Marsden Nhs Foundation Trust - Sutton, Sutton

WV10 0QP

The Royal Wolverhampton Nhs Trust, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY