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.

NCT ID: NCT04680052

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 654 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2028-08-09

Brief Summary

This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

Conditions

Follicular Lymphoma; Marginal Zone Lymphoma

Keywords

MOR00208; INCMOR00208; tafasitamab

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm A : tafasitamab + rituximab + lenalidomide

Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)

Group Type: EXPERIMENTAL

tafasitamab

Intervention Type: DRUG

tafasitamab will be administered IV for 12 cycles

rituximab

Intervention Type: DRUG

Rituximab will be administered IV on cycles 1 - 5

lenalidomide

Intervention Type: DRUG

Lenalidomide will be administered PO for 12 cycles

Arm B : placebo+rituximab+lenalidomide

Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)

Group Type: PLACEBO_COMPARATOR

rituximab

Intervention Type: DRUG

Rituximab will be administered IV on cycles 1 - 5

lenalidomide

Intervention Type: DRUG

Lenalidomide will be administered PO for 12 cycles

placebo

Intervention Type: DRUG

placebo will be administered IV for 12 cycles

Interventions

tafasitamab

tafasitamab will be administered IV for 12 cycles

Intervention Type: DRUG

rituximab

Rituximab will be administered IV on cycles 1 - 5

Intervention Type: DRUG

lenalidomide

Lenalidomide will be administered PO for 12 cycles

Intervention Type: DRUG

placebo

placebo will be administered IV for 12 cycles

Intervention Type: DRUG

Other Intervention Names

INCMOR00208; MOR00208

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
• Willingness to avoid pregnancy or fathering children
• In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin)
• Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy
• Documented relapsed, refractory, or PD after treatment with systemic therapy
• ECOG performance status of 0 to 2

Exclusion Criteria

• Women who are pregnant or breastfeeding.
• Any histology other than FL and MZL or clinical evidence of transformed lymphoma
• Prior non-hematologic malignancy
• Congestive heart failure
• HCV positivity, chronic HBV infection or history of HIV infection
• Active systemic infection
• CNS lymphoma involvement
• Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1
• Prior use of lenalidomide in combination with rituximab

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

John Muir Health Clinical Research Center

Concord, California, United States

Marin Cancer Care

Greenbrae, California, United States

The Oncology Institute of Hope and Innovation

Pasadena, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Middlesex Hospital Cancer Center

Middletown, Connecticut, United States

Smilow Cancer Hospital

New Haven, Connecticut, United States

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Brcr Medical Center, Inc

Plantation, Florida, United States

Asclepes Research Centers

Weeki Wachee, Florida, United States

Northwest Georgia Oncology Centers,P.C

Marietta, Georgia, United States

Straub Medical Center

Honolulu, Hawaii, United States

Des Moines Oncology Research Association

Des Moines, Iowa, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Tulane University

New Orleans, Louisiana, United States

University of Maryland-Greenebaum Cancer Center

Baltimore, Maryland, United States

Cancer Center For Blood Disorders

Bethesda, Maryland, United States

Barbara Ann Karmanos Cancer Hospital

Detroit, Michigan, United States

Metro-Minnesota Community Oncology Reserch Consortium (Mmcorc)

Saint Louis Park, Minnesota, United States

Hattiesburg Clinic Hematology

Hattiesburg, Mississippi, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Nyu Clinical Cancer Center

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Integris Cancer Institute

Oklahoma City, Oklahoma, United States

Charleston Hematology Oncology Associates

Charleston, South Carolina, United States

Prisma Health Upstate

Greenville, South Carolina, United States

Prairie Lakes Health Care System, Inc.

Watertown, South Dakota, United States

Texas Oncology-Baylor Charles A. Sammons

Dallas, Texas, United States

The Center For Cancer and Blood Disorders

Fort Worth, Texas, United States

Lyndon B Johnson General Hospital

Houston, Texas, United States

Md Anderson Cancer Center

Houston, Texas, United States

Renovatio Clinical

Spring, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Vista Oncology Inc Ps

Olympia, Washington, United States

Virginia Mason Medical Center

Seattle, Washington, United States

University of Washington-Seattle Cancer Care Alliance

Seattle, Washington, United States

Northwest Medical Specialties Pllc

Tacoma, Washington, United States

St George Hospital

Kogarah, New South Wales, Australia

Liverpool Hospital

Sydney, New South Wales, Australia

Wollongong Hospital - Illawarra Regional Hospital

Wollongong, New South Wales, Australia

Gold Coast Hospital

Southport, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Northern Hospital

Melbourne, Victoria, Australia

Western Health

St Albans, Victoria, Australia

Perth Blood Institute

West Perth, Western Australia, Australia

Eastern Health

Box Hill, , Australia

Royal Hobart Hospital

Hobart, , Australia

Landeskrankenhaus Universitatsklinikum Graz

Graz, , Austria

Innsbruck University Hospital

Innsbruck, , Austria

Kepler Universitat Klinikum

Linz, , Austria

*Krankenhaus*

Vienna, , Austria

Zna Stuivenberg

Antwerp, , Belgium

A.Z. St.-Jan-Dienst Hematologie

Bruges, , Belgium

Institut Jules Bordet

Brussels, , Belgium

Cliniques Universitaires Ucl Saint-Luc

Brussels, , Belgium

Universitair Ziekenhuis Antwerpen, Dienst Hematologie

Edegem, , Belgium

Ghent University Hospital

Ghent, , Belgium

Universitair Ziekenhuis (Uz) Leuven

Leuven, , Belgium

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, , Belgium

AZ Delta

Roeselare, , Belgium

Chu Ucl Namur University Hospital Mont-Godinne

Yvoir, , Belgium

Cross Cancer Institute

Edmonton, Alberta, Canada

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Queen Elizabeth Ii Health Sciences Centre

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

Hospital Maisonneuve Rosemont

Montreal, Quebec, Canada

McGill University Jewish General Hospital

Montreal, Quebec, Canada

Chu de Quebec - Universite Laval (Chul)

Québec, Quebec, Canada

University

Brno, , Czechia

University Hospital Hradec Kralove

Hradec Králové, , Czechia

University Hospital Ostrava

Ostrava, , Czechia

University Hospital Kralovkse Vinohrady

Prague, , Czechia

Vseobecna Fakultni Nemocnice

Prague, , Czechia

University Hospital Motol

Prague, , Czechia

Aalborg University Hospital

Aalborg, , Denmark

Aarhus University Hospital

Aarhus, , Denmark

Odense University Hospital

Odense, , Denmark

Sjaellands Universitetshospital Naestved

Roskilde, , Denmark

Kuopio University Hospital

Kuopio, , Finland

Oulu University Hospital

Oulu, , Finland

Tampere University Hospital

Tampere, , Finland

Turku University Hospital

Turku, , Finland

Chu Amiens Picardie - Hopital Sud

Amiens, , France

Chu Angers Hotel Dieu Nord

Angers, , France

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

Bordeaux, , France

Centre Hospitalier Universitaire Chu Dijon Bourgogne - Hopital Francois Mitterrand

Dijon, , France

Centre Hospitalier de Versailles - Hopital Andre Mignot

Le Chesnay, , France

CHU Nantes

Nantes, , France

Hospital Saint-Louis Service Oncologie Medicale

Paris, , France

A.P.H. Paris Hopital Cochin

Paris, , France

Hôpital Pitié Salpêtrière

Paris, , France

Centre Hospitalier de Pontoise

Pontoise, , France

Centre Hospitalier Annecy-Genevois

Pringy, , France

Chru Hopitaux de Tours Hospital Bretonneau

Tours, , France

Klinikum St. Marien Amberg

Amberg, , Germany

Klinik Fur Innere Medizin Hamatologie and Onkologie

Berlin, , Germany

Universitatsklinikum Essen

Essen, , Germany

University Clinic Giessen Und Marburg Ukgm

Giessen, , Germany

Universitaetsmedizin Greifswald

Greifswald, , Germany

Statistics and Data Corporation (Sdc)

Landshut, , Germany

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, , Germany

Medizinische Fakultaet Mannheim Der Universitaet Heidelberg

Mannheim, , Germany

Universitatsklinikum Munster

Münster, , Germany

Onkologische Schwerpunktpraxis

Oldenburg, , Germany

Universitarsfrauenklinik Ulm

Ulm, , Germany

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

251 Air Force General Hospital

Athens, , Greece

General Hospital of Athens Laiko

Athens, , Greece

University Hospital of West Attica - Attikon

Athens, , Greece

University General Hospital of Patras

Pátrai, , Greece

Semmelweis Egyetem

Budapest, , Hungary

National Institute of Oncology

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

Debrecen, , Hungary

Markhot Ferenc Korhaz

Eger, , Hungary

Petz Aladar County Teaching Hospital

Győr, , Hungary

Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz

Nyíregyháza, , Hungary

University of Szeged

Szeged, , Hungary

Beaumont Hospital

Dublin, , Ireland

University Hospital Galway

Galway, , Ireland

Ha Emek Medical Center

Afula, , Israel

Soroka

Bear Sheva, , Israel

Shamir Medical Center Formerly Assaf Harofeh Medical Center

BEER Yaaqov, , Israel

Wolfson

Holon, , Israel

Shaare Zedek Mc

Jerusalem, , Israel

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

Jerusalem, , Israel

Hadassah

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Rabin Medical Center - Beilinson Hospital

Petah Tikva, , Israel

Sheba Medical Center

Tel Litwinsky, , Israel

Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

Bari, , Italy

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Brescia, , Italy

Divisione Clinicizzata Di Ematologia

Brescia, , Italy

Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

Candiolo, , Italy

Divisione Clinicizzata Di Ematologia

Catania, , Italy

Presidio Ospedaliero Vito Fazzi

Lecce, , Italy

Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

Milan, , Italy

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Istituto Nazionale Tumori Irccs Fondazione Pascale

Naples, , Italy

Universita Di Napoli Federico Ii

Napoli, , Italy

Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara

Novara, , Italy

Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano

Orbassano, , Italy

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

Palermo, , Italy

Fondazione Irccs Policlinico San Matteo

Pavia, , Italy

Ausl Di Placenza Ospedale Guglielmo Da Saliceto

Piacenza, , Italy

Uo Ematologia Univ - Aoup Santa Chiara Pisa

Pisa, , Italy

Ospedale Santa Maria Delle Croci

Ravenna, , Italy

Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

Ausl Della Romagna

Rimini, , Italy

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

Roma, , Italy

Ospedale Sant. Eugenio

Rome, , Italy

Irccs Azienda Ospedaliera Universitaria San Martino

San Martino, , Italy

Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

Torino, , Italy

Asugi Ospedale Maggiore

Trieste, , Italy

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Chugoku Center Hospital

Fukuyama-shi, , Japan

Gifu Municipal Hospital

Gifu, , Japan

Kagoshima University Hospital

Kagoshima, , Japan

National Cancer Center Hospital East

Kashiwa-shi, , Japan

Hospital of the University of Occupation and Environmental Health

Kitakyushu-shi, , Japan

Kobe City Medical Center General Hospital

Kobe, , Japan

Japanese Red Cross Nagoya Daini Hospital

Nagoya, , Japan

Iuhw Narita Hospital

Narita, , Japan

Kindai University Hospital

Osakasayama-shi, , Japan

Saitama Medical University Hospital

Saitama, , Japan

Osaka University Hospital

Suita-shi, , Japan

Juntendo University Hospital

Tokyo, , Japan

Mie University Hospital

Tsu, , Japan

Yamagata University Hospital

Yamagata, , Japan

Amsterdam University Medical Centre

Amsterdam, , Netherlands

Hospital Rijnstate

Arnhem, , Netherlands

Medisch Spectrum Twente

Enschede, , Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

HMC

Leidschendam, , Netherlands

Innlandet Hospital Trust

Brumunddal, , Norway

Universitetssykehuset I Trondheim - St. Olavs Hospital

Trondheim, , Norway

Szpital Spec Brzozowiepoland

Brzozów, , Poland

Pratia Poznan

Katowice, , Poland

Pratia McM Krakow

Krakow, , Poland

Sp Zoz Szpital Uniwersytecki

Krakow, , Poland

Uniwersytet Medyczny W Lodzi - Klinika Hematologii

Lodz, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1

Lublin, , Poland

Specjalistyczny Szpital Onkologiczny

Tomaszów Mazowiecki, , Poland

Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, , Poland

Institute of Hematology and Transfusion Medicine

Warsaw, , Poland

Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego

Wroclaw, , Poland

Rostov State Medical University

Rostov-on-Don, , Russia

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, , Russia

Pusan National University Yangsan Hospital

Busan, , South Korea

Inje University Busan Paik Hospital

Busan, , South Korea

Dong-A University Hospital

Busan, , South Korea

Pusan National University Yangsan Hospital

Busan, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

Daegu Catholic University Medical Center

Daegu, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Chungnam National University

Daejeon, , South Korea

Gacheon University Gil Medical Center

Incheon, , South Korea

Jeonbuk National University Hospital

Jeonju, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

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

Seoul, , South Korea

Complejo Hospitalario Universitario A Coruna

A Coruña, , Spain

Hospital General Unviersitario de Alicante

Alicante, , Spain

Ico Hospital Germans Trias I Pujol

Badalona, , Spain

Hospital Del Mar

Barcelona, , Spain

Hospital General Universitario Vall D Hebron

Barcelona, , Spain

Hospital de La Santa Creu I Sant Pau

Barcelona, , Spain

Hospital Universitario de Burgos

Burgos, , Spain

Hospital Universitario de Cabuenes

Gijón, , Spain

Institut Catala Doncologia Ico - Hospital Duran I Reynals Location

L'Hospitalet de Llobregat, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Hospital Universitario Ramon Y Cajal

Madrid, , Spain

Fundacion Jimenez Diaz University Hospital

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario Quironsalud Madrid

Madrid, , Spain

Hospital Puerta de Hierro

Majadahonda, , Spain

Hospital Universitario Virgen de La Victoria

Málaga, , Spain

Hospital Universitario Virgen de La Arrixaca

Murcia, , Spain

Hospital Son Llatzer

Palma de Mallorca, , Spain

Consorci Hospitalari Parc Tauli de Sabadell

Sabadell, , Spain

Hospital Clinico Universitario de Salamanca

Salamanca, , Spain

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Hospital Universitario Virgen del Rocio Sevilla

Seville, , Spain

Hospital Universitari Mutua Terrassa

Terrassa, , Spain

Hospital Universitario Doctor Peset

Valencia, , Spain

Hospital Universitari I Politecnic La Fe

Valencia, , Spain

Hospital Universitario de Alava

Vitoria-Gasteiz, , Spain

Karolinska University Hospital Solna

Solna, , Sweden

Goetalandsregionen - Uddevalla Sjukhus Us

Uddevalla, , Sweden

Uppsala Universitet - Akademiska Sjukhuset

Uppsala, , Sweden

University Hospital of Basel Department of Oncology

Basel, , Switzerland

Oncological Institute of Southern Switzerland

Bellinzona, , Switzerland

Inselspital - Universitaetsspital Bern

Bern, , Switzerland

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Kantonsspital Winterthur

Winterthur, , Switzerland

Universitatsspital Zurich

Zurich, , Switzerland

E-Da Hospital

Kaohsiung City, , Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Far Eastern Memorial Hospital

New Taipei City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

National Cheng Kung University (Ncku) Hospital

Tainan, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Tri Service General Hospital

Taipei, , Taiwan

Institutional Review Board Taipei Veterans General Hospital

Taipei, , Taiwan

Hematology and Medical Oncology Too Foundation Sun Yat Sen Cancer Center

Taipei, , Taiwan

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, , Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, , Turkey (Türkiye)

Acibadem Maslak Hospital

Istanbul, , Turkey (Türkiye)

Communal Non-Profit Enterprise Regional Center of Oncology

Kharkiv, , Ukraine

National Cancer Institute of Ministry of Health

Kyiv, , Ukraine

University Hospitals Birmingham Nhs Foundation Trust

Birmingham, , United Kingdom

Bristol Haematology and Oncology Centre

Bristol, , United Kingdom

Leicester Royal Infirmary

Leicester, , United Kingdom

The Royal Marsden Nhs Foundation Trust - Chelsea

London, , United Kingdom

The Christie Nhs Foundation Trust Uk

Manchester, , United Kingdom

James Cook University Hospital

Middlesbrough, , United Kingdom

The Royal Marsden Nhs Foundation Trust - Sutton

Sutton, , United Kingdom

The Royal Wolverhampton Nhs Trust

Wolverhampton, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Canada; Czechia; Denmark; Finland; France; Germany; Greece; Hungary; Ireland; Israel; Italy; Japan; Netherlands; Norway; Poland; Russia; South Korea; Spain; Sweden; Switzerland; Taiwan; Turkey (Türkiye); Ukraine; United Kingdom

References

Sehn LH, Hubel K, Luminari S, Scholz CW, Salar A, Paneesha S, Wahlin BE, Panayiotidis P, Lee HP, Jimenez-Ubieto A, Sancho JM, Kim TM, Domingo Domenech E, Kumode T, Poh C, Thieblemont C, Deeren D, de Wit E, Arbushites M, Vassallo I, Trneny M; inMIND Study team. Tafasitamab, lenalidomide, and rituximab in relapsed or refractory follicular lymphoma (inMIND): a global, phase 3, randomised controlled trial. Lancet. 2025 Dec 5:S0140-6736(25)01778-7. doi: 10.1016/S0140-6736(25)01778-7. Online ahead of print.

Reference Type: DERIVED

PMID: 41360064 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://incyteclinicaltrials.com/studies/incmor-0208-301

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.

Other Identifiers

2023-504684-16-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-004407-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INCMOR 0208-301

Identifier Type: -

Identifier Source: org_study_id