NCT04680052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
654

participants targeted

Target at P75+ for phase_3

Timeline
27mo left

Started Apr 2021

Longer than P75 for phase_3

Geographic Reach
27 countries

257 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Apr 2021Aug 2028

First Submitted

Initial submission to the registry

December 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 4, 2025

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2028

Expected
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

2.9 years

First QC Date

December 17, 2020

Results QC Date

February 18, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

MOR00208INCMOR00208tafasitamab

Outcome Measures

Primary Outcomes (2)

  • FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First

    PD, positron emission tomography (PET): score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, computed tomography (CT): abnormal individual node/lesion with longest diameter (LDi ) \>1.5 centimeters (cm) and increase by ≥50% from the product of the perpendicular diameters (PPD) nadir and increase in LDi or shortest diameter (SDi) from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.

    up to approximately 34 months

  • FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First

    PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.

    up to 2 years

Secondary Outcomes (34)

  • Overall Population: PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First

    up to approximately 34 months

  • Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First

    up to 2 years

  • FDG-avid FL Population: Positron Emission Tomography-Complete Response (PET-CR) Rate by Investigator Assessment, Using the Lugano 2014 Criteria

    up to approximately 34 months

  • FL Population: Overall Survival

    up to approximately 34 months

  • FL Population: Kaplan-Meier Estimates of Overall Survival

    up to 2 years

  • +29 more secondary outcomes

Study Arms (2)

Arm A : tafasitamab + rituximab + lenalidomide

EXPERIMENTAL

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

Drug: tafasitamabDrug: rituximabDrug: lenalidomide

Arm B : placebo+rituximab+lenalidomide

PLACEBO COMPARATOR

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

Drug: rituximabDrug: lenalidomideDrug: placebo

Interventions

Rituximab will be administered IV on cycles 1 - 5

Arm A : tafasitamab + rituximab + lenalidomideArm B : placebo+rituximab+lenalidomide

Lenalidomide will be administered PO for 12 cycles

Arm A : tafasitamab + rituximab + lenalidomideArm B : placebo+rituximab+lenalidomide

placebo will be administered IV for 12 cycles

Arm B : placebo+rituximab+lenalidomide

tafasitamab will be administered IV for 12 cycles

Also known as: INCMOR00208, MOR00208
Arm A : tafasitamab + rituximab + lenalidomide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (261)

John Muir Health Clinical Research Center

Concord, California, 94520-2266, United States

Location

Marin Cancer Care

Greenbrae, California, 94904, United States

Location

The Oncology Institute of Hope and Innovation

Pasadena, California, 91105, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Middlesex Hospital Cancer Center

Middletown, Connecticut, 06457, United States

Location

Smilow Cancer Hospital

New Haven, Connecticut, 06510, United States

Location

Cancer Specialists of North Florida

Jacksonville, Florida, 32256, United States

Location

Brcr Medical Center, Inc

Plantation, Florida, 33322, United States

Location

Asclepes Research Centers

Weeki Wachee, Florida, 34607, United States

Location

Northwest Georgia Oncology Centers,P.C

Marietta, Georgia, 30060, United States

Location

Straub Medical Center

Honolulu, Hawaii, 96813, United States

Location

Des Moines Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

University of Maryland-Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Cancer Center For Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Barbara Ann Karmanos Cancer Hospital

Detroit, Michigan, 48201, United States

Location

Metro-Minnesota Community Oncology Reserch Consortium (Mmcorc)

Saint Louis Park, Minnesota, 55416, United States

Location

Hattiesburg Clinic Hematology

Hattiesburg, Mississippi, 39401, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Nyu Clinical Cancer Center

New York, New York, 10016, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Integris Cancer Institute

Oklahoma City, Oklahoma, 73142, United States

Location

Charleston Hematology Oncology Associates

Charleston, South Carolina, 29414, United States

Location

Prisma Health Upstate

Greenville, South Carolina, 29615, United States

Location

Prairie Lakes Health Care System, Inc.

Watertown, South Dakota, 57201, United States

Location

Texas Oncology-Baylor Charles A. Sammons

Dallas, Texas, 75246, United States

Location

The Center For Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Lyndon B Johnson General Hospital

Houston, Texas, 77026, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Renovatio Clinical

Spring, Texas, 77380, United States

Location

Utah Cancer Specialists

Salt Lake City, Utah, 84107, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Vista Oncology Inc Ps

Olympia, Washington, 98506, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

University of Washington-Seattle Cancer Care Alliance

Seattle, Washington, 98109-4405, United States

Location

Northwest Medical Specialties Pllc

Tacoma, Washington, 98405, United States

Location

St George Hospital

Kogarah, New South Wales, 02217, Australia

Location

Liverpool Hospital

Sydney, New South Wales, 02170, Australia

Location

Wollongong Hospital - Illawarra Regional Hospital

Wollongong, New South Wales, 02500, Australia

Location

Gold Coast Hospital

Southport, Queensland, 04215, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 05000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 05042, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 03004, Australia

Location

Northern Hospital

Melbourne, Victoria, 03076, Australia

Location

Western Health

St Albans, Victoria, 03021, Australia

Location

Perth Blood Institute

West Perth, Western Australia, 06005, Australia

Location

Eastern Health

Box Hill, 3128, Australia

Location

Royal Hobart Hospital

Hobart, 07000, Australia

Location

Landeskrankenhaus Universitatsklinikum Graz

Graz, 08036, Austria

Location

Innsbruck University Hospital

Innsbruck, 06020, Austria

Location

Kepler Universitat Klinikum

Linz, 04020, Austria

Location

*Krankenhaus*

Vienna, 01090, Austria

Location

Zna Stuivenberg

Antwerp, 02060, Belgium

Location

A.Z. St.-Jan-Dienst Hematologie

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels, 01000, Belgium

Location

Cliniques Universitaires Ucl Saint-Luc

Brussels, 01200, Belgium

Location

Universitair Ziekenhuis Antwerpen, Dienst Hematologie

Edegem, 2650, Belgium

Location

Ghent University Hospital

Ghent, 09000, Belgium

Location

Universitair Ziekenhuis (Uz) Leuven

Leuven, 03000, Belgium

Location

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, 04000, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

Chu Ucl Namur University Hospital Mont-Godinne

Yvoir, 05530, Belgium

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 1L3, Canada

Location

Queen Elizabeth Ii Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Hospital Maisonneuve Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

McGill University Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Chu de Quebec - Universite Laval (Chul)

Québec, Quebec, G1J 1Z4, Canada

Location

University

Brno, 62500, Czechia

Location

University Hospital Hradec Kralove

Hradec Králové, 50333, Czechia

Location

University Hospital Ostrava

Ostrava, 70800, Czechia

Location

University Hospital Kralovkse Vinohrady

Prague, 10034, Czechia

Location

Vseobecna Fakultni Nemocnice

Prague, 128 08, Czechia

Location

University Hospital Motol

Prague, 15000, Czechia

Location

Aalborg University Hospital

Aalborg, 09000, Denmark

Location

Aarhus University Hospital

Aarhus, 08200, Denmark

Location

Odense University Hospital

Odense, 05000, Denmark

Location

Sjaellands Universitetshospital Naestved

Roskilde, 04000, Denmark

Location

Kuopio University Hospital

Kuopio, 70210, Finland

Location

Oulu University Hospital

Oulu, 90220, Finland

Location

Tampere University Hospital

Tampere, 33520, Finland

Location

Turku University Hospital

Turku, 20520, Finland

Location

Chu Amiens Picardie - Hopital Sud

Amiens, 80054, France

Location

Chu Angers Hotel Dieu Nord

Angers, 49933, France

Location

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

Bordeaux, 33000, France

Location

Centre Hospitalier Universitaire Chu Dijon Bourgogne - Hopital Francois Mitterrand

Dijon, 21000, France

Location

Centre Hospitalier de Versailles - Hopital Andre Mignot

Le Chesnay, 78150, France

Location

CHU Nantes

Nantes, 44093, France

Location

Hospital Saint-Louis Service Oncologie Medicale

Paris, 75010, France

Location

A.P.H. Paris Hopital Cochin

Paris, 75014, France

Location

Hôpital Pitié Salpêtrière

Paris, 75651, France

Location

Centre Hospitalier de Pontoise

Pontoise, 95303, France

Location

Centre Hospitalier Annecy-Genevois

Pringy, 74374, France

Location

Chru Hopitaux de Tours Hospital Bretonneau

Tours, 37044, France

Location

Klinikum St. Marien Amberg

Amberg, 92224, Germany

Location

Klinik Fur Innere Medizin Hamatologie and Onkologie

Berlin, 10967, Germany

Location

Universitatsklinikum Essen

Essen, 45147, Germany

Location

University Clinic Giessen Und Marburg Ukgm

Giessen, 35392, Germany

Location

Universitaetsmedizin Greifswald

Greifswald, 17475, Germany

Location

Statistics and Data Corporation (Sdc)

Landshut, 84036, Germany

Location

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, 55131, Germany

Location

Medizinische Fakultaet Mannheim Der Universitaet Heidelberg

Mannheim, 68167, Germany

Location

Universitatsklinikum Munster

Münster, 48149, Germany

Location

Onkologische Schwerpunktpraxis

Oldenburg, 26121, Germany

Location

Universitarsfrauenklinik Ulm

Ulm, 89081, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, 97080, Germany

Location

251 Air Force General Hospital

Athens, 11525, Greece

Location

General Hospital of Athens Laiko

Athens, 11527, Greece

Location

University Hospital of West Attica - Attikon

Athens, 12462, Greece

Location

University General Hospital of Patras

Pátrai, 26504, Greece

Location

Semmelweis Egyetem

Budapest, 01088, Hungary

Location

National Institute of Oncology

Budapest, 01122, Hungary

Location

Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

Debrecen, 04032, Hungary

Location

Markhot Ferenc Korhaz

Eger, 03300, Hungary

Location

Petz Aladar County Teaching Hospital

Győr, 09024, Hungary

Location

Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz

Nyíregyháza, 04400, Hungary

Location

University of Szeged

Szeged, 06725, Hungary

Location

Beaumont Hospital

Dublin, D9 V2N0, Ireland

Location

University Hospital Galway

Galway, H91 YR71, Ireland

Location

Ha Emek Medical Center

Afula, 18105, Israel

Location

Soroka

Bear Sheva, Israel

Location

Shamir Medical Center Formerly Assaf Harofeh Medical Center

BEER Yaaqov, 70300, Israel

Location

Wolfson

Holon, 5822012, Israel

Location

Shaare Zedek Mc

Jerusalem, 9103102, Israel

Location

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

Jerusalem, 91120, Israel

Location

Hadassah

Jerusalem, 91120, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Rabin Medical Center - Beilinson Hospital

Petah Tikva, 49100, Israel

Location

Sheba Medical Center

Tel Litwinsky, 5265601, Israel

Location

Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

Bari, 70124, Italy

Location

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Brescia, 25123, Italy

Location

Divisione Clinicizzata Di Ematologia

Brescia, 25123, Italy

Location

Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

Candiolo, 10060, Italy

Location

Divisione Clinicizzata Di Ematologia

Catania, 95123, Italy

Location

Presidio Ospedaliero Vito Fazzi

Lecce, 73100, Italy

Location

Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

Milan, 20133, Italy

Location

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

Istituto Nazionale Tumori Irccs Fondazione Pascale

Naples, 80131, Italy

Location

Universita Di Napoli Federico Ii

Naples, 80131, Italy

Location

Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara

Novara, 28100, Italy

Location

Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano

Orbassano, 10043, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

Palermo, 90146, Italy

Location

Fondazione Irccs Policlinico San Matteo

Pavia, 27100, Italy

Location

Ausl Di Placenza Ospedale Guglielmo Da Saliceto

Piacenza, 29100, Italy

Location

Uo Ematologia Univ - Aoup Santa Chiara Pisa

Pisa, 56126, Italy

Location

Ospedale Santa Maria Delle Croci

Ravenna, 48121, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, 42100, Italy

Location

Ausl Della Romagna

Rimini, 47923, Italy

Location

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

Roma, 00161, Italy

Location

Ospedale Sant. Eugenio

Rome, 00144, Italy

Location

Irccs Azienda Ospedaliera Universitaria San Martino

San Martino, 16132, Italy

Location

Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

Torino, 10126, Italy

Location

Asugi Ospedale Maggiore

Trieste, 34125, Italy

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Chugoku Center Hospital

Fukuyama-shi, 720-0001, Japan

Location

Gifu Municipal Hospital

Gifu, 500-8513, Japan

Location

Kagoshima University Hospital

Kagoshima, 890-8520, Japan

Location

National Cancer Center Hospital East

Kashiwa-shi, 277-8577, Japan

Location

Hospital of the University of Occupation and Environmental Health

Kitakyushu-shi, 807-8556, Japan

Location

Kobe City Medical Center General Hospital

Kobe, 650-0047, Japan

Location

Japanese Red Cross Nagoya Daini Hospital

Nagoya, 466 8650, Japan

Location

Iuhw Narita Hospital

Narita, 286-8520, Japan

Location

Kindai University Hospital

Osakasayama-shi, 589-8511, Japan

Location

Saitama Medical University Hospital

Saitama, 350-0495, Japan

Location

Osaka University Hospital

Suita-shi, 565-0871, Japan

Location

Juntendo University Hospital

Tokyo, 113-8431, Japan

Location

Mie University Hospital

Tsu, 514-8507, Japan

Location

Yamagata University Hospital

Yamagata, 990-9585, Japan

Location

Amsterdam University Medical Centre

Amsterdam, 1105 AZ, Netherlands

Location

Hospital Rijnstate

Arnhem, 6815 AD, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7512 KZ, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, 8934 AD, Netherlands

Location

HMC

Leidschendam, 2622BA, Netherlands

Location

Innlandet Hospital Trust

Brumunddal, 02381, Norway

Location

Universitetssykehuset I Trondheim - St. Olavs Hospital

Trondheim, 07006, Norway

Location

Szpital Spec Brzozowiepoland

Brzozów, 36-200, Poland

Location

Pratia Poznan

Katowice, 40-519, Poland

Location

Pratia McM Krakow

Krakow, 30-225, Poland

Location

Sp Zoz Szpital Uniwersytecki

Krakow, 31-501, Poland

Location

Uniwersytet Medyczny W Lodzi - Klinika Hematologii

Lodz, 93-510, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1

Lublin, 20-081, Poland

Location

Specjalistyczny Szpital Onkologiczny

Tomaszów Mazowiecki, 97-200, Poland

Location

Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, 02-0781, Poland

Location

Institute of Hematology and Transfusion Medicine

Warsaw, 02-776, Poland

Location

Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego

Wroclaw, 50-367, Poland

Location

Rostov State Medical University

Rostov-on-Don, 344022, Russia

Location

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, 196022, Russia

Location

Pusan National University Yangsan Hospital

Busan, 03181, South Korea

Location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Pusan National University Yangsan Hospital

Busan, 602-739, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 42601, South Korea

Location

Chungnam National University

Daejeon, 35015, South Korea

Location

Gacheon University Gil Medical Center

Incheon, 21565, South Korea

Location

Jeonbuk National University Hospital

Jeonju, 54907, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

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

Seoul, 07345, South Korea

Location

Complejo Hospitalario Universitario A Coruna

A Coruña, 15006, Spain

Location

Hospital General Unviersitario de Alicante

Alicante, 03010, Spain

Location

Ico Hospital Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital General Universitario Vall D Hebron

Barcelona, 08007, Spain

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Hospital Universitario de Cabuenes

Gijón, 33394, Spain

Location

Institut Catala Doncologia Ico - Hospital Duran I Reynals Location

L'Hospitalet de Llobregat, 08908, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Location

Fundacion Jimenez Diaz University Hospital

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Quironsalud Madrid

Madrid, 28223, Spain

Location

Hospital Puerta de Hierro

Majadahonda, 28222, Spain

Location

Hospital Universitario Virgen de La Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Virgen de La Arrixaca

Murcia, 30120, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, 07198, Spain

Location

Consorci Hospitalari Parc Tauli de Sabadell

Sabadell, 08208, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Universitario Virgen del Rocio Sevilla

Seville, 41005, Spain

Location

Hospital Universitari Mutua Terrassa

Terrassa, 08221, Spain

Location

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

Location

Hospital Universitari I Politecnic La Fe

Valencia, 46026, Spain

Location

Hospital Universitario de Alava

Vitoria-Gasteiz, 01009, Spain

Location

Karolinska University Hospital Solna

Solna, 17164, Sweden

Location

Goetalandsregionen - Uddevalla Sjukhus Us

Uddevalla, 451 53, Sweden

Location

Uppsala Universitet - Akademiska Sjukhuset

Uppsala, 75185, Sweden

Location

University Hospital of Basel Department of Oncology

Basel, 04031, Switzerland

Location

Oncological Institute of Southern Switzerland

Bellinzona, 06500, Switzerland

Location

Inselspital - Universitaetsspital Bern

Bern, 03010, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 09007, Switzerland

Location

Kantonsspital Winterthur

Winterthur, 08401, Switzerland

Location

Universitatsspital Zurich

Zurich, 08091, Switzerland

Location

E-Da Hospital

Kaohsiung City, 00824, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 00833, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, 00220, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University (Ncku) Hospital

Tainan, 00704, Taiwan

Location

National Taiwan University Hospital

Taipei, 00100, Taiwan

Location

Tri Service General Hospital

Taipei, 00114, Taiwan

Location

Institutional Review Board Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Hematology and Medical Oncology Too Foundation Sun Yat Sen Cancer Center

Taipei, 11251, Taiwan

Location

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, 06100, Turkey (Türkiye)

Location

Ankara University Medical Faculty

Ankara, 06590, Turkey (Türkiye)

Location

Acibadem Maslak Hospital

Istanbul, 34457, Turkey (Türkiye)

Location

Communal Non-Profit Enterprise Regional Center of Oncology

Kharkiv, 61070, Ukraine

Location

National Cancer Institute of Ministry of Health

Kyiv, 03022, Ukraine

Location

University Hospitals Birmingham Nhs Foundation Trust

Birmingham, B15 2GW, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, BS2 8ED, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

The Royal Marsden Nhs Foundation Trust - Chelsea

London, SW3 6JJ, United Kingdom

Location

The Christie Nhs Foundation Trust Uk

Manchester, M20 4BX, United Kingdom

Location

James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

The Royal Marsden Nhs Foundation Trust - Sutton

Sutton, SM2 5PT, United Kingdom

Location

The Royal Wolverhampton Nhs Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (1)

  • 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. 2026 Jan 10;407(10524):133-146. doi: 10.1016/S0140-6736(25)01778-7. Epub 2025 Dec 5.

Related Links

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma, B-Cell, Marginal Zone

Interventions

tafasitamabRituximabLenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Study Director
Organization
Incyte Corporation

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 22, 2020

Study Start

April 15, 2021

Primary Completion

February 23, 2024

Study Completion (Estimated)

August 9, 2028

Last Updated

December 22, 2025

Results First Posted

April 4, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
More information

Locations