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. (InMIND)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Follicular Lymphoma; Marginal Zone Lymphoma
• Intervention / Treatment: Drug: tafasitamab; Drug: rituximab; Drug: lenalidomide; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 654
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Box Hill, Australia, 3128
    • Eastern Health
  • Hobart, Australia, 07000
    • Royal Hobart Hospital
  • New South Wales
    • Kogarah, New South Wales, Australia, 02217
      • St George Hospital
    • Sydney, New South Wales, Australia, 02170
      • Liverpool Hospital
    • Wollongong, New South Wales, Australia, 02500
      • Wollongong Hospital - Illawarra Regional Hospital
  • Queensland
    • Southport, Queensland, Australia, 04215
      • Gold Coast Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 05000
      • Royal Adelaide Hospital
    • Bedford Park, South Australia, Australia, 05042
      • Flinders Medical Centre
  • Victoria
    • Melbourne, Victoria, Australia, 03004
      • The Alfred Hospital
    • Melbourne, Victoria, Australia, 03076
      • Northern Hospital
    • St Albans, Victoria, Australia, 03021
      • Western Health
  • Western Australia
    • West Perth, Western Australia, Australia, 06005
      • Perth Blood Institute
• Austria
  • Graz, Austria, 08036
    • Landeskrankenhaus Universitatsklinikum Graz
  • Innsbruck, Austria, 06020
    • Innsbruck University Hospital
  • Linz, Austria, 04020
    • Kepler Universitat Klinikum
  • Vienna, Austria, 01090
    • *Krankenhaus*
• Belgium
  • Antwerp, Belgium, 02060
    • ZNA Stuivenberg
  • Bruges, Belgium, 8000
    • A.Z. St.-Jan-Dienst Hematologie
  • Brussels, Belgium, 01000
    • Institut Jules Bordet
  • Brussels, Belgium, 01200
    • Cliniques Universitaires Ucl Saint-Luc
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen, Dienst Hematologie
  • Ghent, Belgium, 09000
    • Ghent University Hospital
  • Leuven, Belgium, 03000
    • Universitair Ziekenhuis (Uz) Leuven
  • Liège, Belgium, 04000
    • Centre Hospitalier Universitaire de Liege - Sart Tilman
  • Roeselare, Belgium, 8800
    • AZ Delta
  • Yvoir, Belgium, 05530
    • Chu Ucl Namur University Hospital Mont-Godinne
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1L3
      • British Columbia Cancer Agency
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Hospital Maisonneuve Rosemont
    • Montreal, Quebec, Canada, H3T 1E2
      • McGill University Jewish General Hospital
    • Québec, Quebec, Canada, G1J 1Z4
      • Chu de Quebec - Universite Laval (Chul)
• Czechia
  • Brno, Czechia, 62500
    • University
  • Hradec Králové, Czechia, 50333
    • University hospital Hradec Králové
  • Ostrava, Czechia, 70800
    • University Hospital Ostrava
  • Prague, Czechia, 10034
    • University Hospital Kralovkse Vinohrady
  • Prague, Czechia, 128 08
    • Vseobecna Fakultni Nemocnice
  • Prague, Czechia, 15000
    • University Hospital Motol
• Denmark
  • Aalborg, Denmark, 09000
    • Aalborg University Hospital
  • Aarhus, Denmark, 08200
    • Aarhus University Hospital
  • Odense, Denmark, 05000
    • Odense University Hospital
  • Roskilde, Denmark, 04000
    • Sjaellands Universitetshospital Naestved
• Finland
  • Kuopio, Finland, 70210
    • Kuopio University Hospital
  • Oulu, Finland, 90220
    • Oulu University Hospital
  • Tampere, Finland, 33520
    • Tampere University Hospital
  • Turku, Finland, 20520
    • Turku University Hospital
• France
  • Amiens, France, 80054
    • Chu Amiens Picardie - Hopital Sud
  • Angers, France, 49933
    • Chu Angers Hotel Dieu Nord
  • Bordeaux, France, 33000
    • Groupe Bordeaux Nord Aquitaine Gbna Polycliniques - Polyclinique Bordeaux Nord Aquitaine Pbna
  • Dijon, France, 21000
    • Centre Hospitalier Universitaire Chu Dijon Bourgogne - Hopital Francois Mitterrand
  • Le Chesnay, France, 78150
    • Centre Hospitalier de Versailles - Hopital Andre Mignot
  • Nantes, France, 44093
    • CHU Nantes
  • Paris, France, 75651
    • Hopital Pitie Salpetriere
  • Paris, France, 75014
    • A.P.H. Paris Hopital Cochin
  • Paris, France, 75010
    • Hospital Saint-Louis Service Oncologie Medicale
  • Pontoise, France, 95303
    • Centre Hospitalier de Pontoise
  • Pringy, France, 74374
    • Centre Hospitalier Annecy-Genevois
  • Tours, France, 37044
    • Chru Hopitaux de Tours Hospital Bretonneau
• Germany
  • Amberg, Germany, 92224
    • Klinikum St. Marien Amberg
  • Berlin, Germany, 10967
    • Klinik fur Innere Medizin Hamatologie and Onkologie
  • Essen, Germany, 45147
    • Universitätsklinikum Essen
  • Giessen, Germany, 35392
    • University Clinic Giessen Und Marburg Ukgm
  • Greifswald, Germany, 17475
    • Universitaetsmedizin Greifswald
  • Landshut, Germany, 84036
    • Statistics and Data Corporation (Sdc)
  • Mainz, Germany, 55131
    • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
  • Mannheim, Germany, 68167
    • Medizinische Fakultaet Mannheim Der Universitaet Heidelberg
  • Münster, Germany, 48149
    • Universitatsklinikum Munster
  • Oldenburg, Germany, 26121
    • Onkologische Schwerpunktpraxis
  • Ulm, Germany, 89081
    • Universitarsfrauenklinik Ulm
  • Würzburg, Germany, 97080
    • Universitaetsklinikum Wuerzburg
• Greece
  • Athens, Greece, 11527
    • General Hospital of Athens Laiko
  • Athens, Greece, 11525
    • 251 Air Force General Hospital
  • Athens, Greece, 12462
    • University Hospital of West Attica - Attikon
  • Pátrai, Greece, 26504
    • University General Hospital of Patras
• Hungary
  • Budapest, Hungary, 01122
    • National Institute of Oncology
  • Budapest, Hungary, 01088
    • Semmelweis Egyetem
  • Debrecen, Hungary, 04032
    • Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
  • Eger, Hungary, 03300
    • Markhot Ferenc Korhaz
  • Győr, Hungary, 09024
    • Petz Aladár County Teaching Hospital
  • Nyíregyháza, Hungary, 04400
    • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
  • Szeged, Hungary, 06725
    • University of Szeged
• Ireland
  • Dublin, Ireland, D9 V2N0
    • Beaumont Hospital
  • Galway, Ireland, H91 YR71
    • University Hospital Galway
• Israel
  • Afula, Israel, 18105
    • Ha Emek Medical Center
  • BEER Yaaqov, Israel, 70300
    • Shamir Medical Center Formerly Assaf Harofeh Medical Center
  • Bear Sheva, Israel
    • Soroka
  • Holon, Israel, 5822012
    • Wolfson
  • Jerusalem, Israel, 9103102
    • Shaare Zedek MC
  • Jerusalem, Israel, 91120
    • "Laiko" General Hospital of Athens, Hematology of the First Propaedeutic Internal Medicine Clinic
  • Jerusalem, Israel, 91120
    • Hadassah
  • Kfar Saba, Israel, 44281
    • Meir Medical Center
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center - Beilinson Hospital
  • Tel Litwinsky, Israel, 5265601
    • Sheba Medical Center
• Italy
  • Bari, Italy, 70124
    • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
  • Brescia, Italy, 25123
    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  • Brescia, Italy, 25123
    • Divisione Clinicizzata Di Ematologia
  • Candiolo, Italy, 10060
    • Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
  • Catania, Italy, 95123
    • Divisione Clinicizzata Di Ematologia
  • Lecce, Italy, 73100
    • Presidio Ospedaliero Vito Fazzi
  • Milan, Italy, 20162
    • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Milan, Italy, 20133
    • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
  • Naples, Italy, 80131
    • Istituto Nazionale Tumori IRCCS Fondazione Pascale
  • Napoli, Italy, 80131
    • Università di Napoli Federico II
  • Novara, Italy, 28100
    • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
  • Orbassano, Italy, 10043
    • Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
  • Palermo, Italy, 90146
    • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo
  • Piacenza, Italy, 29100
    • Ausl Di Placenza Ospedale Guglielmo Da Saliceto
  • Pisa, Italy, 56126
    • Uo Ematologia Univ - Aoup Santa Chiara Pisa
  • Ravenna, Italy, 48121
    • Ospedale Santa Maria delle Croci
  • Reggio Emilia, Italy, 42100
    • Arcispedale Santa Maria Nuova
  • Rimini, Italy, 47923
    • AUSL della Romagna
  • Roma, Italy, 00161
    • Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma - Centro di Ematologia
  • Rome, Italy, 00144
    • Ospedale Sant. Eugenio
  • San Martino, Italy, 16132
    • Irccs Azienda Ospedaliera Universitaria San Martino
  • Torino, Italy, 10126
    • Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
  • Trieste, Italy, 34125
    • Asugi Ospedale Maggiore
• Japan
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
  • Fukuyama-shi, Japan, 720-0001
    • Chugoku Center Hospital
  • Gifu, Japan, 500-8513
    • Gifu Municipal Hospital
  • Kagoshima, Japan, 890-8520
    • Kagoshima University Hospital
  • Kashiwa-shi, Japan, 277-8577
    • National Cancer Center Hospital East
  • Kitakyushu-shi, Japan, 807-8556
    • Hospital of the University of Occupation and Environmental Health
  • Kobe, Japan, 650-0047
    • Kobe City Medical Center General Hospital
  • Nagoya, Japan, 466 8650
    • Japanese Red Cross Nagoya Daini Hospital
  • Narita, Japan, 286-8520
    • IUHW Narita Hospital
  • Osakasayama-shi, Japan, 589-8511
    • Kindai University Hospital
  • Saitama, Japan, 350-0495
    • Saitama Medical University Hospital
  • Suita-shi, Japan, 565-0871
    • Osaka University Hospital
  • Tokyo, Japan, 113-8431
    • Juntendo University Hospital
  • Tsu, Japan, 514-8507
    • Mie University Hospital
  • Yamagata, Japan, 990-9585
    • Yamagata University Hospital
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Amsterdam University Medical Centre
  • Arnhem, Netherlands, 6815 AD
    • Hospital Rijnstate
  • Enschede, Netherlands, 7512 KZ
    • Medisch Spectrum Twente
  • Leeuwarden, Netherlands, 8934 AD
    • Medisch Centrum Leeuwarden
  • Leidschendam, Netherlands, 2622BA
    • HMC
• Norway
  • Brumunddal, Norway, 02381
    • Innlandet Hospital Trust
  • Trondheim, Norway, 07006
    • Universitetssykehuset I Trondheim - St. Olavs Hospital
• Poland
  • Brzozów, Poland, 36-200
    • Szpital Spec Brzozowiepoland
  • Katowice, Poland, 40-519
    • Pratia Poznań
  • Krakow, Poland, 31-501
    • Sp Zoz Szpital Uniwersytecki
  • Krakow, Poland, 30-225
    • Pratia MCM Krakow
  • Lodz, Poland, 93-510
    • Uniwersytet Medyczny W Lodzi - Klinika Hematologii
  • Lublin, Poland, 20-081
    • Samodzielny Publiczny Szpital Kliniczny nr 1
  • Tomaszów Mazowiecki, Poland, 97-200
    • Specjalistyczny Szpital Onkologiczny
  • Warsaw, Poland, 02-776
    • Institute of Hematology and Transfusion Medicine
  • Warsaw, Poland, 02-0781
    • Maria Sklodowska-Curie National Research Institute of Oncology
  • Wroclaw, Poland, 50-367
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
• Russia
  • Rostov-on-Don, Russia, 344022
    • Rostov State Medical University
  • Saint Petersburg, Russia, 196022
    • Pavlov First Saint Petersburg State Medical University
• South Korea
  • Busan, South Korea, 49201
    • Dong-A University Hospital
  • Busan, South Korea, 47392
    • Inje University Busan Paik Hospital
  • Busan, South Korea, 03181
    • Pusan National University Yangsan Hospital
  • Busan, South Korea, 602-739
    • Pusan National University Yangsan Hospital
  • Daegu, South Korea, 42472
    • Daegu Catholic University Medical Center
  • Daegu, South Korea, 41944
    • Kyungpook National University Hospital
  • Daegu, South Korea, 42601
    • Keimyung University Dongsan Medical Center
  • Daejeon, South Korea, 35015
    • Chungnam National University
  • Incheon, South Korea, 21565
    • Gacheon University Gil Medical Center
  • Jeonju, South Korea, 54907
    • Jeonbuk National University Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 07345
    • The Catholic University of Korea Yeoido St.Mary'S Hospital
• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña
  • Alicante, Spain, 03010
    • Hospital General Unviersitario de Alicante
  • Badalona, Spain, 08916
    • ICO Hospital Germans Trias i Pujol
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08041
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain, 08007
    • Hospital General Universitario Vall D Hebron
  • Burgos, Spain, 09006
    • Hospital Universitario de Burgos
  • Gijón, Spain, 33394
    • Hospital Universitario de Cabueñes
  • L'Hospitalet de Llobregat, Spain, 08908
    • Institut Catala Doncologia Ico - Hospital Duran I Reynals Location
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz University Hospital
  • Madrid, Spain, 28223
    • Hospital Universitario Quirónsalud Madrid
  • Majadahonda, Spain, 28222
    • Hospital Puerta de Hierro
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen de La Arrixaca
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Palma de Mallorca, Spain, 07198
    • Hospital Son Llàtzer
  • Sabadell, Spain, 08208
    • Consorci Hospitalari Parc Tauli de Sabadell
  • Salamanca, Spain, 37007
    • Hospital Clínico Universitario de Salamanca
  • Santander, Spain, 39008
    • Hospital Universitario Marqués de Valdecilla
  • Seville, Spain, 41005
    • Hospital Universitario Virgen Del Rocío Sevilla
  • Terrassa, Spain, 08221
    • Hospital Universitari Mutua Terrassa
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Valencia, Spain, 46017
    • Hospital Universitario Doctor Peset
  • Vitoria-Gasteiz, Spain, 01009
    • Hospital Universitario de Alava
• Sweden
  • Solna, Sweden, 17164
    • Karolinska University Hospital Solna
  • Uddevalla, Sweden, 451 53
    • Goetalandsregionen - Uddevalla Sjukhus Us
  • Uppsala, Sweden, 75185
    • Uppsala Universitet - Akademiska Sjukhuset
• Switzerland
  • Basel, Switzerland, 04031
    • University Hospital of Basel Department of Oncology
  • Bellinzona, Switzerland, 06500
    • Oncological Institute of Southern Switzerland
  • Bern, Switzerland, 03010
    • Inselspital - Universitaetsspital Bern
  • Sankt Gallen, Switzerland, 09007
    • Kantonsspital St. Gallen
  • Winterthur, Switzerland, 08401
    • Kantonsspital Winterthur
  • Zurich, Switzerland, 08091
    • UniversitätsSpital Zürich
• Taiwan
  • Kaohsiung City, Taiwan, 00833
    • Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung City, Taiwan, 00824
    • E-Da hospital
  • New Taipei City, Taiwan, 00220
    • Far Eastern Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Tainan, Taiwan, 00704
    • National Cheng Kung University (NCKU) Hospital
  • Taipei, Taiwan, 00100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 00114
    • Tri Service General Hospital
  • Taipei, Taiwan, 11217
    • Institutional Review Board Taipei Veterans General Hospital
  • Taipei, Taiwan, 11251
    • Hematology and Medical Oncology Too Foundation Sun Yat Sen Cancer Center
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06100
    • Hacettepe Universitesi Tip Fakultesi Hastanesi
  • Ankara, Turkey (Türkiye), 06590
    • Ankara University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34457
    • Acibadem Maslak Hospital
• Ukraine
  • Kharkiv, Ukraine, 61070
    • Communal Non-Profit Enterprise Regional Center of Oncology
  • Kyiv, Ukraine, 03022
    • National Cancer Institute of Ministry of Health
• United Kingdom
  • Birmingham, United Kingdom, B15 2GW
    • University Hospitals Birmingham NHS Foundation Trust
  • Bristol, United Kingdom, BS2 8ED
    • Bristol Haematology and Oncology Centre
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden Nhs Foundation Trust - Chelsea
  • Manchester, United Kingdom, M20 4BX
    • The Christie Nhs Foundation Trust Uk
  • Middlesbrough, United Kingdom, Ts4 3Bw
    • James Cook University Hospital
  • Sutton, United Kingdom, SM2 5PT
    • The Royal Marsden Nhs Foundation Trust - Sutton
  • Wolverhampton, United Kingdom, WV10 0QP
    • The Royal Wolverhampton NHS Trust
• United States
  • California
    • Concord, California, United States, 94520-2266
      • John Muir Health Clinical Research Center
    • Greenbrae, California, United States, 94904
      • Marin Cancer Care
    • Pasadena, California, United States, 91105
      • The Oncology Institute of Hope and Innovation
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
  • Connecticut
    • Middletown, Connecticut, United States, 06457
      • Middlesex Hospital Cancer Center
    • New Haven, Connecticut, United States, 06510
      • Smilow Cancer Hospital
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of North Florida
    • Plantation, Florida, United States, 33322
      • BRCR Medical Center, Inc
    • Weeki Wachee, Florida, United States, 34607
      • Asclepes Research Centers
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers,P.C
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Straub Medical Center
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Des Moines Oncology Research Association
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland-Greenebaum Cancer Center
    • Bethesda, Maryland, United States, 20817
      • Cancer Center For Blood Disorders
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Hospital
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Metro-Minnesota Community Oncology Reserch Consortium (Mmcorc)
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic Hematology
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10016
      • NYU Clinical Cancer Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73142
      • Integris Cancer Institute
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Hematology Oncology Associates
    • Greenville, South Carolina, United States, 29615
      • Prisma Health Upstate
  • South Dakota
    • Watertown, South Dakota, United States, 57201
      • Prairie Lakes Health Care System, Inc.
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology-Baylor Charles A. Sammons
    • Fort Worth, Texas, United States, 76104
      • The Center for Cancer and Blood Disorders
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • Houston, Texas, United States, 77026
      • Lyndon B Johnson General Hospital
    • Spring, Texas, United States, 77380
      • Renovatio Clinical
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Utah Cancer Specialists
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center
  • Washington
    • Olympia, Washington, United States, 98506
      • Vista Oncology Inc PS
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98109-4405
      • University of Washington-Seattle Cancer Care Alliance
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: tafasitamab; tafasitamab will be administered IV for 12 cycles; Other Names: MOR00208; INCMOR00208; Drug: rituximab; Rituximab will be administered IV on cycles 1 - 5; Drug: lenalidomide; Lenalidomide will be administered PO for 12 cycles
Placebo Comparator: 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)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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
FDG-avid FL Population: Positron Emission Tomography-Complete Response (PET-CR) Rate by Investigator Assessment, Using the Lugano 2014 Criteria	CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma.	up to approximately 34 months
FL Population: Overall Survival	Overall survival was defined as the time from randomization until death from any cause.	up to approximately 34 months
FL Population: Kaplan-Meier Estimates of Overall Survival	Overall survival was defined as the time from randomization until death from any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.	up to 2 years
FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria	CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma. The Overall FDG-avid Set included all randomized participants with a PET scan at Baseline with a resulting Deauville score of 4 or 5.	up to approximately 34 months
FL Population: Minimal Residual Disease (MRD)-Negativity Rate (at Threshold of 10^-5) at End of Treatment	The MRD-negativity rate was defined as the percentage of participants who achieved a negative MRD result in peripheral blood at the End of Treatment. The threshold used for the analysis was 10^-5 cells. MRD status was only analyzed with a threshold of ≤10^-5 cells for MRD negativity.	up to approximately 34 months
Overall Population: MRD-negativity Rate (at Threshold of 10-5) at End of Treatment	The MRD-negativity rate was defined as the percentage of participants who achieved a negative MRD result in peripheral blood at the End of Treatment. The threshold used for the analysis was 10^-5 cells. MRD status was only analyzed with a threshold of ≤10^-5 cells for MRD negativity. The Overall MRD Blood-Evaluable Set included all participants in the Full Analysis Set who received at least 1 dose of study treatment with identifiable clonality in blood samples at Cycle 1 Day 1.	up to approximately 34 months
FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment	PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake > mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by >50% in length beyond normal; (4) no new lesions.	up to approximately 34 months
Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment	PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake > mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by >50% in length beyond normal; (4) no new lesions.	up to approximately 34 months
FL Population: Duration of Response (DOR; the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment	PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake > mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by >50% in length beyond normal; (4) no new lesions.	up to approximately 34 months
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment	PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake > mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by >50% in length beyond normal; (4) no new lesions.	up to 2 years
Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment	PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake > mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by >50% in length beyond normal; (4) no new lesions.	up to approximately 34 months
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment	PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake > mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by >50% in length beyond normal; (4) no new lesions.	up to 2 years
Overall Population: Overall Survival	Overall survival was defined as the time from randomization until death from any cause.	up to approximately 34 months
Overall Population: Kaplan-Meier Estimates of Overall Survival	Overall survival was defined as the time from randomization until death from any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.	up to 2 years
FL Population: PFS by IRC Review, 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.	up to approximately 34 months
FL Population: Kaplan-Meier Estimates of PFS by IRC Review, 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
Overall Population: PFS by IRC Review, 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.	up to approximately 34 months
Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, 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
FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review	PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake > mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by >50% in length beyond normal; (4) no new lesions.	up to approximately 34 months
Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review	PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake > mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by >50% in length beyond normal; (4) no new lesions.	up to approximately 34 months
FL Population: DOR the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review	PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake > mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by >50% in length beyond normal; (4) no new lesions.	up to approximately 34 months
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review	PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake > mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by >50% in length beyond normal; (4) no new lesions.	up to 2 years
Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review	PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake > mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by >50% in length beyond normal; (4) no new lesions.	up to approximately 34 months
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review	PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake > mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by >50% in length beyond normal; (4) no new lesions.	up to 2 years
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment	The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) version 3 is a 30-item scale composed of both multi-item scales and single-item measures. These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial). All scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.	up to approximately 34 months
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment	The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) version 3 is a 30-item scale composed of both multi-item scales and single-item measures. These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial). All scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.	up to approximately 34 months
FL Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment	The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 [worst imaginable health state] to 100 [best imaginable health state]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.	up to approximately 34 months
Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment	The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 [worst imaginable health state] to 100 [best imaginable health state]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.	up to approximately 34 months
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment	The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 [worst imaginable health state] to 100 [best imaginable health state]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.	up to approximately 34 months
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment	The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 [worst imaginable health state] to 100 [best imaginable health state]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.	up to approximately 34 months
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment	The FACT-Lymphoma (v4) is composed of 42 items with a 5-point Likert-type scale and 5 subscales. Physical well-being (PWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Social/family well-being (SWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Emotional well-being (EWB) subscale: 6 items measured on 0- to 4-point scale; total score = 0-24. Functional well-being (FWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Lymphoma (LymS) subscale includes 15 items; total score = 0-60. Three total scores can be derived by adding the subscales: FACT-Lymphoma Trial Outcome Index (TOI): (PWB score) + (FWB score) + (LymS score); total score = 0-116. FACT-G total score: (PWB score) + (SWB score) + (EWB score) + (FWB score); total score = 0-108. FACT-Lymphoma total score: (PWB score) + (SWB score) + (EWB score) + (FWB score) + (LymS score); total score = 0-168. The higher the score, the better the quality of life.	up to approximately 34 months
Overall Population: FACT-Lym Scores at Baseline and End of Treatment	The FACT-Lymphoma (v4) is composed of 42 items with a 5-point Likert-type scale and 5 subscales. Physical well-being (PWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Social/family well-being (SWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Emotional well-being (EWB) subscale: 6 items measured on 0- to 4-point scale; total score = 0-24. Functional well-being (FWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Lymphoma (LymS) subscale includes 15 items; total score = 0-60. Three total scores can be derived by adding the subscales: FACT-Lymphoma Trial Outcome Index (TOI): (PWB score) + (FWB score) + (LymS score); total score = 0-116. FACT-G total score: (PWB score) + (SWB score) + (EWB score) + (FWB score); total score = 0-108. FACT-Lymphoma total score: (PWB score) + (SWB score) + (EWB score) + (FWB score) + (LymS score); total score = 0-168. The higher the score, the better the quality of life.	up to approximately 34 months

Collaborators and Investigators

• Sponsor: Incyte Corporation

Publications and helpful links

General Publications

• 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.

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Actual): February 23, 2024
• Study Completion (Estimated): August 9, 2028

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: MOR00208; INCMOR00208; tafasitamab
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Piperidines; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide; Rituximab; tafasitamab
• Other Study ID Numbers: INCMOR 0208-301; 2020-004407-13 (EudraCT Number); 2023-504684-16-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No