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 Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Incyte Corporation Call Center (ex-US); Phone Number: +800 00027423; Email: eumedinfo@incyte.com

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
  • Wien, Austria, 01090
    • *Krankenhaus*
• Belgium
  • Antwerpen, Belgium, 02060
    • ZNA Stuivenberg
  • Brugge, 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
  • Gent, 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
    • Montréal, Quebec, Canada, H1T 2M4
      • Hospital Maisonneuve Rosemont
    • Montréal, 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 Kralove, Czechia, 50333
    • University Hospital Hradec Kralove
  • Ostrava, Czechia, 70800
    • University Hospital Ostrava
  • Prague, Czechia, 128 08
    • Vseobecna Fakultní Nemocnice
  • Praha, Czechia, 10034
    • University Hospital Kralovkse Vinohrady
  • Praha, 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
    • Universitatsklinikum 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
  • Muenster, 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
  • Patras, 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 Aladar County Teaching Hospital
  • Nyíregyháza, Hungary, 04400
    • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
  • 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
  • Bear Sheva, Israel
    • Soroka
  • Beer Yaaqov, Israel, 70300
    • Shamir Medical Center Formerly Assaf Harofeh Medical Center
  • 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 Hashomer, 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
  • Milano, Italy, 20162
    • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Milano, Italy, 20133
    • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
  • Naples, Italy, 80131
    • Istituto Nazionale Tumori IRCCS Fondazione Pascale
  • Napoli, Italy, 80131
    • Universita Di Napoli Federico Ii
  • Novara, Italy, 28100
    • Azienda Ospedaliero Universitaria Maggiore Della Carita 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-shi, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
  • Fukuyama-shi, Japan, 720-0001
    • Chugoku Center Hospital
  • Gifu-shi, Japan, 500-8513
    • Gifu Municipal Hospital
  • Kagoshima-shi, 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-shi, Japan, 650-0047
    • Kobe City Medical Center General Hospital
  • Nagoya-shi, Japan, 466 8650
    • Japanese Red Cross Nagoya Daini Hospital
  • Narita City, 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-shi, Japan, 514-8507
    • Mie University Hospital
  • Yamagata-shi, Japan, 990-9585
    • Yamagata University Hospital
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Busan, Korea, Republic of, 47392
    • Inje University Busan Paik Hospital
  • Busan-si, Korea, Republic of, 03181
    • Pusan National University Yangsan Hospital
  • Busan-si, Korea, Republic of, 602-739
    • Pusan National University Yangsan Hospital
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital
  • Daegu, Korea, Republic of, 42472
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of, 42601
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University
  • Incheon, Korea, Republic of, 21565
    • Gacheon University Gil Medical Center
  • Jeonju, Korea, Republic of, 54907
    • Jeonbuk National University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 07345
    • The Catholic University of Korea Yeoido St.Mary'S 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
  • Brzozow, Poland, 36-200
    • Szpital Spec Brzozowiepoland
  • Katowice, Poland, 40-519
    • Pratia Poznan
  • 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
  • Tomaszow Mazowiecki, Poland, 97-200
    • Specjalistyczny Szpital Onkologiczny
  • Warszawa, Poland, 02-776
    • Institute of Hematology and Transfusion Medicine
  • Warszawa, Poland, 02-0781
    • Maria Sklodowska-Curie National Research Institute of Oncology
  • Wroclaw, Poland, 50-367
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
• Russian Federation
  • Rostov-on-don, Russian Federation, 344022
    • Rostov State Medical University
  • St.petersburg, Russian Federation, 196022
    • Pavlov First Saint Petersburg State Medical University
• 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
  • Gijon, Spain, 33394
    • Hospital Universitario de Cabueñes
  • Hospitalet de Llobregat, Spain, 08908
    • Institut Catala Doncologia Ico - Hospital Duran I Reynals Location
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz University Hospital
  • Madrid, Spain, 28223
    • Hospital Universitario Quirónsalud Madrid
  • Majadahonda, Spain, 28222
    • Hospital Puerta de Hierro
  • Malaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen de la Arrixaca
  • Palma de Mallorca, Spain, 07198
    • Hospital Son Llatzer
  • Sabadell, Spain, 08208
    • Consorci Hospitalari Parc Tauli de Sabadell
  • Salamanca, Spain, 37007
    • Hospital Clínico Universitario de Salamanca
  • Santander, Spain, 39008
    • Hospital Universitario Marques de Valdecilla
  • Sevilla, Spain, 41005
    • Hospital Universitario Virgen del Rocio 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
  • St. Gallen, Switzerland, 09007
    • Kantonsspital St. Gallen
  • Winterthur, Switzerland, 08401
    • Kantonsspital Winterthur
  • Zurich, Switzerland, 08091
    • Universitätsspital Zürich
• Taiwan
  • Kaohsiung, 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 City, Taiwan, 11251
    • Hematology and Medical Oncology Too Foundation Sun Yat Sen Cancer Center
• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe Universitesi Tip Fakultesi Hastanesi
  • Ankara, Turkey, 06590
    • Ankara University Medical Faculty
  • Istanbul, Turkey, 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
Progression Free Survival (PFS) in FL population	Defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.	Up to 6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) in FL and MZL populations	Defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.	Up to 6 years
Complete Response in FL population	Defined as number of participants with complete response par Positron Emission Tomography(PET) at the end of treatment visit	Up to 6 years
Minimal Residual Disease-negativity rate in FL and MZL Population	Defined as less than 1 residual tumor cell per 10^4 normal cells in peripheral blood and bone marrow.	14 months
Overall Survival in FL Population	Defined as survival from time of study randomization to death of any cause.	Up to 6 years
Complete Response in Overall population	Defined as number of participants with complete response par Positron Emission Tomography(PET) at the end of treatment visit	Up to 6 years
Overall Survival in overall Population	Defined as survival from time of study initiation to death of any cause.	Up to 6 years
Best Overall Response Rate in FL and overall population	Defined as proportion of participants whose best overall response was a complete response (CR) or partial response (PR).	Up to 6 years
Duration of Response in FL and overall population	Defined as the time to the first response to evidence of progression.	Up to 6 years
Quality-of-Life Assessments in FL and overall populations	Defined as a patient self evaluation questionnaire	Up to 6 years
Safety: Number of participants with TEAE's	Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 30 days after last dose of study treatment.	13 months

Collaborators and Investigators

• Sponsor: Incyte Corporation

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): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: MOR00208; INCMOR00208; tafasitamab
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide; Rituximab
• Other Study ID Numbers: INCMOR 0208-301

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