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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04680052
Other study ID # INCMOR 0208-301
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date April 15, 2021
Est. completion date August 9, 2028

Study information

Verified date March 2024
Source Incyte Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 654
Est. completion date August 9, 2028
Est. primary completion date February 23, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
tafasitamab
tafasitamab will be administered IV for 12 cycles
rituximab
Rituximab will be administered IV on cycles 1 - 5
lenalidomide
Lenalidomide will be administered PO for 12 cycles
placebo
placebo will be administered IV for 12 cycles

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Flinders Medical Centre Bedford Park South Australia
Australia Eastern Health Box Hill
Australia Royal Hobart Hospital Hobart
Australia St George Hospital Kogarah New South Wales
Australia Northern Hospital Melbourne Victoria
Australia The Alfred Hospital Melbourne Victoria
Australia Gold Coast Hospital Southport Queensland
Australia Western Health St. Albans Victoria
Australia Liverpool Hospital Sydney New South Wales
Australia Perth Blood Institute West Perth Western Australia
Australia Wollongong Hospital - Illawarra Regional Hospital Wollongong New South Wales
Austria Landeskrankenhaus Universitatsklinikum Graz Graz
Austria Innsbruck University Hospital Innsbruck
Austria Kepler Universitat Klinikum Linz
Austria *Krankenhaus* Wien
Belgium Zna Stuivenberg Antwerpen
Belgium A.Z. St.-Jan-Dienst Hematologie Brugge
Belgium Cliniques Universitaires Ucl Saint-Luc Brussels
Belgium Institut Jules Bordet Brussels
Belgium Universitair Ziekenhuis Antwerpen, Dienst Hematologie Edegem
Belgium Ghent University Hospital Gent
Belgium Universitair Ziekenhuis (Uz) Leuven Leuven
Belgium Centre Hospitalier Universitaire de Liege - Sart Tilman Liège
Belgium AZ Delta Roeselare
Belgium Chu Ucl Namur University Hospital Mont-Godinne Yvoir
Canada Cross Cancer Institute Edmonton Alberta
Canada Queen Elizabeth Ii Health Sciences Centre Halifax Nova Scotia
Canada London Health Sciences Centre London Ontario
Canada Hospital Maisonneuve Rosemont Montréal Quebec
Canada McGill University Jewish General Hospital Montréal Quebec
Canada Chu de Quebec - Universite Laval (Chul) Québec Quebec
Canada British Columbia Cancer Agency Vancouver British Columbia
Czechia University Brno
Czechia University Hospital Hradec Kralove Hradec Kralove
Czechia University Hospital Ostrava Ostrava
Czechia Vseobecna Fakultni Nemocnice Prague
Czechia University Hospital Kralovkse Vinohrady Praha
Czechia University Hospital Motol Praha
Denmark Aalborg University Hospital Aalborg
Denmark Aarhus University Hospital Aarhus
Denmark Odense University Hospital Odense
Denmark Sjaellands Universitetshospital Naestved Roskilde
Finland Kuopio University Hospital Kuopio
Finland Oulu University Hospital Oulu
Finland Tampere University Hospital Tampere
Finland Turku University Hospital Turku
France Chu Amiens Picardie - Hopital Sud Amiens
France Chu Angers Hotel Dieu Nord Angers
France Groupe Bordeaux Nord Aquitaine Gbna Polycliniques - Polyclinique Bordeaux Nord Aquitaine Pbna Bordeaux
France Centre Hospitalier Universitaire Chu Dijon Bourgogne - Hopital Francois Mitterrand Dijon
France Centre Hospitalier de Versailles - Hopital Andre Mignot Le Chesnay
France CHU Nantes Nantes
France A.P.H. Paris Hopital Cochin Paris
France Hôpital Pitié Salpêtrière Paris
France Hospital Saint-Louis Service Oncologie Medicale Paris
France Centre Hospitalier de Pontoise Pontoise
France Centre Hospitalier Annecy-Genevois Pringy
France Chru Hopitaux de Tours Hospital Bretonneau Tours
Germany Klinikum St. Marien Amberg Amberg
Germany Klinik Fur Innere Medizin Hamatologie and Onkologie Berlin
Germany Universitatsklinikum Essen Essen
Germany University Clinic Giessen Und Marburg Ukgm GIEßEN
Germany Universitaetsmedizin Greifswald Greifswald
Germany Statistics and Data Corporation (Sdc) Landshut
Germany Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii Mainz
Germany Medizinische Fakultaet Mannheim Der Universitaet Heidelberg Mannheim
Germany Universitatsklinikum Munster Muenster
Germany Onkologische Schwerpunktpraxis Oldenburg
Germany Universitarsfrauenklinik Ulm ULM
Germany Universitaetsklinikum Wuerzburg Würzburg
Greece 251 Air Force General Hospital Athens
Greece General Hospital of Athens Laiko Athens
Greece University Hospital of West Attica - Attikon Athens
Greece University General Hospital of Patras Patras
Hungary National Institute of Oncology Budapest
Hungary Semmelweis Egyetem Budapest
Hungary Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika Debrecen
Hungary Markhot Ferenc Korhaz Eger
Hungary Petz Aladar County Teaching Hospital Gyor
Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz Nyíregyháza
Hungary University of Szeged Szeged
Ireland Beaumont Hospital Dublin
Ireland University Hospital Galway Galway
Israel Ha Emek Medical Center Afula
Israel Soroka Bear Sheva
Israel Shamir Medical Center Formerly Assaf Harofeh Medical Center Beer Yaaqov
Israel Wolfson Holon
Israel "Laiko" General Hospital of Athens, Hematology of the First Propaedeutic Internal Medicine Clinic Jerusalem
Israel Hadassah Jerusalem
Israel Shaare Zedek Mc Jerusalem
Israel Meir Medical Center Kfar Saba
Israel Rabin Medical Center - Beilinson Hospital Petah Tikva
Israel Sheba Medical Center Tel Hashomer
Italy Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari Bari
Italy Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia Brescia
Italy Divisione Clinicizzata Di Ematologia Brescia
Italy Fondazione Del Piemonte Per L Oncologia Ircc Candiolo Candiolo
Italy Divisione Clinicizzata Di Ematologia Catania
Italy Presidio Ospedaliero Vito Fazzi Lecce
Italy Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Milano
Italy Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano Milano
Italy Istituto Nazionale Tumori Irccs Fondazione Pascale Naples
Italy Universita Di Napoli Federico Ii Napoli
Italy Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara Novara
Italy Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano Orbassano
Italy Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Palermo
Italy Fondazione Irccs Policlinico San Matteo Pavia
Italy Ausl Di Placenza Ospedale Guglielmo Da Saliceto Piacenza
Italy Uo Ematologia Univ - Aoup Santa Chiara Pisa Pisa
Italy Ospedale Santa Maria Delle Croci Ravenna
Italy Arcispedale Santa Maria Nuova Reggio Emilia
Italy Ausl Della Romagna Rimini
Italy Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia Roma
Italy Ospedale Sant. Eugenio Rome
Italy Irccs Azienda Ospedaliera Universitaria San Martino San Martino
Italy Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Torino
Italy Asugi Ospedale Maggiore Trieste
Japan National Hospital Organization Kyushu Cancer Center Fukuoka-shi
Japan Chugoku Center Hospital Fukuyama-shi
Japan Gifu Municipal Hospital Gifu-shi
Japan Kagoshima University Hospital Kagoshima-shi
Japan National Cancer Center Hospital East Kashiwa-shi
Japan Hospital of the University of Occupation and Environmental Health Kitakyushu-shi
Japan Kobe City Medical Center General Hospital Kobe-shi
Japan Japanese Red Cross Nagoya Daini Hospital Nagoya-shi
Japan Iuhw Narita Hospital Narita City
Japan Kindai University Hospital Osakasayama-shi
Japan Saitama Medical University Hospital Saitama
Japan Osaka University Hospital Suita-shi
Japan Juntendo University Hospital Tokyo
Japan Mie University Hospital Tsu-shi
Japan Yamagata University Hospital Yamagata-shi
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Pusan National University Yangsan Hospital Busan-si
Korea, Republic of Pusan National University Yangsan Hospital Busan-si
Korea, Republic of Daegu Catholic University Medical Center Daegu
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Chungnam National University Daejeon
Korea, Republic of Gacheon University Gil Medical Center Incheon
Korea, Republic of Jeonbuk National University Hospital Jeonju
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Yonsei University Health System Seoul
Korea, Republic of The Catholic University of Korea Yeoido St.Mary'S Hospital Seoul
Netherlands Amsterdam University Medical Centre Amsterdam
Netherlands Hospital Rijnstate Arnhem
Netherlands Medisch Spectrum Twente Enschede
Netherlands Medisch Centrum Leeuwarden Leeuwarden
Netherlands HMC Leidschendam
Norway Innlandet Hospital Trust Brumunddal
Norway Universitetssykehuset I Trondheim - St. Olavs Hospital Trondheim
Poland Szpital Spec Brzozowiepoland Brzozow
Poland Pratia Poznan Katowice
Poland Pratia McM Krakow Krakow
Poland Sp Zoz Szpital Uniwersytecki Krakow
Poland Uniwersytet Medyczny W Lodzi - Klinika Hematologii Lodz
Poland Samodzielny Publiczny Szpital Kliniczny Nr 1 Lublin
Poland Specjalistyczny Szpital Onkologiczny Tomaszow Mazowiecki
Poland Institute of Hematology and Transfusion Medicine Warszawa
Poland Maria Sklodowska-Curie National Research Institute of Oncology Warszawa
Poland Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego Wroclaw
Russian Federation Rostov State Medical University Rostov-on-don
Russian Federation Pavlov First Saint Petersburg State Medical University St.petersburg
Spain Complejo Hospitalario Universitario A Coruna A Coruña
Spain Hospital General Unviersitario de Alicante Alicante
Spain Ico Hospital Germans Trias I Pujol Badalona
Spain Hospital de La Santa Creu I Sant Pau Barcelona
Spain Hospital Del Mar Barcelona
Spain Hospital General Universitario Vall D Hebron Barcelona
Spain Hospital Universitario de Burgos Burgos
Spain Hospital Universitario de Cabuenes Gijon
Spain Institut Catala Doncologia Ico - Hospital Duran I Reynals Location Hospitalet de Llobregat
Spain Fundacion Jimenez Diaz University Hospital Madrid
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Quironsalud Madrid Madrid
Spain Hospital Universitario Ramon Y Cajal Madrid
Spain Hospital Puerta de Hierro Majadahonda
Spain Hospital Universitario Virgen de La Victoria Malaga
Spain Hospital Universitario Virgen de La Arrixaca Murcia
Spain Hospital Son Llatzer Palma de Mallorca
Spain Consorci Hospitalari Parc Tauli de Sabadell Sabadell
Spain Hospital Clinico Universitario de Salamanca Salamanca
Spain Hospital Universitario Marques de Valdecilla Santander
Spain Hospital Universitario Virgen del Rocio Sevilla Sevilla
Spain Hospital Universitari Mutua Terrassa Terrassa
Spain Hospital Universitari I Politecnic La Fe Valencia
Spain Hospital Universitario Doctor Peset Valencia
Spain Hospital Universitario de Alava Vitoria-gasteiz
Sweden Karolinska University Hospital Solna Solna
Sweden Goetalandsregionen - Uddevalla Sjukhus Us Uddevalla
Sweden Uppsala Universitet - Akademiska Sjukhuset Uppsala
Switzerland University Hospital of Basel Department of Oncology Basel
Switzerland Oncological Institute of Southern Switzerland Bellinzona
Switzerland Inselspital - Universitaetsspital Bern Bern
Switzerland Kantonsspital St. Gallen St. Gallen
Switzerland Kantonsspital Winterthur Winterthur
Switzerland Universitatsspital Zurich Zurich
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung
Taiwan E-Da Hospital Kaohsiung City
Taiwan Far Eastern Memorial Hospital New Taipei City
Taiwan China Medical University Hospital Taichung
Taiwan National Cheng Kung University (Ncku) Hospital Tainan
Taiwan Institutional Review Board Taipei Veterans General Hospital Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Tri Service General Hospital Taipei
Taiwan Hematology and Medical Oncology Too Foundation Sun Yat Sen Cancer Center Taipei City
Turkey Ankara University Medical Faculty Ankara
Turkey Hacettepe Universitesi Tip Fakultesi Hastanesi Ankara
Turkey Acibadem Maslak Hospital Istanbul
Ukraine Communal Non-Profit Enterprise Regional Center of Oncology Kharkiv
Ukraine National Cancer Institute of Ministry of Health Kyiv
United Kingdom University Hospitals Birmingham Nhs Foundation Trust Birmingham
United Kingdom Bristol Haematology and Oncology Centre Bristol
United Kingdom Leicester Royal Infirmary Leicester
United Kingdom The Royal Marsden Nhs Foundation Trust - Chelsea London
United Kingdom The Christie Nhs Foundation Trust Uk Manchester
United Kingdom James Cook University Hospital Middlesbrough
United Kingdom The Royal Marsden Nhs Foundation Trust - Sutton Sutton
United Kingdom The Royal Wolverhampton Nhs Trust Wolverhampton
United States University of Maryland-Greenebaum Cancer Center Baltimore Maryland
United States Cancer Center For Blood Disorders Bethesda Maryland
United States Roswell Park Cancer Institute Buffalo New York
United States Charleston Hematology Oncology Associates Charleston South Carolina
United States Levine Cancer Institute Charlotte North Carolina
United States University of Virginia Medical Center Charlottesville Virginia
United States John Muir Health Clinical Research Center Concord California
United States Texas Oncology-Baylor Charles A. Sammons Dallas Texas
United States Des Moines Oncology Research Association Des Moines Iowa
United States Barbara Ann Karmanos Cancer Hospital Detroit Michigan
United States The Center For Cancer and Blood Disorders Fort Worth Texas
United States Marin Cancer Care Greenbrae California
United States Prisma Health Upstate Greenville South Carolina
United States Hattiesburg Clinic Hematology Hattiesburg Mississippi
United States Straub Medical Center Honolulu Hawaii
United States Lyndon B Johnson General Hospital Houston Texas
United States Md Anderson Cancer Center Houston Texas
United States Cancer Specialists of North Florida Jacksonville Florida
United States Baptist Health Lexington Lexington Kentucky
United States Norton Cancer Institute Louisville Kentucky
United States Northwest Georgia Oncology Centers,P.C Marietta Georgia
United States Middlesex Hospital Cancer Center Middletown Connecticut
United States Smilow Cancer Hospital New Haven Connecticut
United States Tulane University New Orleans Louisiana
United States Nyu Clinical Cancer Center New York New York
United States Integris Cancer Institute Oklahoma City Oklahoma
United States Vista Oncology Inc Ps Olympia Washington
United States The Oncology Institute of Hope and Innovation Pasadena California
United States Brcr Medical Center, Inc Plantation Florida
United States Metro-Minnesota Community Oncology Reserch Consortium (Mmcorc) Saint Louis Park Minnesota
United States Utah Cancer Specialists Salt Lake City Utah
United States Sharp Memorial Hospital San Diego California
United States University of Washington-Seattle Cancer Care Alliance Seattle Washington
United States Virginia Mason Medical Center Seattle Washington
United States Renovatio Clinical Spring Texas
United States Northwest Medical Specialties Pllc Tacoma Washington
United States Prairie Lakes Health Care System, Inc. Watertown South Dakota
United States Asclepes Research Centers Weeki Wachee Florida

Sponsors (1)

Lead Sponsor Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Russian Federation,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary Overall Survival in FL Population Defined as survival from time of study randomization to death of any cause. Up to 6 years
Secondary 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
Secondary Overall Survival in overall Population Defined as survival from time of study initiation to death of any cause. Up to 6 years
Secondary 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
Secondary Duration of Response in FL and overall population Defined as the time to the first response to evidence of progression. Up to 6 years
Secondary Quality-of-Life Assessments in FL and overall populations Defined as a patient self evaluation questionnaire Up to 6 years
Secondary 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
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