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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.
Sponsor: Incyte Corporation
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
654
Start Date
2021-04-15
Completion Date
2028-08-09
Last Updated
2026-09-04
Healthy Volunteers
No
Interventions
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 (261)
John Muir Health Clinical Research Center
Concord, California, United States
Marin Cancer Care
Greenbrae, California, United States
The Oncology Institute of Hope and Innovation
Pasadena, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Middlesex Hospital Cancer Center
Middletown, Connecticut, United States
Smilow Cancer Hospital
New Haven, Connecticut, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Brcr Medical Center, Inc
Plantation, Florida, United States
Asclepes Research Centers
Weeki Wachee, Florida, United States
Northwest Georgia Oncology Centers,P.C
Marietta, Georgia, United States
Straub Medical Center
Honolulu, Hawaii, United States
Des Moines Oncology Research Association
Des Moines, Iowa, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Tulane University
New Orleans, Louisiana, United States
University of Maryland-Greenebaum Cancer Center
Baltimore, Maryland, United States
Cancer Center For Blood Disorders
Bethesda, Maryland, United States
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan, United States
Metro-Minnesota Community Oncology Reserch Consortium (Mmcorc)
Saint Louis Park, Minnesota, United States
Hattiesburg Clinic Hematology
Hattiesburg, Mississippi, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Nyu Clinical Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Integris Cancer Institute
Oklahoma City, Oklahoma, United States
Charleston Hematology Oncology Associates
Charleston, South Carolina, United States
Prisma Health Upstate
Greenville, South Carolina, United States
Prairie Lakes Health Care System, Inc.
Watertown, South Dakota, United States
Texas Oncology-Baylor Charles A. Sammons
Dallas, Texas, United States
The Center For Cancer and Blood Disorders
Fort Worth, Texas, United States
Lyndon B Johnson General Hospital
Houston, Texas, United States
Md Anderson Cancer Center
Houston, Texas, United States
Renovatio Clinical
Spring, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Vista Oncology Inc Ps
Olympia, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
University of Washington-Seattle Cancer Care Alliance
Seattle, Washington, United States
Northwest Medical Specialties Pllc
Tacoma, Washington, United States
St George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Sydney, New South Wales, Australia
Wollongong Hospital - Illawarra Regional Hospital
Wollongong, New South Wales, Australia
Gold Coast Hospital
Southport, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Northern Hospital
Melbourne, Victoria, Australia
Western Health
St Albans, Victoria, Australia
Perth Blood Institute
West Perth, Western Australia, Australia
Eastern Health
Box Hill, Australia
Royal Hobart Hospital
Hobart, Australia
Landeskrankenhaus Universitatsklinikum Graz
Graz, Austria
Innsbruck University Hospital
Innsbruck, Austria
Kepler Universitat Klinikum
Linz, Austria
*Krankenhaus*
Vienna, Austria
Zna Stuivenberg
Antwerp, Belgium
A.Z. St.-Jan-Dienst Hematologie
Bruges, Belgium
Institut Jules Bordet
Brussels, Belgium
Cliniques Universitaires Ucl Saint-Luc
Brussels, Belgium
Universitair Ziekenhuis Antwerpen, Dienst Hematologie
Edegem, Belgium
Ghent University Hospital
Ghent, Belgium
Universitair Ziekenhuis (Uz) Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, Belgium
AZ Delta
Roeselare, Belgium
Chu Ucl Namur University Hospital Mont-Godinne
Yvoir, Belgium
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Queen Elizabeth Ii Health Sciences Centre
Halifax, Nova Scotia, Canada
London Health Sciences Centre
London, Ontario, Canada
Hospital Maisonneuve Rosemont
Montreal, Quebec, Canada
McGill University Jewish General Hospital
Montreal, Quebec, Canada
Chu de Quebec - Universite Laval (Chul)
Québec, Quebec, Canada
University
Brno, Czechia
University Hospital Hradec Kralove
Hradec Králové, Czechia
University Hospital Ostrava
Ostrava, Czechia
University Hospital Kralovkse Vinohrady
Prague, Czechia
Vseobecna Fakultni Nemocnice
Prague, Czechia
University Hospital Motol
Prague, Czechia
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Odense University Hospital
Odense, Denmark
Sjaellands Universitetshospital Naestved
Roskilde, Denmark
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Chu Amiens Picardie - Hopital Sud
Amiens, France
Chu Angers Hotel Dieu Nord
Angers, France
Groupe Bordeaux Nord Aquitaine Gbna Polycliniques - Polyclinique Bordeaux Nord Aquitaine Pbna
Bordeaux, France
Centre Hospitalier Universitaire Chu Dijon Bourgogne - Hopital Francois Mitterrand
Dijon, France
Centre Hospitalier de Versailles - Hopital Andre Mignot
Le Chesnay, France
CHU Nantes
Nantes, France
Hospital Saint-Louis Service Oncologie Medicale
Paris, France
A.P.H. Paris Hopital Cochin
Paris, France
Hôpital Pitié Salpêtrière
Paris, France
Centre Hospitalier de Pontoise
Pontoise, France
Centre Hospitalier Annecy-Genevois
Pringy, France
Chru Hopitaux de Tours Hospital Bretonneau
Tours, France
Klinikum St. Marien Amberg
Amberg, Germany
Klinik Fur Innere Medizin Hamatologie and Onkologie
Berlin, Germany
Universitatsklinikum Essen
Essen, Germany