Brief Summary

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

Conditions

• Diffuse Large B-cell Lymphoma

Intervention / Treatment

• Drug: Tafasitamab
• Drug: Lenalidomide
• Drug: Rituximab
• Drug: Rituximab
• Drug: Cyclophosphamide
• Drug: Cyclophosphamide
• Drug: Doxorubicin
• Drug: Doxorubicin
• Drug: Vincristine
• Drug: Vincristine
• Drug: Prednisone
• Drug: Prednisone
• Drug: Tafasitamab placebo
• Drug: Lenalidomide placebo

Primary Outcome Measures

• PFS-INV (Time from date of randomization until Progressive Disease or death from any cause. In this trial, the primary endpoint is PFS as assessed by the investigator (up to 43 months))
  Progression-Free Survival as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma

Countries

Argentina, Australia, Austria, Canada, Colombia, Czechia, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Malaysia, New Zealand, Philippines, Poland, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States

Locations and Investigators

• Centre Hospitalier De Versailles, Le Chesnay-Rocquencourt, France
  • Caroline, Besson
• Centre Hospitalier Le Mans, Le Mans Cedex 9, France
  • Kamel, Laribi
• Centre Hospitalier Universitaire De Poitiers, Poitiers, France
  • Stephanie, Guidez
• Institut Bergonie, Bordeaux, France
  • Fontanet, Bijou
• Groupement Des Hopitaux De L'Institut Catholique De Lille, Lille Cedex, France
  • Sandy, Amorim
• CHRU De Nancy, Vandoeuvre Les Nancy, France
  • Pierre, Feugier
• Centre Hospitalier Universitaire De Caen Normandie, Caen Cedex 9, France
  • Gandhi Laurent, Damaj
• Centre Hospitalier Universitaire De Saint Etienne, Saint Priest En Jarez, France
  • Ludovic, Fouillet
• Centre Hospitalier Bretagne Atlantique, Vannes, France
  • Brieuc, Cherel
• Centre Hospitalier Universitaire De Bordeaux, Pessac, France
  • Kamal-Krimo, Bouabdallah
• Centre Hospitalier Universitaire De Nantes, Nantes, France
  • Thomas, Gastinne
• Centre Hospitalier Intercommunal De Cornouaille, Quimper Cedex, France
  • Ronan, Le Calloch
• Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Cedex 9, France
  • Lysiane, Molina
• St Vincent's University Hospital, Dublin 4, Ireland
  • Liam, Smyth
• Hanusch Krankenhaus Der Wiener Gebietskrankenkasse, Vienna, Austria
  • Michael, Panny
• Noe LGA Gesundheit Region Mitte GmbH, St. Poelten, Austria
  • Petra, Pichler-Izmir
• Vorarlberger Krankenhaus-Betriebsgesellschaft mbH, Feldkirch, Austria
  • Bernd, Hartmann
• Medizinische Universitaet Innsbruck, Innsbruck, Austria
  • Wolfgang, Willenbacher
• Medical University Of Vienna, Vienna, Austria
  • Philipp, Staber
• Ordensklinikum Linz GmbH, Linz, Austria
  • Manuel, Orlinger
• Kepler Universitaetsklinikum GmbH, Linz, Austria
  • Clemens, Schmitt
• Onco Card S.R.L., Brasov, Romania
  • Mihaela Cornelia, Lazaroiu
• Spitalul Clinic Municipal Filantropia Craiova, Craiova, Romania
  • Luminita, Ocroteala
• Spitalul Universitar De Urgenta Bucuresti, Bucharest, Romania
  • Horia, Bumbea
• Institutul Clinic Fundeni, Bucharest, Romania
  • Daniel, Coriu
• Institutul Regional De Oncologie Iasi, Iasi, Romania
  • Catalin Doru, Danaila
• Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca, Cluj-Napoca, Romania
  • Delia Monica, Dima
• Orszagos Onkologiai Intezet, Budapest XII, Hungary
  • Tamas, Schneider
• University Of Debrecen, Debrecen, Hungary
  • Arpad, Illes
• Semmelweis University, Budapest VIII, Hungary
  • Zsolt, Nagy
• Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz, Gyor, Hungary
  • Eszter, Sari
• Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz, Nyiregyhaza, Hungary
  • Laszlo, Rejto
• Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi, Lodz, Poland
  • Magdalena, Witkowska
• Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, Warsaw, Poland
  • Anna, Dąbrowska-Iwanicka
• Univerzitna nemocnica L. Pasteura Kosice, Kosice - Zapad, Slovakia
  • Tomáš, Guman
• National Oncology Institute, Bratislava, Slovakia
  • Ľuboš, Drgoňa
• Azienda Ospedale-Universita Padova, Padova, Italy
  • Francesco, Piazza
• Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
  • Luca, Arcaini
• IRCCS Ospedale Policlinico San Martino, Genoa, Italy
  • Roberto Massimo, Lemoli
• Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano, Italy
  • Alessandro, Morotti
• Azienda Unita Sanitaria Locale Della Romagna, Rimini, Italy
  • Anna, Merli
• Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria, Alexandria, Italy
  • Manuela, Zanni
• European Institute Of Oncology S.r.l., Milan, Italy
  • Enrico, Derenzini
• Azienda Unita Sanitaria Locale Della Romagna, Ravenna, Italy
  • Monica, Tani
• Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania, Catania, Italy
  • Francesco, Di Raimondo
• Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Palermo, Italy
  • Caterina, Patti
• Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS, Candiolo, Italy
  • Umberto, Vitolo
• Ospedale Vito Fazzi Lecce, Lecce, Italy
  • Nicola, Di Renzo
• Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., Meldola, Italy
  • Gerardo, Musuraca
• Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy
  • Silvia, Ferrari

And 54 other sites.

Study Officials

• Incyte Medical Director (Study Director) — Incyte Corporation