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Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients
Sponsor: Incyte Corporation
Summary
This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.
Official title: A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
53
Start Date
2022-07-19
Completion Date
2027-11-30
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
Tafasitamab
tafasitamab will be administered intravenously at protocol defined timepoints
Lenalidomide
lenalidomide will be administered orally at protocol defined timepoints
Locations (62)
Morristown Memorial Hospital
Morristown, New Jersey, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR
Dallas, Texas, United States
Vista Oncology
Olympia, Washington, United States
UK St. Pölten
Sankt Pölten, Lower Austria, Austria
Klinikum Wels Grieskirchen
Wels, Upper Austria, Austria
Universitatsklinikum Salzburg
Salzburg, Austria
Fakultni nemocnice Brno
Brno, Czechia
Fakultni nemocnice Ostrava
Ostrava, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia
Fakultni nemocnice v Motole
Prague, Czechia
Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon
Grenoble, Isère, France
CHU Nantes
Nantes, Loire-Atlantique, France
Centre Hospitalier Le Mans
Le Mans, Sarthe, France
CHU de Poitiers
Poitiers, Vienne, France
Soroka University Medical Centre
Beersheba, Southern District, Israel
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, Israel
Lady Davis Carmel Medical Center
Haifa, Israel
Hadassah Medical Center - Hadassah Ein Kerem
Jerusalem, Israel
ZIV Medical Center
Safed, Israel
Ospedale Santa Maria Delle Croci
Ravenna, Emilia-Romagna, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
Milan, Lombardy, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, Italy
ASST di Monza - Azienda Ospedaliera San Gerardo
Monza, Monza E Brianza, Italy
Fondazione del Piemonte per l'Oncologia (IRCCS)
Candiolo, Piedmont, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Azienda Ospedaliera di Perugia
Perugia, Umbria, Italy
Centrum Medyczne Poznan - PRATIA - PPDS
Skórzewo, Greater Poland Voivodeship, Poland
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
Wroclaw, Lower Silesian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, Poland
Szpital Wojewodzki w Opolu
Opole, Opole Voivodeship, Poland
Szpitale Pomorskie Sp. z o. o.
Gdynia, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, Poland
SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Poland
Nasz Lekarz Osrodek Badan Klinicznych
Torun, Poland
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggido, South Korea
Dong-A University Medical Center
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Kosin University Gospel Hospital
Busan, South Korea
Yeungnam University Hospital
Daegu, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Hanyang University Medical Center
Seoul, South Korea
Asan Medical Center - PPDS
Seoul, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
Institut Catala d'Oncologia Girona
Girona, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain
Hospital U. Infanta Leonor
Madrid, Spain
MD Anderson Madrid
Madrid, Spain
Hospital U. Ramon y Cajal
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital U. Quironsalud Madrid
Madrid, Spain
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, Spain
Hospital U. Virgen del Rocio
Seville, Spain
Hospital Universitari La Fe
Valencia, Spain