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ACTIVE NOT RECRUITING
NCT05222555
PHASE1/PHASE2

Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients

Sponsor: Incyte Corporation

View on ClinicalTrials.gov

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

Interventions

DRUG

Tafasitamab

tafasitamab will be administered intravenously at protocol defined timepoints

DRUG

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