Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
Tafasitamab: tafasitamab will be administered intravenously at protocol defined timepoints
Lenalidomide: lenalidomide will be administered orally at protocol defined timepoints
Study 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.
Eligibility
Primary outcome measure(s)
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE) — up to approximately 2 years
An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Therefore, an AE could be any unfavorable or unintended sign (including an abnormal laboratory finding) or symptom temporally associated with the use of study treatment. A TEAE was defined as any AE that started or worsened after the first dose of study treatment until 90 days after the last dose of the study treatment. An AE that was present prior to study drug administration but increased in severity after treatment start was also included as a TEAE. - Number of Participants With Any ≥Grade 3 TEAE — up to approximately 2 years
The toxicity grade of TEAEs was graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) using the following definitions: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal; local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.). Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE.
Trial sites (62)
| Facility | City | Region | Status |
|---|---|---|---|
| Morristown Memorial Hospital | Morristown | New Jersey | |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR | Dallas | Texas | |
| Vista Oncology | Olympia | Washington | |
| UK St. Pölten | Sankt Pölten | Lower Austria | |
| Klinikum Wels Grieskirchen | Wels | Upper 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 | |
| CHU Nantes | Nantes | Loire-Atlantique | |
| Centre Hospitalier Le Mans | Le Mans | Sarthe | |
| CHU de Poitiers | Poitiers | Vienne | |
| Soroka University Medical Centre | Beersheba | Southern District | |
| 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 | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Lombardy | |
| ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda | Milan | Lombardy | |
| Fondazione IRCCS Policlinico San Matteo di Pavia | Pavia | Lombardy | |
| ASST di Monza - Azienda Ospedaliera San Gerardo | Monza | Monza E Brianza | |
| Fondazione del Piemonte per l'Oncologia (IRCCS) | Candiolo | Piedmont | |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Tuscany | |
| Azienda Ospedaliera di Perugia | Perugia | Umbria | |
| Centrum Medyczne Poznan - PRATIA - PPDS | Skórzewo | Greater Poland Voivodeship | |
| Pratia MCM Krakow | Krakow | Lesser Poland Voivodeship | |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | Lower Silesian Voivodeship | |
| Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii | Wroclaw | Lower Silesian Voivodeship | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy | Warsaw | Masovian Voivodeship | |
| Szpital Wojewodzki w Opolu | Opole | Opole Voivodeship | |
| 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 |
+ 22 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05222555 on ClinicalTrials.gov ↗ ← All trials in France