Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)
Condition(s) studied
Investigational drug(s) / intervention(s)
Tafasitamab: Tafasitamab will be administered intravenously in 28-day cycles. During Cycles 1 through 3, tafasitamab will be administered weekly on Days 1, 8, 15, and 22; an additional loading dose will be administered on Cycle 1 Day 4. Starting with Cycle 4, tafasitamab will be administered on Days 1 and 15 of each cycle.
Lenalidomide: Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.
Study summary
The purpose of this study is to assess the efficacy and safety of of tafasitamab plus lenalidomide in adults with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory to at least 1 but no more than 3 previous systemic DLBCL treatment regimens and who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT).
Eligibility
Primary outcome measure(s)
- Overall Response Rate (ORR) — Approximately 24 months
Percentage of participants having best response of Complete Response (CR) or Partial Response (PR) as per Independent Review Committee and investigator's assessment.
Trial sites (61)
| Facility | City | Region | Status |
|---|---|---|---|
| Medical University Plovdiv | Plovdiv | Bulgaria | |
| Acibadem Cityclinica Mhat Tokuda | Sofia | Bulgaria | |
| Umhat Alexandrovska Sofia | Sofia | Bulgaria | |
| Umhat Sv. Ivan Rilski Ead | Sofia | Bulgaria | |
| Specialized Hospital For Active Treatment of Oncological Diseases - Sofia District Eood | Sofia | Bulgaria | |
| Clinical Hospital Dubrava | Zagreb | Croatia | |
| Clinical Hospital Merkur | Zagreb | Croatia | |
| University Hospital Centre Zagreb | Zagreb | Croatia | |
| Fakultni Nemocnice Olomouc | Olomouc | Czechia | |
| Vseobecna Fakultni Nemocnice | Prague | Czechia | |
| Aarhus University Hospital | Aarhus | Denmark | |
| Odense University Hospital | Odense | Denmark | |
| Helsinki University Central Hospital | Helsinki | Finland | |
| Kuopio University Hospital | Kuopio | Finland | |
| Oulu University Hospital | Oulu | Finland | |
| Tampere University Hospital | Tampere | Finland | |
| Turku University Hospital | Turku | Finland | |
| Semmelweis Egyetem | Budapest | Hungary | |
| National Institute of Oncology | Budapest | Hungary | |
| University of Debrecen | Debrecen | Hungary | |
| Markhot Ferenc Korhaz | Eger | Hungary | |
| Somogy Medyei Kaposi Mor Oktato Korhaz | Kaposvár | Hungary | |
| Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza | Szeged | Hungary | |
| Bon Secours Hospital | Cork | Ireland | |
| Mater Misericordiae University Hospital | Dublin | Ireland | |
| University Hospital Galway | Galway | Ireland | |
| Rambam Health Care Campus | Haifa | Israel | |
| Shaare Zedek Mc | Jerusalem | Israel | |
| Hadassah University Hospital | Jerusalem | Israel | |
| Meir Medical Center | Kefar Sava | Israel | |
| Akershus University Hospital | Lorenskog | Norway | |
| Universitetssykehuset I Trondheim - St. Olavs Hospital | Trondheim | Norway | |
| Szpital Uniwersytecki Nr 2 Im Dr. Jana Biziela | Bydgoszcz | Poland | |
| Medical University of Gdansk | Gdansk | Poland | |
| Szpital Morski Im. Pck Sp. Z O.O | Gdynia | Poland | |
| University Public Hospital Nr 1 | Lublin | Poland | |
| Oddzia Kliniczny Hematologii | Olsztyn | Poland | |
| Pratia Poznan | Skórzewo | Poland | |
| Maria Sklodowska-Curie National Research Institute of Oncology | Warsaw | Poland | |
| Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego | Wroclaw | Poland |
+ 21 more sites — see the full list on the official registry below.
On this site
📄 Revlimid (lenalidomide) drug profile →More Incyte Corporation trials in the UK
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 NCT05429268 on ClinicalTrials.gov ↗ ← All trials in the UK