NCT04680052Active, not recruitingPhase 3
A Phase 3 study of Tafasitamab plus Lenalidomide in addition to Rituximab, versus Lenalidomide plus Rituximab in patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Aug 2026
Brief summary (registry, in English)
To compare the efficacy of tafasitamab and lenalidomide in addition to rituximab to the efficacy of placebo and lenalidomide in addition to rituximab in participants with relapsed/ refractory (R/R) FL.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 345 (estimated)
- First submitted
- 16 Nov 2023
- Start date
- 5 Jun 2021
- Lead sponsor
- Incyte Corp.
- Diseases
- Follicular lymphoma
- EU CT number
- 2023-504684-16-00
- EudraCT number
- 2020-004407-13
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 345
- 116 sites in 16 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Women who are pregnant or breastfeeding. 2. History of or current histology other than FL and MZL or clinical evidence of transformed lymphoma by investigator (INV) assessment. 3. History of radiation therapy to ≥ 25% of the BM for other diseases. 4. Active systemic infection. 5. Participants in a severely immunocompromised state. 6. Known CNS lymphoma involvement. Please refer to section 5.2 of the protocol for the full list of exclusion criteria.
Who the study is looking for
- Male and female participants at least 18 years of age who have a histologically confirmed Grade 1, 2 or 3a FL or histologically confirmed nodal MZL, splenic MZL, or extranodal MZL 2. Must have been previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy. This includes treatments such as rituximab monotherapy or chemotherapy plus immunotherapy with rituximab or obinutuzumab, with or without maintenance. 3. Must have documented relapsed, refractory, or progressive disease (PD) after treatment with systemic therapy a. Relapsed lymphoma: relapsed after initial response of CR or PR ≥ 6 months after prior therapy. b. Refractory lymphoma: achieved less than PR to the last treatment or achieved a CR or PR that lasted less than 6 months. c. Progressive lymphoma: PD after initial response of SD to prior therapy. Please refer to section 5.1 of the protocol for the full list of inclusion criteria.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (116)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Active, not recruiting |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Active, not recruiting |
| Kepler Universitaetsklinikum GmbH Coordinator of this site? Confirm its status | Linz | Austria | Active, not recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Active, not recruiting |
| Hanusch Krankenhaus der Wiener Gebietskrankenkasse Coordinator of this site? Confirm its status | Vienna | Austria | Active, not recruiting |
| Het Ziekenhuisnetwerk Antwerpen Coordinator of this site? Confirm its status | Antwerp | Belgium | Active, not recruiting |
| Az St-Jan Brugge-Oostende A.V. Coordinator of this site? Confirm its status | Brugge | Belgium | Active, not recruiting |
| Institut Jules Bordet Coordinator of this site? Confirm its status | Brussels | Belgium | Active, not recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| CHU de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Active, not recruiting |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Active, not recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Active, not recruiting |
| UCL Mont-Godinne Coordinator of this site? Confirm its status | Yvoir | Belgium | Active, not recruiting |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Active, not recruiting |
| Fakultni Nemocnice Ostrava Coordinator of this site? Confirm its status | Poruba | Czechia | Active, not recruiting |
| Fakultní Nemocnice Královské Vinohrady Coordinator of this site? Confirm its status | Prague 10 | Czechia | Active, not recruiting |
| Vseobecna Fakultni Nemocnice V Praze Coordinator of this site? Confirm its status | Prague 2 | Czechia | Active, not recruiting |
| Vivantes Netzwerk fuer Gesundheit GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Active, not recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Active, not recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Active, not recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Active, not recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario De Burgos Coordinator of this site? Confirm its status | Burgos | Spain | Active, not recruiting |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia | Spain | Active, not recruiting |
| Hospital Universitario de Cabueñes Coordinator of this site? Confirm its status | Gijón | Spain | Active, not recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Active, not recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Active, not recruiting |
| Hospital Son Llatzer Coordinator of this site? Confirm its status | Palma | Spain | Active, not recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Active, not recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Fundacio Assistencial De Mutua De Terrassa Fpc Coordinator of this site? Confirm its status | Terrassa | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Universitario Dr. Peset Aleixandre Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Universitario Araba Coordinator of this site? Confirm its status | Vitoria | Spain | Active, not recruiting |
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Active, not recruiting |
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Active, not recruiting |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Active, not recruiting |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Active, not recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Active, not recruiting |
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Active, not recruiting |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Active, not recruiting |
| Centre Hospitalier De Versailles Coordinator of this site? Confirm its status | Le Chesnay Rocquencourt | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Hopital Universitaire Pitie Salpetriere Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Active, not recruiting |
| Hôpital NOVO Coordinator of this site? Confirm its status | Pontoise | France | Active, not recruiting |
| Centre Hospitalier Annecy Genevois Coordinator of this site? Confirm its status | Pringy Cedex | France | Active, not recruiting |
| Centre Hospitalier Yves Le Foll Coordinator of this site? Confirm its status | Saint-Brieuc | France | Active, not recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Active, not recruiting |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| 251 Air Force General Hospital Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Coordinator of this site? Confirm its status | Chaïdári | Greece | Active, not recruiting |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Active, not recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Active, not recruiting |
| Orszagos Onkologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Active, not recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Active, not recruiting |
| Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet Coordinator of this site? Confirm its status | Eger | Hungary | Active, not recruiting |
| Somogy Vármegyei Kaposi Mór Oktató Kórház Coordinator of this site? Confirm its status | Kaposvár | Hungary | Active, not recruiting |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Active, not recruiting |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Active, not recruiting |
| Mater Misericordiae University Hospital Coordinator of this site? Confirm its status | Dublin 7 | Ireland | Active, not recruiting |
| Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria Coordinator of this site? Confirm its status | Alexandria | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Active, not recruiting |
| Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Coordinator of this site? Confirm its status | Candiolo | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Active, not recruiting |
| Ospedale Vito Fazzi Lecce Coordinator of this site? Confirm its status | Lecce | Italy | Active, not recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Active, not recruiting |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Active, not recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Active, not recruiting |
| Hospital Santa Maria Della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Active, not recruiting |
| Azienda Unita Sanitaria Locale Di Piacenza Coordinator of this site? Confirm its status | Piacenza | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Active, not recruiting |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Active, not recruiting |
| Azienda USL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Active, not recruiting |
| Azienda Unita Sanitaria Locale Della Romagna Coordinator of this site? Confirm its status | Rimini | Italy | Active, not recruiting |
| Ospedale S. Eugenio Coordinator of this site? Confirm its status | Roma | Italy | Active, not recruiting |
| Azienda Ospedaliera S Maria Di Terni Coordinator of this site? Confirm its status | Terni | Italy | Active, not recruiting |
| Azienda Sanitaria Universitaria Giuliano Isontina Coordinator of this site? Confirm its status | Trieste | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| Rijnstate Ziekenhuis Stichting Coordinator of this site? Confirm its status | Arnhem | Netherlands | Active, not recruiting |
| Medisch Centrum Leeuwarden B.V. Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Active, not recruiting |
| Medical Center Haaglanden Coordinator of this site? Confirm its status | Leidschendam | Netherlands | Active, not recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Active, not recruiting |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Active, not recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie Coordinator of this site? Confirm its status | Krakow | Poland | Active, not recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Aidport sp z o.o. Coordinator of this site? Confirm its status | Skorzewo | Poland | Active, not recruiting |
| Instytut Hematologii I Transfuzjologii Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Active, not recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Active, not recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.