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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.
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (116)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz
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GrazAustriaActive, not recruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaActive, not recruiting
Kepler Universitaetsklinikum GmbH
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LinzAustriaActive, not recruiting
Medical University of Vienna
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ViennaAustriaActive, not recruiting
Hanusch Krankenhaus der Wiener Gebietskrankenkasse
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ViennaAustriaActive, not recruiting
Het Ziekenhuisnetwerk Antwerpen
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AntwerpBelgiumActive, not recruiting
Az St-Jan Brugge-Oostende A.V.
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BruggeBelgiumActive, not recruiting
Institut Jules Bordet
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BrusselsBelgiumActive, not recruiting
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
CHU de Liège
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LiègeBelgiumActive, not recruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumActive, not recruiting
UCL Mont-Godinne
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YvoirBelgiumActive, not recruiting
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaActive, not recruiting
Fakultni Nemocnice Ostrava
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PorubaCzechiaActive, not recruiting
Fakultní Nemocnice Královské Vinohrady
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Prague 10CzechiaActive, not recruiting
Vseobecna Fakultni Nemocnice V Praze
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Prague 2CzechiaActive, not recruiting
Vivantes Netzwerk fuer Gesundheit GmbH
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BerlinGermanyActive, not recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
Universitaet Muenster
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MuensterGermanyActive, not recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyActive, not recruiting
Aalborg University Hospital
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AalborgDenmarkActive, not recruiting
Hospital General Universitario Dr. Balmis
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AlicanteSpainActive, not recruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital del Mar
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BarcelonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Universitario De Burgos
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BurgosSpainActive, not recruiting
Hospital Universitario Donostia
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DonostiaSpainActive, not recruiting
Hospital Universitario de Cabueñes
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GijónSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainActive, not recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainActive, not recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainActive, not recruiting
Hospital Son Llatzer
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PalmaSpainActive, not recruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Fundacio Assistencial De Mutua De Terrassa Fpc
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TerrassaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Hospital Universitario Dr. Peset Aleixandre
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ValenciaSpainActive, not recruiting
Hospital Universitario Araba
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VitoriaSpainActive, not recruiting
HUS-Yhtymae
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HelsinkiFinlandActive, not recruiting
Kuopio University Hospital
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KuopioFinlandActive, not recruiting
Oulu University Hospital
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OuluFinlandActive, not recruiting
Tampere University Hospital
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TampereFinlandActive, not recruiting
Turku University Hospital
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TurkuFinlandActive, not recruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceActive, not recruiting
Centre Hospitalier Universitaire D'Angers
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AngersFranceActive, not recruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceActive, not recruiting
Centre Hospitalier De Versailles
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Le Chesnay RocquencourtFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Hopital Saint Louis
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ParisFranceActive, not recruiting
Hopital Universitaire Pitie Salpetriere
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Paris Cedex 13FranceActive, not recruiting
Hôpital NOVO
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PontoiseFranceActive, not recruiting
Centre Hospitalier Annecy Genevois
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Pringy CedexFranceActive, not recruiting
Centre Hospitalier Yves Le Foll
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Saint-BrieucFranceActive, not recruiting
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceActive, not recruiting
Laiko General Hospital of Athens
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AthensGreeceActive, not recruiting
251 Air Force General Hospital
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AthensGreeceActive, not recruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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ChaïdáriGreeceActive, not recruiting
General University Hospital Of Patras
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PatrasGreeceActive, not recruiting
Semmelweis University
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Budapest VIIIHungaryActive, not recruiting
Orszagos Onkologiai Intezet
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Budapest XIIHungaryActive, not recruiting
University of Debrecen
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DebrecenHungaryActive, not recruiting
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
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EgerHungaryActive, not recruiting
Somogy Vármegyei Kaposi Mór Oktató Kórház
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KaposvárHungaryActive, not recruiting
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
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NyíregyházaHungaryActive, not recruiting
University of Szeged
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SzegedHungaryActive, not recruiting
Mater Misericordiae University Hospital
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Dublin 7IrelandActive, not recruiting
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
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AlexandriaItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyActive, not recruiting
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
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CandioloItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyActive, not recruiting
Ospedale Vito Fazzi Lecce
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LecceItalyActive, not recruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyActive, not recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyActive, not recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyActive, not recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
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NovaraItalyActive, not recruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyActive, not recruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
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PalermoItalyActive, not recruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyActive, not recruiting
Hospital Santa Maria Della Misericordia
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PerugiaItalyActive, not recruiting
Azienda Unita Sanitaria Locale Di Piacenza
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PiacenzaItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyActive, not recruiting
Azienda USL IRCCS di Reggio Emilia
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Reggio EmiliaItalyActive, not recruiting
Azienda Unita Sanitaria Locale Della Romagna
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RiminiItalyActive, not recruiting
Ospedale S. Eugenio
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RomaItalyActive, not recruiting
Azienda Ospedaliera S Maria Di Terni
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TerniItalyActive, not recruiting
Azienda Sanitaria Universitaria Giuliano Isontina
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TriesteItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
Amsterdam UMC
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AmsterdamNetherlandsActive, not recruiting
Rijnstate Ziekenhuis Stichting
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ArnhemNetherlandsActive, not recruiting
Medisch Centrum Leeuwarden B.V.
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LeeuwardenNetherlandsActive, not recruiting
Medical Center Haaglanden
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LeidschendamNetherlandsActive, not recruiting
Oslo University Hospital HF
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OsloNorwayActive, not recruiting
St. Olavs hospital HF
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TrondheimNorwayActive, not recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
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KrakowPolandActive, not recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
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LublinPolandActive, not recruiting
Pratia S.A.
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PoznanPolandActive, not recruiting
Aidport sp z o.o.
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SkorzewoPolandActive, not recruiting
Instytut Hematologii I Transfuzjologii
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WarsawPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandActive, not recruiting
Karolinska University Hospital
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SolnaSwedenActive, not recruiting
Uppsala University Hospital
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UppsalaSwedenActive, not recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.