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NCT06549595RecruitingPhase 3

A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

A Phase III, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 Plus Rituximab Versus Chemotherapy Plus Rituximab in Previously Untreated Participants With Follicular Lymphoma (SOUNDTRACK-F1)

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1018 (estimated)
First submitted
29 Jul 2024
Start date
7 Aug 2024
Primary completion date
26 Nov 2031
Lead sponsor
AstraZeneca
NCT number
NCT06549595
EU CT number
2023-510098-33-01

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1018
  • From 7 Aug 2024 to the primary completion date, 26 Nov 2031
  • 217 sites in 25 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Active or uncontrolled infection (including EBV) requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study. If a participant has a history of COVID-19 within 1 month of C1D1 or contracts COVID while on study treatment, participant must have 2 consecutive negative tests (PCR testing is preferable) performed at least 48 hours apart prior to resuming dosing. All symptoms related to COVID-19 infection should have fully resolved before initiating or resuming treatment

Other illness

  • Participants with or history of CNS lymphoma
  • History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic or that which the treating investigator considers to have the potential to interfere with the evaluation of safety
  • Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)
    • The above is a summary, other exclusion criteria details may apply

Other

  • Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma
  • Contra-indication to BR, RCVP, and R-CHOP
  • Presence of \>5000 circulating lymphoma cells

Who the study is looking for

  • Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
  • Histologically confirmed diagnosis of classic FL per WHO 2022 classification
  • ECOG performance status of 0 to 2
  • No prior systemic lymphoma-directed therapy
  • Need for systemic treatment meeting at least 1 GELF criteria
  • FDG-avid and measurable disease
  • Stage II to IV and FLIPI 2-5 \[Phase III only\]
  • Adequate liver, hematological, renal and cardiac function.
    • The above is a summary, other inclusion criteria details may apply

Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (217)

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

SiteCityCountrySite status
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ClaytonAustraliaNot yet recruiting
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DarlinghurstAustraliaRecruiting
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GarranAustraliaRecruiting
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HeidelbergAustraliaRecruiting
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Macquarie UniversityAustraliaRecruiting
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NedlandsAustraliaRecruiting
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BrusselsBelgiumNot yet recruiting
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GhentBelgiumNot yet recruiting
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MechelenBelgiumNot yet recruiting
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Porto AlegreBrazilRecruiting
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São PauloBrazilRecruiting
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BarrieCanadaWithdrawn
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ChicoutimiCanadaRecruiting
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HalifaxCanadaRecruiting
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HamiltonCanadaRecruiting
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MontrealCanadaRecruiting
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OshawaCanadaRecruiting
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QuébecCanadaRecruiting
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Saint-JérômeCanadaRecruiting
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TorontoCanadaRecruiting
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WinnipegCanadaRecruiting
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BeijingChinaRecruiting
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ChangchunChinaRecruiting
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ChangshaChinaRecruiting
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ChengduChinaRecruiting
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ChongqingChinaRecruiting
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FuzhouChinaRecruiting
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GuangzhouChinaRecruiting
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HangzhouChinaRecruiting
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HarbinChinaRecruiting
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HefeiChinaRecruiting
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LanzhouChinaRecruiting
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NanchangChinaRecruiting
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NanjingChinaRecruiting
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NanningChinaRecruiting
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ShandongChinaRecruiting
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ShanghaiChinaRecruiting
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ShenyangChinaRecruiting
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ShijiazhuangChinaRecruiting
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SuzhouChinaRecruiting
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TianjinChinaRecruiting
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WenzhouChinaRecruiting
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WuhanChinaRecruiting
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XiamenChinaRecruiting
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Xi'anChinaRecruiting
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ZhengzhouChinaRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaNot yet recruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaNot yet recruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaNot yet recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyNot yet recruiting
Vivantes Netzwerk fuer Gesundheit GmbH
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BerlinGermanyNot yet recruiting
DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU
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DeggendorfGermanyNot yet recruiting
Marien Hospital Duesseldorf GmbH
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DuesseldorfGermanyNot yet recruiting
Universitaetsmedizin Goettingen
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GoettingenGermanyNot yet recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyNot yet recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyNot yet recruiting
Universitaetsklinikum Jena KöR
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JenaGermanyNot yet recruiting
Staedtisches Klinikum Karlsruhe gGmbH
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KarlsruheGermanyNot yet recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyNot yet recruiting
University Of Luebeck
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LuebeckGermanyNot yet recruiting
Otto Von Guericke Universitaet Magdeburg
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MagdeburgGermanyNot yet recruiting
Muehlenkreiskliniken AöR
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MindenGermanyNot yet recruiting
Universitaet Muenster
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MuensterGermanyNot yet recruiting
LMU Klinikum Muenchen AöR
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MunichGermanyNot yet recruiting
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
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RegensburgGermanyNot yet recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyNot yet recruiting
Region Nordjylland
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AalborgDenmarkNot yet recruiting
Rigshospitalet
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Copenhagen OeDenmarkNot yet recruiting
Odense University Hospital
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OdenseDenmarkNot yet recruiting
Region Sjaelland
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RoskildeDenmarkNot yet recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainNot yet recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainNot yet recruiting
Institut Català d'Oncologia
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GironaSpainNot yet recruiting
El Hospital Universitario De Gran Canaria Dr. Negrin
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Las Palmas De Gran CanariaSpainNot yet recruiting
Hospital Universitario 12 de Octubre
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MadridSpainNot yet recruiting
Hospital Universitario Central De Asturias
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OviedoSpainNot yet recruiting
Clínica Universidad de navarra
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PamplonaSpainNot yet recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainNot yet recruiting
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HelsinkiFinlandWithdrawn
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KuopioFinlandWithdrawn
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TampereFinlandWithdrawn
Centre Hospitalier de la Cote Basque
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BayonneFranceNot yet recruiting
Assistance Publique Hopitaux De Paris
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Creteil CedexFranceNot yet recruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceNot yet recruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceNot yet recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceNot yet recruiting
Centre Hospitalier Universitaire De Rennes
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Rennes Cedex 9FranceNot yet recruiting
Institut Curie
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Saint-CloudFranceNot yet recruiting
CHRU De Nancy
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Vandoeuvre Les NancyFranceNot yet recruiting
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LondonUnited KingdomRecruiting
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Newcastle upon TyneUnited KingdomRecruiting
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NorwichUnited KingdomRecruiting
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NottinghamUnited KingdomRecruiting
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PlymouthUnited KingdomRecruiting
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SouthamptonUnited KingdomWithdrawn
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Hong KongHong Kong SAR ChinaRecruiting
Semmelweis University
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Budapest VIIIHungaryNot yet recruiting
University of Debrecen
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DebrecenHungaryNot yet recruiting
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryNot yet recruiting
Somogy Vármegyei Kaposi Mór Oktató Kórház
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KaposvárHungaryNot yet recruiting
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
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NyíregyházaHungaryNot yet recruiting
University of Pecs
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PécsHungaryNot yet recruiting
University of Szeged
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SzegedHungaryNot yet recruiting
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DelhiIndiaNot yet recruiting
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GurugramIndiaNot yet recruiting
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KolkataIndiaRecruiting
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NashikIndiaRecruiting
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SuratIndiaRecruiting
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ThiruvananthapuramIndiaRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyRecruiting
Azienda USL IRCCS Di Reggio Emilia
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GuastallaItalyRecruiting
Istituto Europeo di Oncologia s.r.l
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MilanItalyRecruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyRecruiting
Azienda Sanitaria Universitaria Giuliano Isontina
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TriesteItalyRecruiting
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Bunkyō CityJapanRecruiting
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ChibaJapanRecruiting
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Chuo-shiJapanRecruiting
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FukuokaJapanRecruiting
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Hirakata-shiJapanRecruiting
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KobeJapanRecruiting
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KōtokuJapanRecruiting
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KumamotoJapanRecruiting
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Kurashiki-shiJapanRecruiting
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KyotoJapanRecruiting
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MinatokuJapanRecruiting
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OkayamaJapanRecruiting
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OsakaJapanRecruiting
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SapporoJapanRecruiting
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Sunto-gunJapanRecruiting
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Toyoake-shiJapanRecruiting
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YamagataJapanRecruiting
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YokohamaJapanRecruiting
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BusanSouth KoreaRecruiting
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Goyang-siSouth KoreaRecruiting
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JeonnamSouth KoreaRecruiting
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SeoulSouth KoreaRecruiting
Pratia S.A.
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CracowPolandNot yet recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandNot yet recruiting
Pratia Hematologia Sp. Z o. o
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KatowicePolandNot yet recruiting
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
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LublinPolandNot yet recruiting
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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LublinPolandNot yet recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandNot yet recruiting
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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WroclawPolandNot yet recruiting
Pratia S.A.
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WroclawPolandNot yet recruiting
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San JuanPuerto RicoRecruiting
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FalunSwedenWithdrawn
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UppsalaSwedenWithdrawn
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BangkokThailandRecruiting
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Chiang MaiThailandRecruiting
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Khon KaenThailandRecruiting
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ChanghuaTaiwanRecruiting
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Kaohsiung CityTaiwanRecruiting
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Lukang TownshipTaiwanRecruiting
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TainanTaiwanRecruiting
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TaipeiTaiwanRecruiting
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AlbanyUnited StatesRecruiting
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AnchorageUnited StatesRecruiting
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Ann ArborUnited StatesNot yet recruiting
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AtlantaUnited StatesNot yet recruiting
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AuroraUnited StatesWithdrawn
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AustinUnited StatesNot yet recruiting
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BaltimoreUnited StatesNot yet recruiting
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Baton RougeUnited StatesNot yet recruiting
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BethesdaUnited StatesRecruiting
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Blue AshUnited StatesNot yet recruiting
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BostonUnited StatesNot yet recruiting
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BrooklynUnited StatesNot yet recruiting
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CharlotteUnited StatesNot yet recruiting
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ChesterfieldUnited StatesNot yet recruiting
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CincinnatiUnited StatesNot yet recruiting
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ClovisUnited StatesNot yet recruiting
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ColumbiaUnited StatesNot yet recruiting
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ColumbusUnited StatesNot yet recruiting
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Des MoinesUnited StatesNot yet recruiting
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DetroitUnited StatesWithdrawn
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EugeneUnited StatesNot yet recruiting
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EvanstonUnited StatesNot yet recruiting
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FairfaxUnited StatesNot yet recruiting
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Fort WayneUnited StatesRecruiting
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HackensackUnited StatesNot yet recruiting
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HuntsvilleUnited StatesRecruiting
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Iowa CityUnited StatesNot yet recruiting
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JacksonvilleUnited StatesRecruiting
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LexingtonUnited StatesNot yet recruiting
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Los AlamitosUnited StatesRecruiting
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LouisvilleUnited StatesNot yet recruiting
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LubbockUnited StatesNot yet recruiting
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MaconUnited StatesRecruiting
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MadisonUnited StatesNot yet recruiting
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MilwaukeeUnited StatesNot yet recruiting
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MineolaUnited StatesNot yet recruiting
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NashvilleUnited StatesRecruiting
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NewarkUnited StatesNot yet recruiting
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New BrunswickUnited StatesNot yet recruiting
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New HavenUnited StatesRecruiting
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New Hyde ParkUnited StatesNot yet recruiting
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New YorkUnited StatesRecruiting
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PeoriaUnited StatesNot yet recruiting
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PhoenixUnited StatesRecruiting
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PittsburghUnited StatesNot yet recruiting
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PortlandUnited StatesWithdrawn
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RichmondUnited StatesNot yet recruiting
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RochesterUnited StatesRecruiting
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Saint PaulUnited StatesNot yet recruiting
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Salt Lake CityUnited StatesNot yet recruiting
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San DiegoUnited StatesNot yet recruiting
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Santa MonicaUnited StatesNot yet recruiting
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ShenandoahUnited StatesNot yet recruiting
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SpringfieldUnited StatesRecruiting
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TacomaUnited StatesRecruiting
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TylerUnited StatesNot yet recruiting
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WilmingtonUnited StatesNot yet recruiting
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Winston-SalemUnited StatesNot yet recruiting
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YpsilantiUnited StatesNot yet recruiting
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AnkaraTurkey (Türkiye)Not yet recruiting
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IstanbulTurkey (Türkiye)Not yet recruiting
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IzmirTurkey (Türkiye)Withdrawn

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