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NCT03682536Active, not recruitingPhase 3

A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) in ESA Naïve Subjects Who Require Red Blood Cell Transfusions

Source: ClinicalTrials.gov · Last updated 20 Nov 2024

Brief summary (registry, in English)

The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
363 (actual)
First submitted
7 Sept 2018
Start date
2 Jan 2019
Primary completion date
31 Mar 2023
Lead sponsor
Celgene
NCT number
NCT03682536
EudraCT number
2022-501485-22

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 363
  • From 2 Jan 2019 to the primary completion date, 31 Mar 2023
  • 226 sites in 26 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.

Other illness

  • Clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or hypothyroidism, or any type of known clinically significant bleeding or sequestration or drug induced anemia
  • Known history of diagnosis of Acute myeloid leukemia (AML)
  • Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure (SBP) of ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
    • Other protocol-defined inclusion/exclusion criteria apply

Who the study is looking for

  • Documented diagnosis of Myelodysplastic syndromes (MDS) according to WHO 2016 classification that meets revised international prognostic scoring system (IPSS-R) classification of very low, low, or intermediate risk disease, and have \< 5% blasts in bone marrow
  • Endogenous serum erythropoietin (sEPO) level of \< 500 U/L
  • Requires Red blood cell (RBC) transfusions, as documented by the criteria: Average transfusion requirement of 2 - 6 units/8 weeks of packed red blood cells (pRBCs) confirmed for a minimum of 8 weeks immediately preceding randomization
  • Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2

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

Full criteria on ClinicalTrials.gov

Sites (226)

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

SiteCityCountrySite status
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LinzAustriaUnknown status
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ViennaAustriaUnknown status
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AdelaideAustraliaUnknown status
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AlburyAustraliaUnknown status
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AuchenflowerAustraliaUnknown status
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BlacktownAustraliaUnknown status
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ClaytonAustraliaUnknown status
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ConcordAustraliaUnknown status
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KogarahAustraliaUnknown status
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MalvernAustraliaUnknown status
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MelbourneAustraliaUnknown status
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NowraAustraliaUnknown status
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RandwickAustraliaUnknown status
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WaratahAustraliaUnknown status
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West PerthAustraliaUnknown status
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WollongongAustraliaUnknown status
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AntwerpBelgiumUnknown status
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BrasschaatBelgiumUnknown status
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BrusselsBelgiumUnknown status
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CharleroiBelgiumUnknown status
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KortrijkBelgiumUnknown status
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LeuvenBelgiumUnknown status
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RoeselareBelgiumUnknown status
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CalgaryCanadaUnknown status
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EdmontonCanadaUnknown status
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HamiltonCanadaUnknown status
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MontrealCanadaUnknown status
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MontrealCanadaUnknown status
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OttawaCanadaUnknown status
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SaskatoonCanadaUnknown status
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SherbrookeCanadaUnknown status
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TorontoCanadaUnknown status
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BernSwitzerlandUnknown status
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LucerneSwitzerlandUnknown status
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WinterthurSwitzerlandUnknown status
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Hradec KrálovéCzechiaUnknown status
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Ostrava-PorubaCzechiaUnknown status
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PragueCzechiaUnknown status
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PragueCzechiaUnknown status
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PragueCzechiaUnknown status
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Baden-WarttembergGermanyUnknown status
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BerlinGermanyUnknown status
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CologneGermanyUnknown status
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DresdenGermanyUnknown status
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DuisburgGermanyUnknown status
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DüsseldorfGermanyUnknown status
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HamburgGermanyUnknown status
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KeilGermanyUnknown status
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KoblenzGermanyUnknown status
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LeipzigGermanyUnknown status
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MannheimGermanyUnknown status
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MünchenGermanyUnknown status
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WinnendenGermanyUnknown status
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WürzburgGermanyUnknown status
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BarcelonaSpainUnknown status
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BarcelonaSpainUnknown status
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GranadaSpainUnknown status
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MadridSpainUnknown status
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MadridSpainUnknown status
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MálagaSpainUnknown status
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MurciaSpainUnknown status
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OurenseSpainUnknown status
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OviedoSpainUnknown status
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Palma de MallorcaSpainUnknown status
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SalamancaSpainUnknown status
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SevilleSpainUnknown status
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ValenciaSpainUnknown status
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ValenciaSpainUnknown status
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AngersFranceUnknown status
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BayonneFranceUnknown status
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CaenFranceUnknown status
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La TroncheFranceUnknown status
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Le MansFranceUnknown status
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LilleFranceUnknown status
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LimogesFranceUnknown status
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NantesFranceUnknown status
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NiceFranceUnknown status
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ParisFranceUnknown status
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ParisFranceUnknown status
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PessacFranceUnknown status
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Pierre-BéniteFranceUnknown status
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PoitiersFranceUnknown status
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StrasbourgFranceUnknown status
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ToulouseFranceUnknown status
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ToursFranceUnknown status
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Vandœuvre-lès-NancyFranceUnknown status
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AberdeenUnited KingdomUnknown status
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BournemouthUnited KingdomUnknown status
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Headington, OxfordUnited KingdomUnknown status
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LincolnUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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AlexandroupoliGreeceUnknown status
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AthensGreeceUnknown status
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AthensGreeceUnknown status
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AthensGreeceUnknown status
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AthensGreeceUnknown status
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HeraklionGreeceUnknown status
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PátraiGreeceUnknown status
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Rio PatrasGreeceUnknown status
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ThessalonikiGreeceUnknown status
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ThessalonikiGreeceUnknown status
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BudapestHungaryUnknown status
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DebrecenHungaryUnknown status
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NyíregyházaHungaryUnknown status
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HaifaIsraelUnknown status
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JerusalemIsraelUnknown status
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JerusalemIsraelUnknown status
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Kfar SabaIsraelUnknown status
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NahariyaIsraelUnknown status
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Tel AvivIsraelUnknown status
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TsrifinIsraelUnknown status
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BolognaItalyUnknown status
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FlorenceItalyUnknown status
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MeldolaItalyUnknown status
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MilanItalyUnknown status
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OrbassanoItalyUnknown status
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PadovaItalyUnknown status
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Reggio CalabriaItalyUnknown status
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RomaItalyUnknown status
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RomaItalyUnknown status
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RomeItalyUnknown status
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RozzanoItalyUnknown status
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UdineItalyUnknown status
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Amagasaki-ShiJapanUnknown status
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Fujisawa-ShiJapanUnknown status
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FukuokaJapanUnknown status
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Hitachi, IbarakiJapanUnknown status
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KamogawaJapanUnknown status
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Kitakyushu-ShiJapanUnknown status
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MatsuyamaJapanUnknown status
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Nagaoka-ShiJapanUnknown status
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NagasakiJapanUnknown status
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NagoyaJapanUnknown status
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ŌgakiJapanUnknown status
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OkayamaJapanUnknown status
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OsakaJapanUnknown status
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SagamiharaJapanUnknown status
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SapporoJapanUnknown status
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SayamaJapanUnknown status
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SendaiJapanUnknown status
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Shibuya-kuJapanUnknown status
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Shimotsuga-gunJapanUnknown status
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Shinagawa-ku, TokyoJapanUnknown status
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BusanSouth KoreaUnknown status
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DaeguSouth KoreaUnknown status
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Hwasun-GunSouth KoreaUnknown status
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Seongnam-siSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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KaunasLithuaniaUnknown status
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VilniusLithuaniaUnknown status
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AmsterdamNetherlandsUnknown status
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NijmegenNetherlandsUnknown status
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RotterdamNetherlandsUnknown status
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Sittard-GeleenNetherlandsUnknown status
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The HagueNetherlandsUnknown status
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GdanskPolandUnknown status
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LodzPolandUnknown status
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LubinPolandUnknown status
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PoznanPolandUnknown status
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RzwszowPolandUnknown status
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SłupskPolandUnknown status
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WałbrzychPolandUnknown status
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WroclawPolandUnknown status
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WroclawPolandUnknown status
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BejaPortugalUnknown status
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BragaPortugalUnknown status
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LisbonPortugalUnknown status
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PortoPortugalUnknown status
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SetúbalPortugalUnknown status
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KalugaRussiaUnknown status
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KirovRussiaUnknown status
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KrasnoyarskRussiaUnknown status
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MoscowRussiaUnknown status
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MoscowRussiaUnknown status
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MoscowRussiaUnknown status
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MoscowRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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SaratovRussiaUnknown status
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TulaRussiaUnknown status
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GothenburgSwedenUnknown status
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LundSwedenUnknown status
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StockholmSwedenUnknown status
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Changhua City, ChanghuaTaiwanUnknown status
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Niaosong District Kaohsiung CityTaiwanUnknown status
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TaichungTaiwanUnknown status
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TaichungTaiwanUnknown status
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TaipeiTaiwanUnknown status
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CherkassyUkraineUnknown status
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DniproUkraineUnknown status
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KyivUkraineUnknown status
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LvivUkraineUnknown status
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MykolaivUkraineUnknown status
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TernopilUkraineUnknown status
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BerkeleyUnited StatesUnknown status
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BethesdaUnited StatesUnknown status
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CharlottesvilleUnited StatesUnknown status
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ChesapeakeUnited StatesUnknown status
Baylor University Medical Center
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DallasUnited StatesUnknown status
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East BrunswickUnited StatesUnknown status
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GreenvilleUnited StatesUnknown status
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HackensackUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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HudsonUnited StatesUnknown status
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Kansas CityUnited StatesUnknown status
Tennessee Oncology
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PaducahUnited StatesUnknown status
Univ of Pittsburgh Medical Center
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PortlandUnited StatesUnknown status
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Rock HillUnited StatesUnknown status
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TallahasseeUnited StatesUnknown status
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WhittierUnited StatesUnknown status
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AnkaraTurkey (Türkiye)Unknown status
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ManisaTurkey (Türkiye)Unknown status
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TrabzonTurkey (Türkiye)Unknown status

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