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NCT04562389Active, not recruitingPhase 3

Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

A Phase 1/3 Study to Evaluate Efficacy and Safety of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination With Ruxolitinib in Treatment-naïve Patients With Myelofibrosis

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

This is a global, multicenter, 2-part study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended Phase 2 dose (RP2D) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). Phase 3 (ongoing), double-blind, placebo-controlled part of the study comparing the efficacy and safety of combination therapy of selinexor + ruxolitinib with combination of placebo + ruxolitinib.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
353 (actual)
First submitted
14 Sept 2020
Start date
11 Mar 2021
Primary completion date
20 Feb 2026
Lead sponsor
Karyopharm Therapeutics Inc
NCT number
NCT04562389
EU CT number
2023-506139-13-00
EudraCT number
2020-003883-19

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 353
  • From 11 Mar 2021 to the primary completion date, 20 Feb 2026
  • 166 sites in 20 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

  • Previous treatment with JAK inhibitors for MF.
  • Previous treatment with selinexor or other XPO1 inhibitors.

Other

  • More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase).

Who the study is looking for

  • Aged ≥ 18 years
  • A diagnosis of primary MF or post-essential thrombocythemia (ET) or postpolycythemia- vera (PV) MF.
  • Active symptoms of MF as determined by presence of at least 2 symptoms using the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0.
  • Participants with international prognostic scoring system (DIPSS) risk category of intermediate-1, or intermediate-2, or high-risk.
  • Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (\>=) 450 cubic centimeter (cm\^3) .
  • Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (\<=) 2.

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

Full criteria on ClinicalTrials.gov

Sites (166)

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

SiteCityCountrySite status
Royal Adelaide Hospital
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AdelaideAustraliaUnknown status
Bankstown-Lidcombe Hospital
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BankstownAustraliaUnknown status
Campbelltown Hospital
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CampbelltownAustraliaUnknown status
Liverpool Hospital
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LiverpoolAustraliaUnknown status
One Clinical Research
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NedlandsAustraliaUnknown status
Icon Cancer Centre Wesley
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South BrisbaneAustraliaUnknown status
ZNA Stuivenberg
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AntwerpBelgiumUnknown status
ZNA Stuivenberg - Satelite
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AntwerpBelgiumUnknown status
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
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BrugesBelgiumUnknown status
Universitair Ziekenhuis Gent
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GhentBelgiumUnknown status
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
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LeuvenBelgiumUnknown status
University Multiprofile Hospital for Active Treatment Sveti George - Base 1
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PlovdivBulgariaUnknown status
University Multiprofile Hospital for Active Treatment St. Ivan Rilski
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SofiaBulgariaUnknown status
University Multiprofile Hospital for Active Treatment Aleksandrovska
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SofiaBulgariaUnknown status
Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia
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SofiaBulgariaUnknown status
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich
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Stara ZagoraBulgariaUnknown status
University of Alberta Hospital
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EdmontonCanadaUnknown status
Research Institute of the McGill University Health Centre
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MontrealCanadaUnknown status
Lakeridge Health
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OshawaCanadaUnknown status
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaUnknown status
Fakultni nemocnice Olomouc
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OlomoucCzechiaUnknown status
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaUnknown status
Marien Hospital Düsseldorf
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DüsseldorfGermanyUnknown status
Universitätsklinikum Halle
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HalleGermanyUnknown status
Universitätsklinikum Jena
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JenaGermanyUnknown status
Städtisches Krankenhaus Kiel
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KielGermanyUnknown status
Kliniken Ostalb Stauferklinikum Schwäbisch Gmünd
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MutlangenGermanyUnknown status
Tang Severinsen, Marianne
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AalborgDenmarkUnknown status
Aarhus Universitetshospital
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Aarhus NDenmarkUnknown status
Institut Català d'Oncologia Badalona
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BadalonaSpainUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
Hospital San Pedro De Alcántara
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CáceresSpainUnknown status
Institut Català d&#39;Oncologia Girona (ICO Girona)
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GironaSpainUnknown status
Hospital Universitario de Gran Canaria Doctor Negrín
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Las Palmas de Gran CanariaSpainUnknown status
Hospital Universitario Lucus Augusti
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LugoSpainUnknown status
Hospital Universitario Ramón y Cajal
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MadridSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital General Universitario Gregorio Marañón
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MadridSpainUnknown status
Hospital Universitario Virgen de la Victoria
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MálagaSpainUnknown status
Hospital Clínico Universitario Virgen de la Arrixaca
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MurciaSpainUnknown status
Hospital Universitario Central De Asturias
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OviedoSpainUnknown status
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
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SalamancaSpainUnknown status
Hospital Clinico Universitario de Valencia
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ValenciaSpainUnknown status
Hospital de Dia Quironsalud Zaragoza
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ZaragozaSpainUnknown status
Centre Hospitalier Universitaire D'Angers
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AngersFranceUnknown status
Institut Bergonie
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BordeauxFranceUnknown status
Hopital Morvan
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BrestFranceUnknown status
Centre Hospitalier Universitaire Estaing
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Clermont-FerrandFranceUnknown status
Hopital Huriez
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LilleFranceUnknown status
Hôpital Emile Muller
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MulhouseFranceUnknown status
Hôpital l'Archet - CHU Nice
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NiceFranceUnknown status
CHU de Nîmes - Institut de Cancérologie du Gard
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NîmesFranceUnknown status
Hôpital Universitaire Pitié Salpêtrière
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ParisFranceUnknown status
Hopital Saint Louis
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ParisFranceUnknown status
Hôpital Cochin
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ParisFranceUnknown status
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceUnknown status
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceUnknown status
Hopital Bretonneau
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ToursFranceUnknown status
United Lincolnshire Hospitals NHS Trust
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BostonUnited KingdomUnknown status
United Lincolnshire Hospitals NHS Trust-Satellite Site
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BostonUnited KingdomUnknown status
The Clatterbridge Cancer Centre NHS Foundation Trust
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LiverpoolUnited KingdomUnknown status
Imperial College Healthcare NHS Trust
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LondonUnited KingdomUnknown status
Guy's and St Thomas' NHS Foundation Trust
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LondonUnited KingdomUnknown status
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
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Newcastle upon TyneUnited KingdomUnknown status
Oxford University Hospitals NHS Foundation Trust
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OxfordUnited KingdomUnknown status
University General Hospital Attikon
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AthensGreeceUnknown status
General Hospital of Athens - Alexandra
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AthensGreeceUnknown status
Laiko General Hospital of Athens
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AthensGreeceUnknown status
University General Hospital of Ioannina
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IoanninaGreeceUnknown status
University General Hospital of Larissa, Hematology Department
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LarissaGreeceUnknown status
General Hospital of Thessaloniki ""George Papanikolaou""
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ThessalonikiGreeceUnknown status
Semmelweis Egyetem
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BudapestHungaryUnknown status
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryUnknown status
Emek Medical Center
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AfulaIsraelUnknown status
Shamir Medical Center
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Be’er Ya‘aqovIsraelUnknown status
Rambam Health Care Campus
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HaifaIsraelUnknown status
Carmel Medical Center
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HaifaIsraelUnknown status
Hadassah University Hospital - Ein Kerem
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JerusalemIsraelUnknown status
Hadassah University Hospital - Mount Scopus
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JerusalemIsraelUnknown status
Galilee Medical Center
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NahariyaIsraelUnknown status
The Chaim Sheba Medical Center
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Ramat GanIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
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BolognaItalyUnknown status
Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco - Catania/ Presidio G. Rodolico
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CataniaItalyUnknown status
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyUnknown status
IRCCS Ospedale Policlinico San Martino
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GenovaItalyUnknown status
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
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MeldolaItalyUnknown status
Istituto Europeo di Oncologia
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MilanItalyUnknown status
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyUnknown status
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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MilanItalyUnknown status
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyUnknown status
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
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NovaraItalyUnknown status
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyUnknown status
IRCCS Centro di Riferimento Oncologico di Basilicata
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Rionero in VultureItalyUnknown status
Umberto I - Policlinico di Roma
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RomaItalyUnknown status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomaItalyUnknown status
Università Campus Bio-Medico di Roma
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RomeItalyUnknown status
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
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TorinoItalyUnknown status
Azienda Ospedaliera Ordine Mauriziano di Torino
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TorinoItalyUnknown status
Centro Ricerche Cliniche Di Verona
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VeronaItalyUnknown status
Pusan National University Hospital
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BusanSouth KoreaUnknown status
Kyungpook National University Hospital
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DaeguSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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HwasunSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
Severance hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaUnknown status
Universitair Medisch Centrum Groningen
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GroningenNetherlandsUnknown status
Spaarne Gasthuis - Hoofddorp
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HoofddorpNetherlandsUnknown status
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
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BrzozówPolandUnknown status
Uniwersyteckie Centrum Kliniczne w Gdańsku
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GdanskPolandUnknown status
Pratia Onkologia Katowice
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KatowicePolandUnknown status
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandUnknown status
Aidport
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SkorzewoPolandUnknown status
Medicover Integrated Clinical Services (MICS) - Centrum Medyczne Toruń
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TorunPolandUnknown status
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
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WałbrzychPolandUnknown status
Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
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WroclawPolandUnknown status
Spitalul Clinic Colentina
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BucharestRomaniaUnknown status
Coltea - Spital Clinic
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BucharestRomaniaUnknown status
Institutul Oncologic Prof. Dr. Ion Chiricuta
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Cluj-NapocaRomaniaUnknown status
Spitalul Filantropia - Craiova
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CraiovaRomaniaUnknown status
Institutul Regional de Oncologie Iasi
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IașiRomaniaUnknown status
Spitalul Clinic Judetean de Urgenta Targu Mures
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Târgu MureşRomaniaUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Chang Gung Memorial Hospital - Kaohsiung Branch
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Kaohsiung CityTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Chang Gung Memorial Hospital, Linkou Branch
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TaoyuanTaiwanUnknown status
Maryland Oncology Hematology-Satellite
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AnnapolisUnited StatesUnknown status
USOR - Rocky Mountain Cancer Centers - Aurora
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AuroraUnited StatesUnknown status
The Sidney Kimmel Comprehensive Cancer Center
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BaltimoreUnited StatesUnknown status
UCLA - Satellite Site
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Beverly HillsUnited StatesUnknown status
UAB Division of Hematology/Oncology
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BirminghamUnited StatesUnknown status
Maryland Oncology Hematology-Satellite
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BrandywineUnited StatesUnknown status
USOR - Oncology Hematology Care - Kenwood
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CincinnatiUnited StatesUnknown status
Maryland Oncology Hematology
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ColumbiaUnited StatesUnknown status
OhioHealth
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ColumbusUnited StatesUnknown status
Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute
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ColumbusUnited StatesUnknown status
Texas Oncology
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DallasUnited StatesUnknown status
City of Hope
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DuarteUnited StatesUnknown status
Duke Cancer Institue
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DurhamUnited StatesUnknown status
UCLA - Satellite Site
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EncinoUnited StatesUnknown status
USOR - Virginia Cancer Specialists - Gainesville Office
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GainesvilleUnited StatesUnknown status
The Cancer & Hematology Centers -Satellite Site
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Grand RapidsUnited StatesUnknown status
John Theurer Cancer Center at Hackensack University Medical Center
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HackensackUnited StatesUnknown status
University of Texas - MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
City of Hope - Irvine Lennar - Satellite
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IrvineUnited StatesUnknown status
UCLA
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Los AnglesUnited StatesUnknown status
Norton Cancer Institute - Saint Matthews
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LouisvilleUnited StatesUnknown status
University of Wisconsin - Madison
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MadisonUnited StatesUnknown status
Vanderbilt-Ingram Cancer Center
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NashvilleUnited StatesUnknown status
Smilow Cancer Hospital - New Haven
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New HavenUnited StatesUnknown status
Mount Sinai Health System
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
The Cancer & Hematology Centers of Muskegon
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Norton ShoresUnited StatesUnknown status
The Oncology Institute of Hope & Innovation
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PasadenaUnited StatesUnknown status
VCU Massey Cancer Center
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RichmondUnited StatesUnknown status
Maryland Oncology Hematology-Satellite
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RockvilleUnited StatesUnknown status
Huntsman Cancer Institute
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Salt Lake CityUnited StatesUnknown status
Fred Hutchinson Cancer Center - SCAA South Lake Union
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SeattleUnited StatesUnknown status
Maryland Oncology Hematology-Satellite
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Silver SpringUnited StatesUnknown status
USOR - Virginia Oncology Associates - Virginia Beach
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Virginia BeachUnited StatesUnknown status
Georgetown Lombardi Comprehensive Center
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Washington D.C.United StatesUnknown status
West Virginia University Cancer Institute, Wheeling Hospital
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WheelingUnited StatesUnknown status

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