Efficacy and Safety Study of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients

IDENTIFIERS

Trial Protocol: SHP620-302

Clinicaltrials.gov: NCT02927067

EudraCT: 2015-004726-34

PURPOSE

The purpose of this study is to compare the efficacy of maribavir to valganciclovir for the treatment of cytomegalovirus (CMV) infection in asymptomatic hematopoietic stem cell transplant (HSCT) recipients.

Recruiting

15+

Trial at a glance

What medical condition is being studied? Cytomegalovirus (CMV)

What is the trial testing? Maribavir; Valganciclovir; Placebo

Are placebos part of the trial? No

How many participants are being enrolled? 550

When is the trial being conducted? Apr 2017 - Jul 2021

How long is participation in the trial? Planned duration of screening phase: 2 weeks, planned duration of treatment phase: 8 weeks, planned duration of follow-up phase: 12 weeks. All patients who meet the eligibility requirements during the screening phase will be randomly selected to receive either maribavir or valganciclovir during the 8 week treatment phase. This study requires approximately 18 visits to the study site.

Key requirements

Sex

All

Age

From 16 Years

Accepts Healthy Volunteers?

Trial Details / Participation Requirements

CLICK TO EXPANDCLICK TO COLLAPSE

Trial phase: Phase 3

Trial Type: Interventional

Trial Arms/Groups or Cohorts:

Maribavir/ Placebo: Participants will receive 400 milligrams (mg) of maribavir (2*200 mg tablets) twice daily (BID) orally along with a placebo matched to valganciclovir for 8 weeks.

Valganciclovir/ Placebo: Participants will receive 900 mg of valganciclovir (2*450 mg tablets) BID orally along with a placebo matched to maribavir for 8 weeks. Valganciclovir dose may be adjusted to 450 mg BID or 450 mg QD during the study for renal function impairment or neutropenia.

Intervention: Maribavir; Valganciclovir; Placebo

Primary Outcome Measure(s):

Proportion of Participants With Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at the End of Study Week 8, Regardless of Whether Study Assigned Treatment was Completed [Time Frame: Week 8]

Secondary Outcome Measure(s):

Proportion of Participants Who Maintained Confirmed CMV Viremia Clearance Achieved at the End of Study Week 8 Through Study Week 16, Regardless of Whether Study Assigned Treatment was Completed [Time Frame: Week 8 through Week 16]

Proportion of Participants Who Achieve Confirmed CMV Viremia Clearance After 8 Weeks of Receiving Study-assigned Treatment [Time Frame: Week 8]

Proportion of Participants Who Maintained Confirmed CMV Viremia Clearance After Completion of 8 Weeks of Receiving Study-Assigned Treatment Through Study Weeks 12, 16 and 20 [Time Frame: Week 8 through Weeks 12, 16 and 20]

Proportion of Participants Who Maintained Confirmed CMV Viremia Clearance After Completion of 8 Weeks of Receiving Study-Assigned Treatment Through Study Weeks 12, 16 and 20 Regardless of Whether Study Assigned Treatment was Completed [Time Frame: Week 8 through Weeks 12, 16 and 20]

Proportion of Participants With Confirmed Recurrence of Viremia While on Study Treatment and Off Treatment [Time Frame: Baseline up to Week 20]

Incidence of Grade 3 or 4 Neutropenia [Time Frame: Baseline up to Week 8]

Number of Participants With Treatment-Emergent Adverse Events [Time Frame: Baseline up to Week 20]

Predose Concentration (Cmin) of Maribavir [Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]

Area Under the Concentration-Time Curve Over the 12-Hour Dosing Interval at Steady State AUC(0-tau) of Maribavir [Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]

Maximum Observed Plasma Concentration (Cmax) of Maribavir [Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]

Time When Maximum Concentration is Observed (Tmax) of Maribavir [Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]

Apparent Oral Clearance (CL/F) of Maribavir [Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]

Apparent Volume of Distribution (Vz/F) of Maribavir [Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]

Entry Criteria:

Recipient of hematopoietic stem cell transplant Have a documented asymptomatic CMV infection If presenting with recurrent CMV infection, have at least 2 weeks of undetectable CMV DNA Must not have a CMV infection that is known to be genotypically resistant to ganciclovir, valganciclovir, foscarnet, or cidofovir Must not require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated Must not be receiving leflunomide, or artesunate when study treatment is initiated Must not be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet or cidofovir) for the current CMV infection for longer than 72 hours.

Trial Locations

RESULTS

UCLA Medical Center

757 Westwood Plaza, Los Angeles, CA 90095, USA

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310-825-6264

dwinston@mednet.ucla.edu

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Stanford University

450 Serra Mall, Stanford, CA 94305, USA

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650-868-8073

wesbrown@stanford.edu

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Yale University School of Medicine

333 Cedar St, New Haven, CT 06510, USA

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203-785-3561

maricar.malinis@yale.edu

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Emory University

201 Dowman Dr, Atlanta, GA 30322, USA

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404-712-2051

gmlyon@emory.edu

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Loyola University Medical Center

2160 S 1st Ave, Maywood, IL 60153, USA

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708-327-3157

Patrick.Hagen@lumc.edu

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University of Maryland School of Medicine

655 W Baltimore St S, Baltimore, MD 21201, USA

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410-328-0386

jyared@umm.edu

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Johns Hopkins Hospital

1800 Orleans St, Baltimore, MD 21287, USA

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443-287-4694

ravery4@jhmi.edu

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Beth Israel Deaconess Medical Center

330 Brookline Ave, Boston, MA 02215, USA

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617-732-8881

fmarty@partners.org

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Brigham and Womens Hospital

75 Francis St, Boston, MA 02115, USA

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617-732-8881

fmarty@partners.org

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UMass Memorial Medical Center

55 N Lake Ave, Worcester, MA 01655, USA

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508-856-1978

laura.gibson@umassmed.edu

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Henry Ford Health System

1 Ford Pl, Detroit, MI 48202, USA

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313-916-2573

galanga1@hfhs.org

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University of Minnesota

Minneapolis, MN 55455, USA

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612-625-8642

vanbu004@umn.edu

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Hackensack University Medical Center

30 Prospect Ave, Hackensack, NJ 07601, USA

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551-996-5234

scott.rowley@hackensackmeridian.org

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Joan and sandford I. Weill Medical College of Cornell University Clinic

1300 York Ave, New York, NY 10065, USA

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212-746-2646

tbs2001@med.cornell.edu

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Memorial Sloan Kettering Cancer Center

1275 York Ave, New York, NY 10065, USA

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212-639-8361

papanicg@mskcc.org

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University of Pennsylvania

Philadelphia, PA 19104, USA

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215-662-7066

blumbere@pennmedicine.upenn.edu

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VA Puget Sound Health Care System - NAVREF

1660 S Columbian Way, Seattle, WA 98108, USA

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206-764-2969

tchaunce@u.washington.edu

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The Medical College of Wisconsin, Inc.

8701 W Watertown Plank Rd, Wauwatosa, WI 53226, USA

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414-805-4600

phari@mcw.edu

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Royal Adelaide Hospital

Port Rd, Adelaide SA 5000, Australia

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+61870740000

deepak.singhal@sa.gov.au

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Royal Melbourne Hospital

Royal Melbourne Hospital, Parkville VIC 3050, Australia

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+61393429407

joe.sasadeusz@mh.org.au

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UZ Antwerpen

Drie Eikenstraat 655, 2650 Edegem, Belgium

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+3238213250

alain.gadisseur@uza.be

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Institute Jules Bordet

Boulevard de Waterloo 121, 1000 Bruxelles, Belgium

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+3225413706

mickael.aoun@bordet.be

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Cliniques Universitaires Saint-Luc

Avenue Hippocrate 10, 1200 Bruxelles, Belgium

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+3227641809

xavier.poire@uclouvain.be

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University Hospital Gent

Corneel Heymanslaan 10, 9000 Gent, Belgium

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Herestraat 49, 3000 Leuven, Belgium

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AZ Sint-Jan AV

Ruddershove 10, 8000 Brugge, Belgium

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+3250453061

dominik.selleslag@azsintjan.be

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CHU de Liège

Avenue de L'Hôpital 1, 4000 Liège, Belgium

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+3243667201

e.willems@chu.ulg.ac.be

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Vancouver General Hospital

899 W 12th Ave, Vancouver, BC V5Z 1M9, Canada

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(604) 875-4588

alissa.wright@ubc.ca

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Hamilton Health Sciences Corporation

100 King St W, Hamilton, ON L8N 3Z5, Canada

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(905) 521-2100

haider@mcmaster.ca

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University Hospital Center Zagreb

Kišpatićeva ul. 12, 10000, Zagreb, Croatia

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+38598230220

rvrhovac@mef.hr

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Fakultni nemocnice v Motole

V Úvalu 84, 150 06 Praha 5, Czechia

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+420224436433

petr.sedlacek@lfmotol.cuni.cz

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Ustav hematologie a krevni transfuze

1, U Nemocnice 2094, 128 20 Nové Město, Czechia

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(420) 221-9772

marketa.markova@uhkt.cz

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CHU de Bordeaux

Avenue du Haut Lévêque, 33604 Pessac, France

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laurence.clement@chu-bordeaux.fr

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CHU de GRENOBLE

Avenue Maquis du Grésivaudan, 38700 La Tronche, France

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Hôtel Dieu

1 Place Alexis-Ricordeau, 44000 Nantes, France

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patrice.chevallier@chu-nantes.fr

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CHU Angers

4 Rue Larrey, 49100 Angers, France

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+332413544724475

syfrancois@chu-angers.fr

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Hopital Henri Mondor

51 Avenue du Maréchal de Lattre de Tassigny, 94010 Créteil, France

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+33149812057

catherine.cordonnier@hmn.aphp.fr

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Hopital Jean Minjoz

3 Boulevard Alexandre Fleming, 25000 Besançon, France

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+33381668232

edeconinck@chu-besancon.fr

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Hôpital Universitaire Dupuytren

2 Avenue Martin Luther King, 87000 Limoges, France

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+33555058039

pascal.turlure@chu-limoges.fr

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Hôpital Saint Louis

1 Avenue Claude Vellefaux, 75010 Paris, France

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+33142499639

david.michonneau@aphp.fr

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EDOG - Institut Claudius Regaud - PPDS

1 Av. Irène Joliot-Curie, 31100 Toulouse, France

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+33531156354

huynh.anne@iuct-oncopole.fr

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Universität des Saarlandes

Kirrberger Str. 100, 66421 Homburg, Germany

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+4968411615000

niels.murawski@uks.eu

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Universitatsklinikum Leipzig

Liebigstraße 20, 04103 Leipzig, Germany

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+493419713020

georg-nikolaus.franke@medizin.uni-leipzig.de

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Universitätsklinikum Augsburg

Stenglinstraße 2, 86156 Augsburg, Germany

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+498214002353

christoph.schmid@klinikum-augsburg.de

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Helios Klinikum Berlin-Buch

Schwanebecker Chaussee 50, 13125 Berlin, Germany

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+4930940152151

herrad.baurmann@helios-gesundheit.de

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Martin Luther Universitat Halle Wittenberg

Von-Danckelmann-Platz 3, 06120 Halle (Saale), Germany

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+493455577250

lutz.mueller@uk-halle.de

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Universitätsklinikum Hamburg Eppendorf

Martinistraße 52, 20251 Hamburg, Germany

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+4940741055250

m.christopeit@uke.de

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Universitätsklinik Rostock

Schillingallee 35, 18057 Rostock, Germany

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+493814947421

christian.junghanss@med.uni-rostock.de

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Robert Bosch Krankenhaus

Robert-Bosch-Krankenhaus, 70376 Stuttgart, Germany

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+4971181015431

martin.kaufmann@rbk.de

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Universitätsklinikum Tübingen

Hoppe-Seyler-Straße 3, 72076 Tübingen, Germany

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+4970712982711

wolfgang.bethge@med.uni-tuebingen.de

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Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet

Budapest, Nagyvárad tér 1, 1097 Hungary

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+3614558100

gopcsa.laszlo@dpckorhaz.hu

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Ospedale Infantile Regina Margherita

Piazza Polonia, 94, 10126 Torino TO, Italy

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+390113135230

franca.fagioli@unito.it

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Azienda Ospedaliera Universitaria Integrata Di Verona

Piazzale Aristide Stefani, 1, 37126 Verona VR, Italy

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+390458124443

cristina.tecchio@univr.it

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Azienda Ospedaliera Universitaria Careggi

Largo Piero Palagi, 1, 50139 Firenze FI, Italy

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+393471226642

cutini.ilaria@hotmail.com

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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Via della Commenda, 10, 20122 Milano MI, Italy

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+3902550333353742

fonida@gmail.com

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Fondazione Policlinico Universitario A Gemelli

Via Giuseppe Moscati, 31, 00168 Roma RM, Italy

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+393355267999

patrizia.chiusolo@unicatt.it

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Azienda Ospedaliera Città della Salute e della Scienza di Torino

Corso Bramante, 88, 10126 Torino TO, Italy

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(888) 888-8888

abusca.clinicaltrials@gmail.com

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Dong-A University Hospital

26 Daesingongwon-ro, Dongdaesin 3(sam)-dong, Seo-gu, Busan, South Korea

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Keimyung University Dongsan Hospital

1035 Dalgubeol-daero, Sindang-dong, Dalseo-gu, Daegu, South Korea

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Auckland City Hospital

2 Park Road, Grafton, Auckland 1023, New Zealand

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+6493737599

p.browett@auckland.ac.nz

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Canterbury Health Laboratories

Hagley Avenue, Addington, Christchurch 8011, New Zealand

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+6433640392

andrew.butler@cdhb.health.nz

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Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

Borowska 213, 50-556 Wrocław, Poland

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+48717842576

wrobel.t@onet.pl, twrobel@usk.wroc.pl

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MTZ Clinical Research Sp z o o

Adolfa Pawińskiego 5, 02-106 Warszawa, Poland

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+48225725959

wieslaw.jedrzejczak@wum.edu.pl

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Uniwersyteckie Centrum Kliniczne - PPDS

Mariana Smoluchowskiego 17, 80-214 Gdańsk, Poland

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+48583493079

mbienia@gumed.edu.pl

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National University Hospital

5 Lower Kent Ridge Rd, Singapore 119074

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+656321470

liang_piu_koh@nuhs.edu.sg

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Singapore General Hospital (SGH)

Outram Rd, Singapore 169608

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aloysius.ho.y.l@sgh.com.sg

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Hospital Universitario Germans Trias i Pujol

Carretera de Canyet, s/n, 08916 Badalona, Barcelona, Spain

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+34934978987

cferra@iconcologia.net

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Hospital Universitario Marques de Valdecilla

Av. Valdecilla, 25, 39008 Santander, Cantabria, Spain

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+34942202520

maranzazu.bermudez@scsalud.es

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Complejo Asistencial Universitario de Salamanca - H. Clinico

Paseo de San Vicente, 58, 37007 Salamanca, Spain

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+34923291316

lvazlo@usal.es

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Hospital Universitario Vall d'Hebrón - PPDS

Passeig de la Vall d'Hebron, 119, 08035 Barcelona, Spain

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+34932746414

pbarba@vhio.net

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ICO l'Hospitalet - Hospital Duran i Reynals

Avinguda de la Granvia de l’Hospitalet, 199, 08908 L'Hospitalet de Llobregat, Barcelona, Spain

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+34932607750

rparody@iconcologia.net

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C.H. Regional Reina Sofia - PPDS

Av. Menendez Pidal, s/n, 14004 Córdoba, Spain

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+34957012972

rrojashurs@hotmail.com

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Hospital Universitario Virgen de Las Nieves

Av. de las Fuerzas Armadas, 2, 18014 Granada, Spain

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+34958020379

manuel.jurado.sspa@juntadeandalucia.es

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Hospital Universitario de La Princesa

Calle de Diego de León, 62, 28006 Madrid, Spain

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+34915202316

jrcamara@telefonica.net

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Hospital Universitario Ramon y Cajal

M-607, km. 9, 100, 28034 Madrid, Spain

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+34913368362

jlopezj.hrc@salud.madrid.org

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Hospital Universitario Puerta de Hierro - Majadahonda

Calle Joaquín Rodrigo, 1, 28222 Majadahonda, Madrid, Spain

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+34911917809

rduarte.work@gmail.com

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Hospital Regional Universitario de Malaga - Hospital General

Av. de Carlos Haya, 84, 29010 Málaga, Spain

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+34942202520

ai.gallardomorillo@gmail.com

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Hospital Universitario de Donostia

20014 San Sebastián-Donostia, Guipúzcoa, Spain

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+34943007041

OSID.ZERBITZUHEMATOLOGIA-TPH@osakidetza.eus

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Hospital Clinico Universitario de Valencia

Av. de Blasco Ibáñez, 17, 46010 València, Valencia, Spain

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+34963862625

csolano.work@gmail.com

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Hospital Universitari i Politecnic La Fe de Valencia

Avinguda de Fernando Abril Martorell, 106, 46026 València, Valencia, Spain

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+34961245876

sanz_jai@gva.es

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Universitätsspital Zürich

Rämistrasse 100, 8091 Zürich, Switzerland

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+41442553712

nicolas.mueller@usz.ch

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Baskent University Medical Faculty Adana Practice and Research Center

Bağlıca Kampüsü, Dumlupınar Blv. 20. Km, 06810 Etimesgut/Ankara, Turkey

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+00905322366797

hakanozdogu@hotmail.com

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Ankara University Medica Faculty Hematology Department Clinical Research Area PPDS

Emniyet, Dögol Cd. 6A, 06560 Yenimahalle/Ankara, Turkey

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+903125957375

gurman@medicine.ankara.edu.tr

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Birmingham Heartlands Hospital

Bordesley Green E, Birmingham B9 5SS, UK

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+441214243699

bhuvan.kishore@heartofengland.nhs.uk

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Hammersmith Hospital

72 Du Cane Rd, London W12 0HS, UK

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+442083835101

dragana.milojkovic@nhs.net

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University College London

Gower St, Bloomsbury, London WC1E 6BT, UK

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+442076796236

karl.peggs@ucl.ac.uk

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St George's Hospital

Blackshaw Rd, Tooting, London SW17 0QT, UK

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+442087253545

mickey.koh@stgeorges.nhs.uk

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Royal Liverpool University Hospital

Prescot St, Liverpool L7 8XP, UK

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+441517064639

rahuman.salim@rlbuht.nhs.uk

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The Christie NHS Foundation Trust - PPDS

Wilmslow Rd, Manchester M20 4BX, UK

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+441614463869

adrian.bloor@christie.nhs.uk

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Southampton University Hospitals NHS Trust

Southampton General Hospital, Tremona Rd, Southampton SO16 6YD, UK

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+442381204163

k.h.orchard@southampton.ac.uk; kho@soton.ac.uk

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University of Alabama at Birmingham

Birmingham, AL 35294, USA

205-934-5191

jbaddley@uab.edu

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Colorado Blood Cancer Institute

1721 E 19th Ave ste 200-300, Denver, CO 80218, USA

(720) 754-4800

richard.nash@healthonecares.com

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University of Chicago

5801 S Ellis Ave, Chicago, IL 60637, USA

(773) 702-3756

kmullane@medicine.bsd.uchicago.edu

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Mayo Clinic - PPDS

200 1st St SW, Rochester, MN 55905, USA

507-284-3747

razonable.raymund@mayo.edu

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Columbia University Medical Center

630 W 168th St, New York, NY 10032, USA

212-342-0530

rr336@cumc.columbia.edu

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TriStar Centennial Medical Center

2300 Patterson St, Nashville, TN 37203, USA

(210) 575-6904

carlos.bachier@hcahealthcare.com

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Saint Davids South Austin Medical Center

901 W Ben White Blvd, Austin, TX 78704, USA

(201) 575-6904

aravind.ramakrishnan@HCAhealthcare.com

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University of Texas MD Anderson Cancer Center

1515 Holcombe Blvd, Houston, TX 77030, USA

(713) 792-5381

rfchemaly@mdanderson.org

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Texas Transplant Institute

8201 Ewing Halsell Dr, San Antonio, TX 78229, USA

(210) 575-8500

paul.shaughnessy@mhshealth.com

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Westmead Hospital

Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145, Australia

+61298457073

emily.blyth@sydney.edu.au

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Queen Elizabeth II Health Sciences Center

1276 South Park St, Halifax, NS B3H 2Y9, Canada

(902) 473-4642

stephen.couban@nshealth.ca

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Hopital de Hautepierre

1 Avenue Molière, 67200 Strasbourg, France

+33388116728

bruno.lioure@chru-strasbourg.fr

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Institut Paoli Calmettes

232 Boulevard de Sainte-Marguerite, 13009 Marseille, France

+33

izadifarf@ipc.unicancer.fr

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Universitätsklinikum Münster

Albert-Schweitzer-Campus 1, 48149 Münster, Germany

+4902518352801

stelljes@uni-muenster.de

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Ospedale Dell'Angelo

Via Paccagnella, 11, 30174 Venezia VE, Italy

+390419657357

michele.vespignani@aulss3.veneto.it

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Trial Protocol ID: SHP620-302

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