Clinical Trial: A Survival Study in Patients with High Risk Myelodysplastic Syndromes Comparing Azacitidine versus Conventional Care


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Sponsored by:	Pharmion
Information provided by:	Pharmion

Condition	Treatment or Intervention	Phase
Myelodysplastic Syndromes	Drug: Azacitidine	Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Inclusion Criteria:

Have a diagnosis of refractory anemia with excess blasts or refractory anemia with excess blasts in transformation according to the French-American-British classification system for MDS and a relatively high risk of AML transformation, with an International Prognostic Scoring System score of INT-2 or High.
Be 18 years of age or older
Have a life expectancy of at least 3 months
Be unlikely to proceed to bone marrow or stem cell transplantation therapy following remission
Have serum bilirubin levels less than or equal to 1.5 times the upper limit of normal range for the laboratory
Have serum glutamic-oxaloacetic transaminase (aspartate aminotransferase) or serum glutamic-pyruvic transaminase (alanine aminotransferase) levels less than or equal to 2 times the upper limit of normal (unless these are considered to be related to transfusion-induced secondary hemosiderosis)
Have serum creatinine levels less than or equal to 1.5 times the upper limit of normal

Exclusion Criteria:

Secondary MDS
Prior treatment with azacitidine;
Prior history of AML;
Malignant disease diagnosed within prior 12 months;
Metastatic disease;
Hepatic tumors;
Radiation, chemotherapy, cytotoxic therapy for non-MDS conditions within prior 12 months;
Prior transplantation or cytotoxic therapy to treat MDS;
Serious medical illness likely to limit survival to 12 months or less;
Treatment with erythropoietin or myeloid growth factors during prior 21 days or androgenic hormones during prior 13 days;
Active HIV, viral hepatitis type B or C;
Treatment with investigational drugs during prior 30 days.

Alabama
University of Alabama School of Medicine, Birmingham, Alabama, 35294, United States; No longer recruiting

Indiana
Indiana University Cancer Center, Indianapolis, Indiana, 46202, United States; Recruiting

Larry Cripe, MD 317-274-3545 mbuckle@iupui.edu

Missouri
Washington University School of Medicine, St. Louis, Missouri, 63110, United States; Recruiting

Elizabeth Hiser 314-454-5090 ehiser@im.wustl.edu
John DiPersio, MD, PhD 314 454 8310 jdipersio@im.wustl.edu

New York
Mount Sinai Medical Center, New York, New York, 10029-6574, United States; Recruiting

Lewis Silverman, MD 212-241-6021 erin.demakos@mssm.edu

Ohio
Case Western Reserve University, Cleveland, Ohio, 44106, United States; No longer recruiting

Oregon
Oregon Cancer Center, Portland, Oregon, 97201, United States; No longer recruiting

Pennsylvania
Western Pennsylvania Cancer Institute, Pittsburgh, Pennsylvania, 15224, United States; No longer recruiting

Wisconsin
Froedtert Memorial Lutheran Hospital, Milwaukee, Wisconsin, 53226, United States; No longer recruiting

Australia, New South Wales
The Newcastle Mater Miseriecordiae Hospital, Warratah, New South Wales, 2298, Australia; Recruiting

Arno Enno, MBBS 61 2 4921 1215 Arno.Enno@mater.health.gov.au

Liverpool Hospital, Liverpool, New South Wales, 2170, Australia; Recruiting

John Gallo, MBBS 61 2 828 5167 John.Gallo@swahs.nsw.gov.au

Australia, Queensland
Princess Alexandra Hospital, Woolloongabba, Queensland, 4102, Australia; Recruiting

Anthony Mills 61 7 3240 2086 tony_mills@health.qld.gov.au

Royal Brisbane Hospital, Hersten, Queensland, 4029, Australia; Recruiting

Simon Durrant, DR 61 7 3636 1340

Australia, South Australia
Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia; Recruiting

Noemi Horvath 61 8 8222 3550

Australia, Victoria
The Alfred Hospital, Melbourne, Victoria, 3181, Australia; Recruiting

Andrew Spencer, MBBS 61 3 9276 3392 aspencer@netspace.net.au

Royal Melbourne Hospital, Melbourne, Victoria, 3050, Australia; Recruiting

Jeff Szer, DR 61 3 9342 7737 jeff.szer@mh.org.au

Peter MacCallum Cancer Institute, East Melbourne, Victoria, 3002, Australia; Recruiting

John Seymour, MBBS 61 3 9 656 1700 john.seymour@petermac.org

Australia, Western Australia
The Royal Perth Hospital, Perth, Western Australia, 6847, Australia; Recruiting

Richard Herrman, MD 61 8 9224 2405

France
Institute Paoli Calmettes, Marseille, 13009, France; Recruiting

Norbert Vey, MD 33 4 91223695

Hopital Beaujon, Clichy, 92110, France; Recruiting

Pierre Fenaux, MD 33 1 40874522 pierre.fenaux@avc.ap-hop-paris.fr

Chu Purpan, Toulouse, 31059, France; Recruiting

Guy Laurent, MD 33 5 61772078

Chu De Nantes, Nantes, 44093, France; Recruiting

Beatrice Mahe, MD 33 2 40083252

Che De Lille, Lille, 59037, France; Recruiting

Bruno Quesnel, MD 33 3 20446640

Hopital Cochin, Paris, 75679, France; Recruiting

Francois Dreyfus, MD 33 1 58412120

Hospital Saint Louis, Paris, 75010, France; Recruiting

Herve Dombret 33 1 42496943 herve.dombret@sls.ap-hop-paris.fr

Germany
Heinrich-Heine University Dusseldorf, Dusseldorf, 40225, Germany; Recruiting

Norbert Gattermann, MD 49 211 811 6500

University Essen, ESSEN, 45147, Germany; Recruiting

Ulrich Duhrsen, DM 49 201 723 2417 ulrich.duhrsen@uni-essen.de

Universitatsklinikum Ulm, Ulm, 89070, Germany; Recruiting

Mathias Schmid, MD 49 731 500 24396

Universitatsklinikum Carl Gustav Carus, Dresden, 1307, Germany; Recruiting

Uwe Platzbecker, MD 49 351 458 4190 uwe.platzbecker@uniklinikum-dresden.de

Klinikum Chemnitz gGmbH, Chemnitz, 9113, Germany; Recruiting

Mathias Hanel, PhD, Dr Med 49 371 333430 Ext. 45 m.haenel@skc.de

St Johannes Hospital, Duisburg, 47166, Germany; Recruiting

Carlo Aul, MD 49 203 546 2480 aul@krebs-duisburg.de

Universitatsklinikum Bonn, Bonn, 53105, Germany; Recruiting

Axel Glasmacher, Ph Dr 49 228 287 Ext. 5507 axel.glasmacher@uk.b.uni-bonn.de

Greece
District General Hospital of Athens, Athens, 11527, Greece; Recruiting

Nikos Anagnostopoulos 30 210 7486796

General Hospital of Chest Disease, Athens, 11527, Greece; Recruiting

Paraskevi Roussou 30 210 7778611

University General Hospital of Ioannina, Ioannina, 45500, Greece; Recruiting

Konstantinos Bourantas 30 26510 99638

University General Hospital of Patra Rio, Patra, 26500, Greece; Recruiting

Nikolaos Zoumbos, MD 30 2610 999247 eskliva@upatras.gr

Greece, Athens
University Hospital-Attikon, Haidari, Athens, 12462, Greece; Recruiting

Vasiliki Pappa 30 210 5831000 vas_pappa@hotmail.com

Greece, Crete
University General Hospital of Heraklio Voutes, Heraklio, Crete, 71110, Greece; Recruiting

Eleni Papadaki 30 2810 392805 epapadak@med.uoc.gr

Italy
Ospedale San Eugenio, Roma, 00144, Italy; Recruiting

Sergio Amadori, MD 39 06 51002504

Centro Oncologico Modenese, Modena, 41100, Italy; Recruiting

Stefano Sacchi, MD 39 59 4222175 ssacchi@unimore.it

Ospedale San Martino, Genova, I-16132, Italy; Recruiting

Andrea Bacigalupo, MD 39 10 355469 andrea.bacigalupo@hsanmartino.liguria.it

Policlinico Gemelli, Roma, 00168, Italy; Recruiting

Giuseppe Leone, MD 39 06 30154180 gleone@rm.unicatt.it

Policlinico S. Orsola-Malpighi, Bologna, 40138, Italy; Recruiting

Michele Baccarani, MD 39 51 390413

Instituto Nazionale Dei Tumori, Milano, 20133, Italy; Recruiting

Paolo Corradini, MD 39 02 23902950 paolo.corradini@unimi.it

Netherlands
Univ Hospital St. Radboud, Nijmejen, Netherlands; Recruiting

Petra Muus 31 24 361 4762 m.bremmers@hemat.umcn.nl

Spain
Hospital Clinic, Barcelona, 08036, Spain; Recruiting

Benet Nomdedeu, MD 34 93 227 55 11 nomdedeu@medicina.ub.es

Hospital Son Llatzer, Palma de Mallorca, 07198, Spain; Recruiting

Joan Bargay, MD 34 871 20 21 38 jbargay@hsll.es

Hospital Universitario Del Salamanca, Salamanca, 37007, Spain; Recruiting

Consuelo Del Canizo, MD 34 923 29 13 84 cocarol@usal.es

Hospital Universitario La Fe, Valencia, 46009, Spain; Recruiting

Miguel Sanz, MD, PhD 34 96 197 30 57 msanz@uv.es

Hospital Santa Creu I Sant Pau, Barcelona, 08025, Spain; Recruiting

Salut Brunet, MD 34 93 291 9396 sbrunet@hsp.santpau.es

Hospital Universitario Germans Trias I Pujol, Barcelona, Spain; Recruiting

Josep Ribera, MD 34 93 497 89 87

Hospital Clinico San Carlos, Madrid, 28048, Spain; Recruiting

Joaquin Diaz-Mediavilla, PhD 34 91 3303312 jdiaz@medynet.com

Sweden
Huddinge University Hospital, Stockholm, 14186, Sweden; Recruiting

Eva Hellstrom-Lindberg, MD, PhD 46 8 58580000 eva.hellstrom-lindberg@medhs.ki.se

Lund Universtiy Hospital, Lund, 22185, Sweden; Recruiting

Lars Nilsson, MD 46 46 170000 Ext. 7416 lars.nilsson@stemcell.lu.se

Sahlgrenska University Hospital, Goteborg, S-413 45, Sweden; Recruiting

Anna Olsson, MD 46 31 342 100 anna.olsson@medic.gu.se

Uppsala University Hospital, Uppsala, S-751 85, Sweden; Recruiting

Gunnar Oberg, MD 46 18 6110000 Ext. 4426 gunnar.oberg@medicin.uas.lul.se

University Hospital MAS, MALMO, S-205 02, Sweden; Recruiting

Jan Astermark, MD 46 40 33 1000 jan.astermark@medforsk.mas.lu.se

United Kingdom
Norfolk and Norwich University Hospital, Norwich, NR4 7UY, United Kingdom; Recruiting

Jane Parker, MD 44 1603 287106 jane.parker@numh.nhs.uk

Kings College Hospital NHS Trust, London, United Kingdom; Recruiting

Graham Mufti, MD 44 020 73463080

Royal Bournemouth General Hospital, Bournemouth, BH7 7DW, United Kingdom; Recruiting

Sally Killick, MD 44 1202 704783 sally.killick@rbch-tr.swest.nhs.uk

St. Bartholomew's Hospital, London, EC1A 7BE, United Kingdom; Recruiting

J Cavenagh, MD 44 20 7882 6029 j.d.cavenagh@gmul.ac.uk

Royal Cornwall Hospital, Truro, TR1 3LJ, United Kingdom; Recruiting

Anton Kruger 44 1865 222 309