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Conventional Medicine |
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Clinical Trial: A Survival Study in Patients with High Risk Myelodysplastic Syndromes Comparing Azacitidine versus Conventional Care
This study is currently recruiting patients.
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Purpose
The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes (MDS) treated with azacitidine have improved survival compared to conventional care treatments. The study will also assess the effect of treatments on response, duration of response, and transformation to acute myeloid leukemia (AML).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Myelodysplastic Syndromes | Drug: Azacitidine | Phase III |
MedlinePlus related topics: Bone Marrow Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Further Study Details:
Primary Outcomes: Survival
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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.
Location and Contact Information
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
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
Bulgaria
Multiprofile Hospital for Active Treatment (MHAT), "St. Marina" Clinic of Hematology, Varna, 3010, Bulgaria; Recruiting
Liana Gercheva 359 359 52302935 kyuchger@mail.vega.bg
MHAT "St George" Clinic of Hematology, Plovdiv, Plovdiv, 4002, Bulgaria; Recruiting
Stefcho Goranov, MD 359 32 60 24 81
National Centre of Hematology and Transfusiology, Sofia, Sofia, 1756, Bulgaria; Recruiting
Dontcho Peytchev, MD, PhD 359 2 970 1154 dontchob@tea.bg
First Clinical Base - Clinic of Hematology, MHAT - Pleven, Pleven, 5800, Bulgaria; Recruiting
Nikolay Tzvetkov, MD 359 64 42 73 92
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
Centre Henri Becquerel, Rouen, 76038, France; Recruiting
Aspasia Stamatoullas, MD 33 2 32 08 22 23 Ext. 332
Hospital Edouard Herriot, Lyon, 69437, France; Recruiting
Eric Wattel, MD 34 4 787851 Ext. 15 wattel@lyon.fncicc.fr
Chu D'Angers, Angers, 49033, France; Recruiting
Mathilde Hunault-Berger, M.D. 33 241 3544 Ext. 75 mahunault@chu-angers.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
Aristoteles Giagouinidis, MD 49 203 546 2480
Universitatsklinikum Bonn, Bonn, 53105, Germany; Recruiting
Axel Glasmacher, Ph Dr 49 228 287 Ext. 5507 axel.glasmacher@uk.b.uni-bonn.de
Gerorg-August-Universitat Gottingen, Gottingen, 37075, Germany; Recruiting
Detlef Haase, PhD Dr med 49 551 39 8535 haase.onkologie@med.uni-goettingen.de
Universitatsklinikum Hambur-Eppendorf, Hamburg, D-20246, Germany; Recruiting
Walter Fiedler, Prof Dr med 49 40 42803 Ext. 39880 fiedler@uke.uni-hamburg.de
Universitatsklinikum Kiel II, Kiel, D-24116, Germany; Recruiting
Heinz Horst, Pd Dr. 49 431 1697
Allgemeines Krankenhaus St. Georg, Hamburg, D-20099, Germany; Recruiting
Norbert Schmitz, Prof Dr 49 40 2830
Germany, Berlin
Universitatsklinikum Benjamin Franklin, Hindenburgdamm, Berlin, D-12203, Germany; Recruiting
Wolf Hoffman, Dr. med 49-30-8445 Ext. 5903
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
Universita di Firenze, Firenze, 50139, Italy; Recruiting
Alberto Bosi, MD 39 055 4277 Ext. 276
Universita Degli Studi Di Sassari, Sassari, 7100, Italy; Recruiting
Maurizio Longinotti, MD 39 079 228282 longinot@uniss.it
Instituto Nazionale Tumori "Regina Elena", Roma, 144, Italy; Recruiting
Maria Concetta Petti, MD 39 06 52665685 mcpetti@ifo.it
Ospedale Casa Sollievo Della Sofferenza - Irrc, San Giovanni Rotondo, 71013, Italy; Recruiting
Musto Pellegrino, MD 39 0882 410 Ext. 539
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
Hospital de Leon, Leon, 24071, Spain; Recruiting
Fernando Ramos y Ortega, MD, PhD 34 987 23 74 00
Hospital Universitario De La Princesa, Madrid, 28006, Spain; Recruiting
Angela Figuera Alvarez, PhD 34 91 5202354 hematologia@hup.es
Hospital La Paz, Madrid, Madrid, 28046, Spain; Recruiting
Miguel Canales 34 91 7277116 mcanales.hulp@salud.madrid.org
Hospital Ramon Y Cajal, Madrid, 28034, Spain; Recruiting
Jaime Perez de Oteyza, MD, PhD 34 91 3368362
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
More Information
Study ID Numbers: AZA PH GL 2003 CL 001
Record last reviewed: March 2005
Last Updated: April 4, 2005
Record first received: October 31, 2003
ClinicalTrials.gov Identifier: NCT00071799
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: March 2005
Last Updated: April 4, 2005
Record first received: October 31, 2003
ClinicalTrials.gov Identifier: NCT00071799
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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