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



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

For Condition: Myelodysplastic Syndromes
Status: Recruiting
Sponsor(s): Pharmion ,
Synopsis: 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).
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

District General Hospital of Athens *Recruiting*
Athens,  ,  11527
Greece
Recruiting Nikos  Anagnostopoulos 30 210 7486796

Chu Purpan *Recruiting*
Toulouse,  ,  31059
France
Recruiting Guy  Laurent 33 5 61772078

Chu De Nantes *Recruiting*
Nantes,  ,  44093
France
Recruiting Beatrice  Mahe 33 2 40083252

Royal Melbourne Hospital *Recruiting*
Melbourne,  Victoria,  3050
Australia
Recruiting Jeff  Szer 61 3 9342 7737

Royal Brisbane Hospital *Recruiting*
Hersten,  Queensland,  4029
Australia
Recruiting Simon  Durrant 61 7 3636 1340

University Hospital MAS *Recruiting*
MALMO,  ,  S-205 02
Sweden
Recruiting Jan  Astermark 46 40 33 1000

The Alfred Hospital *Recruiting*
Melbourne,  Victoria,  3181
Australia
Recruiting Andrew  Spencer 61 3 9276 3392

Uppsala University Hospital *Recruiting*
Uppsala,  ,  S-751 85
Sweden
Recruiting Gunnar  Oberg 46 18 6110000

Case Western Reserve University *Recruiting*
Cleveland,  Ohio,  44106
United States
Recruiting Donna  Kane 216-844-8609

Western Pennsylvania Cancer Institute *Recruiting*
Pittsburgh,  Pennsylvania,  15224
United States
Recruiting Michelle  Marietti 412-578-5346

Oregon Cancer Center *Recruiting*
Portland,  Oregon,  97201
United States
Recruiting Peter  Curtin 503-494-5064

Hospital Clinic *Recruiting*
Barcelona,  ,  08036
Spain
Recruiting Benet  Nomdedeu 34 93 227 55 11

University General Hospital of Patra Rio *Recruiting*
Patra,  ,  26500
Greece
Recruiting Nikolaos  Zoumbos 30 2610 999247

Ospedale San Eugenio *Recruiting*
Roma,  ,  00144
Italy
Recruiting Sergio  Amadori 39 06 51002504

Hospital Santa Creu I Sant Pau *Recruiting*
Barcelona,  ,  08025
Spain
Recruiting Salut  Brunet 34 93 291 9396

Mount Sinai Medical Center *Recruiting*
New York City,  New York,  10029-6574
United States
Recruiting Lewis  Silverman 212-241-6021

Hopital Cochin *Recruiting*
Paris,  ,  75679
France
Recruiting Francois  Dreyfus 33 1 58412120

Hopital Beaujon *Recruiting*
Clichy,  ,  92110
France
Recruiting Pierre  Fenaux 33 1 40874522

Centro Oncologico Modenese *Recruiting*
Modena,  ,  41100
Italy
Recruiting Stefano  Sacchi 39 59 4222175

Froedtert Memorial Lutheran Hospital *Recruiting*
Milwaukee,  Wisconsin,  53226
United States
Recruiting David  Vesole 414-805-4629

Huddinge University Hospital *Recruiting*
Stockholm,  ,  14186
Sweden
Recruiting Eva  Hellstrom-Lindberg 46 8 58580000

University General Hospital of Ioannina *Recruiting*
Ioannina,  ,  45500
Greece
Recruiting Konstantinos  Bourantas 30 26510 99638

Royal Adelaide Hospital *Recruiting*
Adelaide,  South Australia,  5000
Australia
Recruiting Noemi  Horvath 61 8 8222 3550

Universitatsklinikum Ulm *Recruiting*
Ulm,  ,  89070
Germany
Recruiting Mathias  Schmid 49 731 500 24396

Che De Lille *Recruiting*
Lille,  ,  59037
France
Recruiting Bruno  Quesnel 33 3 20446640

University Essen *Recruiting*
ESSEN,  ,  45147
Germany
Recruiting Ulrich  Duhrsen 49 201 723 2417

The Royal Perth Hospital *Recruiting*
Perth,  Western Australia,  6847
Australia
Recruiting Richard  Herrman 61 8 9224 2405

General Hospital of Chest Disease *Recruiting*
Athens,  ,  11527
Greece
Recruiting Paraskevi  Roussou 30 210 7778611

Sahlgrenska University Hospital *Recruiting*
Goteborg,  ,  S-413 45
Sweden
Recruiting Anna  Olsson 46 31 342 100

Kings College Hospital NHS Trust *Recruiting*
London,  , 
United Kingdom
Recruiting Graham  Mufti 44 020 73463080

Norfolk and Norwich University Hospital *Recruiting*
Norwich,  ,  NR4 7UY
United Kingdom
Recruiting Jane  Parker 44 1603 287106

University General Hospital of Heraklio Voutes *Recruiting*
Heraklio,  Crete,  71110
Greece
Recruiting Eleni  Papadaki 30 2810 392805

Heinrich-Heine University Dusseldorf *Recruiting*
Dusseldorf,  ,  40225
Germany
Recruiting Norbert  Gattermann 49 211 811 6500

Indiana University Cancer Center *Recruiting*
Indianapolis,  Indiana,  46202
United States
Recruiting Larry  Cripe 317-274-3545

Hospital Universitario La Fe *Recruiting*
Valencia,  ,  46009
Spain
Recruiting Miguel  Sanz 34 96 197 30 57

Peter MacCallum Cancer Institute *Recruiting*
East Melbourne,  Victoria,  3002
Australia
Recruiting John  Seymour 61 3 9 656 1700

Lund Universtiy Hospital *Recruiting*
Lund,  ,  22185
Sweden
Recruiting Lars  Nilsson 46 46 170000

University of Alabama School of Medicine *Recruiting*
Birmingham,  Alabama,  35294
United States
Recruiting Peter  Emanuel 205-934-6195

The Newcastle Mater Miseriecordiae Hospital *Recruiting*
Warratah,  New South Wales,  2298
Australia
Recruiting Arno  Enno 61 2 4921 1215

Hospital Universitario Del Salamanca *Recruiting*
Salamanca,  ,  37007
Spain
Recruiting Consuelo  Canizo 34 923 29 13 84

Liverpool Hospital *Recruiting*
Liverpool,  New South Wales,  2170
Australia
Recruiting John  Gallo 61 2 828 5167

Hospital Son Llatzer *Recruiting*
Palma de Mallorca,  ,  07198
Spain
Recruiting Joan  Bargay 34 871 20 21 38

Princess Alexandra Hospital *Recruiting*
Woolloongabba,  Queensland,  4102
Australia
Recruiting Anthony  Mills 61 7 3240 2086

Washington University School of Medicine *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Alisa  Ruddell 314-454-5095

Institute Paoli Calmettes *Recruiting*
Marseille,  ,  13009
France
Recruiting Norbert  Vey 33 4 91223695


Additional Information:
Study ID Numbers:
  AZA PH GL 2003 CL 001; 
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071799

Other Myelodysplastic Syndromes Studies:
1. Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes

2. Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic Syndrome

3. Cord Blood Stem Cell Transplantation Study (COBLT)

4. Blood and Marrow Transplant Clinical Research Network

5. Interleukin-2 in Treating Patients With Myelodysplastic Syndrome

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