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Home > "A" Clinical Trials Conditions > 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
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. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes
2. Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias
3. Efficacy and safety study of CC-5013 monotherapy in subjects with myelodysplastic syndromes
4. Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
5. T-Cell Depletion in Unrelated Donor Marrow Transplantation
Related Studies:
Other Myelodysplastic Syndromes Clinical Trials
Other Western Australia Clinical Trials
Other Perth Clinical Trials
A Survival Study in Patients with High Risk Myelodysplastic Syndromes Comparing Azacitidine versus Conventional Care
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