- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00071799
A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care
A Multicenter, Randomized, Open-label, Parallel-group, Phase 3 Trial of Subcutaneous Azacitidine Plus Best Supportive Care Versus Conventional Care Regimens Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes (MDS)
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). The study will continue for 12 months following last patient enrolled.
See study AZA PH GL 2003 CL 001 E for information about the extension to this study.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Comparison/Control Interventions offered the physician three options:
- Best supportive care (BSC) alone,
- Low-dose cytarabine subcutaneously for 14 days every 28 to 42 days, or
- Standard chemotherapy administered for induction as a continuous intravenous infusion of cytarabine over 7 days plus an anthracycline (daunorubicin, idarubicin, or mitoxantrone) on Days 1, 2, and 3; and, for those eligible, 1 or 2 consolidation cycles administered as continuous intravenous infusions of cytarabine for 3 to 7 days with the same anthracycline that was used at induction on Days 1 and 2 (each cycle between 28 to 70 days from the start of the previous cycle).
All three options included best supportive care. Neither the experimental group (azacitidine) nor any of the comparison/control options allowed use of erythropoietin.
Duration of Intervention: Patients will be treated until death, withdrawal, unacceptable toxicity or conclusion of the study.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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New South Wales
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Liverpool, New South Wales, Australien, 2170
- Liverpool Hospital
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St. Leonards, New South Wales, Australien, 2065
- Royal North Shore Hospital
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Warratah, New South Wales, Australien, 2298
- The Newcastle Mater Miseriecordiae Hospital
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Queensland
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Hersten, Queensland, Australien, 4029
- Royal Brisbane Hospital
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Woolloongabba, Queensland, Australien, 4102
- Princess Alexandra Hospital
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South Australia
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Adelaide, South Australia, Australien, 5000
- Royal Adelaide Hospital
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Victoria
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East Melbourne, Victoria, Australien, 3002
- Peter MacCallum Cancer Institute
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Melbourne, Victoria, Australien, 3050
- Royal Melbourne Hospital
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Melbourne, Victoria, Australien, 3181
- The Alfred Hospital
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Western Australia
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Perth, Western Australia, Australien, 6847
- The Royal Perth Hospital
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Pleven, Bulgarien, 5800
- First Clinical Base - Clinic of Hematology, MHAT - Pleven
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Plovdiv, Bulgarien, 4004
- III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU)
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Plovdiv, Bulgarien, 4002
- MHAT "St George" Clinic of Hematology, Plovdiv
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Sofia, Bulgarien, 1756
- National Centre of Hematology and Transfusiology, Sofia
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Varna, Bulgarien, 9010
- University Multiprofile Hospital for Active Treatment "Sveta Marina"
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Varna, Bulgarien, 3010
- Multiprofile Hospital for Active Treatment (MHAT), "St. Marina" Clinic of Hematology
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Bonn, Deutschland, 53105
- Universitätsklinikum Bonn
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Chemnitz, Deutschland, 9113
- Klinikum Chemnitz gGmbH
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Dresden, Deutschland, 1307
- Universitätsklinikum Carl Gustav Carus
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Duisburg, Deutschland, 47166
- St Johannes Hospital
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Dusseldorf, Deutschland, 40225
- Heinrich-Heine University Düsseldorf
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Essen, Deutschland, 45147
- University Essen
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Gottingen, Deutschland, 37075
- Gerorg-August-Universitat Gottingen
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Hamburg, Deutschland, D-20099
- Allgemeines Krankenhaus St. Georg
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Hamburg, Deutschland, D-20246
- Universitatsklinikum Hambur-Eppendorf
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Kiel, Deutschland, D-24116
- Universitatsklinikum Kiel II
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Ulm, Deutschland, 89070
- Universitätsklinikum Ulm
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Berlin
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Hindenburgdamm, Berlin, Deutschland, D-12203
- Universitatsklinikum Benjamin Franklin
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Angers, Frankreich, 49033
- CHU d'Angers
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Clichy, Frankreich, 92110
- Hopital Beaujon
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Lille, Frankreich, 59037
- Che De Lille
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Lyon, Frankreich, 69437
- Hospital Edouard Herriot
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Marseille, Frankreich, 13009
- Institute Paoli Calmettes
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Nantes, Frankreich, 44093
- CHU de Nantes
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Paris, Frankreich, 75679
- Hopital Cochin
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Paris, Frankreich, 75010
- Hospital Saint Louis
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Rouen, Frankreich, 76038
- Centre Henri Becquerel
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Toulouse, Frankreich, 31059
- Chu Purpan
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Athens, Griechenland, 11527
- District General Hospital of Athens
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Athens, Griechenland, 11527
- General Hospital of Chest Disease
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Ioannina, Griechenland, 45500
- University General Hospital of Ioannina
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Patra, Griechenland, 26500
- University General Hospital of Patra Rio
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Athens
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Haidari, Athens, Griechenland, 12462
- University Hospital-Attikon
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Crete
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Heraklio, Crete, Griechenland, 71110
- University General Hospital of Heraklio Voutes
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Bologna, Italien, 40138
- Policlinico S. Orsola-Malpighi
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Firenze, Italien, 50139
- Universita Di Firenze
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Genova, Italien, I-16132
- Ospedale San Martino
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Milano, Italien, 20133
- Instituto Nazionale Dei Tumori
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Modena, Italien, 41100
- Centro Oncologico Modenese
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Roma, Italien, 00168
- Policlinico Gemelli
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Roma, Italien, 00144
- Ospedale San Eugenio
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Roma, Italien, 144
- Instituto Nazionale Tumori "Regina Elena"
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San Giovanni Rotondo, Italien, 71013
- Ospedale Casa Sollievo Della Sofferenza - Irrc
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Sassari, Italien, 7100
- Università degli Studi di Sassari
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Amsterdam, Niederlande, 1081 HV
- VU University Medical Center Amsterdam
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Nijmejen, Niederlande
- Univ Hospital St. Radboud
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-
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-
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Gdansk, Polen, 80-952
- Samodzielny Publiczny Szpital Kliniczny Nr 1
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Lodz, Polen, 93-510
- Wojewodzki Szpital Specjalistyczny
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Lublin, Polen, 20081
- Samodzielny Publiczny Szpital Kliniczny
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Warszawa, Polen, 00-909
- Wojskowy Instytut Medyczny
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Warszawa, Polen, 02-097
- Samodzelny Publiczny Centralny Szpital Kliniczny
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Wroclaw, Polen, 50-367
- Samodzielny Publiczny Szpital Kliniczny Nr 1
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Moscow, Russische Föderation, 105299
- Burdenko Central Military Clinical Hospital
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Moscow, Russische Föderation, 115487
- Blokhin Cancer Research Center
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Moscow, Russische Föderation, 125167
- Scientific Haematology Center, Moscow
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St. Petersburg, Russische Föderation, 197089
- Pavlov State Medical University
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St. Petersburg, Russische Föderation, 197110
- City Hospital #31
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St. Petersburg, Russische Föderation, 193024
- Institute of Haematology & Blood Transfusion
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St. Petersburg, Russische Föderation, 197022
- Pavlov State Medical University
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Goteborg, Schweden, S-413 45
- Sahlgrenska University Hospital
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Lund, Schweden, 22185
- Lund Universtiy Hospital
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Malmo, Schweden, S-205 02
- University Hospital MAS
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Stockholm, Schweden, 14186
- Huddinge University Hospital
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Uppsala, Schweden, S-751 85
- Uppsala University Hospital
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Barcelona, Spanien, 08036
- Hospital Clínic
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Barcelona, Spanien, 08025
- Hospital Santa Creu i Sant Pau
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Barcelona, Spanien
- Hospital Universitario Germans Trias i Pujol
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Leon, Spanien, 24071
- Hospital de Leon
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Madrid, Spanien, 28006
- Hospital Universitario de La Princesa
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Madrid, Spanien, 28034
- Hospital Ramón y Cajal
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Madrid, Spanien, 28046
- Hospital La Paz, Madrid
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Madrid, Spanien, 28048
- Hospital Clinico San Carlos
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Palma de Mallorca, Spanien, 07198
- Hospital Son Llàtzer
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Salamanca, Spanien, 37007
- Hospital Universitario Del Salamanca
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Valencia, Spanien, 46009
- Hospital Universitario La Fe
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Olomouc, Tschechien, 775 20
- Fakultni nemocnice Olomouc
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Praha, Tschechien, 2 128 08
- Vseobecna fakultni nemocnice
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Praha, Tschechien, 2 128 20
- Uslav Hematologie a Krevni Transfuze
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Brno
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Jihlavska, Brno, Tschechien, 639 00
- Fakultni nemocnice Brno
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Hradec Kralove
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Sokolska, Hradec Kralove, Tschechien, 500 05
- Fakultni nemocnice Hradec Kralove
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Budapest, Ungarn, 1135
- Orszagos Gyogyintezeti Kozpont
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Pecs, Ungarn, 7624
- University of Pecs, 1st Dept of Internal Medicine
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Szeged, Ungarn, 6701
- University of Szeged, 2nd Department of Internal Medicine
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35294
- University of Alabama School of Medicine
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Indiana
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Indianapolis, Indiana, Vereinigte Staaten, 46202
- Indiana University Cancer Center
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Missouri
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Saint Louis, Missouri, Vereinigte Staaten, 63110
- Washington University School of Medicine
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New York
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New York, New York, Vereinigte Staaten, 10029-6574
- Mount Sinai Medical Center
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Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44106
- Case Western Reserve University
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Oregon
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Portland, Oregon, Vereinigte Staaten, 97201
- Oregon Cancer Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15224
- Western Pennsylvania Cancer Institute
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Wisconsin
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Milwaukee, Wisconsin, Vereinigte Staaten, 53226
- Froedtert Memorial Lutheran Hospital
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Bournemouth, Vereinigtes Königreich, BH7 7DW
- Royal Bournemouth General Hospital
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London, Vereinigtes Königreich, EC1A 7BE
- St. Bartholomew's Hospital
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London, Vereinigtes Königreich
- Kings College Hospital NHS Trust
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Manchester, Vereinigtes Königreich, M20 4BX
- Christie Hospital
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Norwich, Vereinigtes Königreich, NR4 7UY
- Norfolk and Norwich University Hospital
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Oxford, Vereinigtes Königreich, OX3 9DU
- John Radcliffe Hospital
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Truro, Vereinigtes Königreich, TR1 3LJ
- Royal Cornwall Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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 myelodysplastic syndromes (MDS) and a relatively high risk of acute myeloid leukemia (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 myelodysplastic syndromes (MDS)
- Prior treatment with azacitidine;
- Prior history of acute myeloid leukemia (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;
- Within the 28-day screening period, documented red cell folate deficiency, as evidenced by red blood cell folate (not serum folate) or vitamin B12 deficiency
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Azacitidine
Study Drug plus best supportive care.
Treatment with erythropoietin was not permitted
|
Azacitidine was injected subcutaneously (SC) at an initial dose of 75mg/m^2/day for 7 days.
The 7-day dosing was repeated every 28 days with dose adjustment based on predefined hematology and renal laboratory results.
Number of cycles: Azacitidine treatment was to be continued until the end of the study unless treatment was discontinued due to unacceptable toxicity, relapse after complete or partial response, transformation to AML or disease progression.
Andere Namen:
|
Aktiver Komparator: Conventional Care
Physician choice of low dose cytarabine (plus best supportive care), standard chemotherapy (plus best supportive care) or best supportive care (only).
Treatment with erythropoietin was not permitted
|
Physician Choice was one of three options:
All three options included best supportive care
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Kaplan-Meier Estimates for Median Time to Death From Any Cause
Zeitfenster: Day 1 (randomization) to 42 months
|
Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population.
Patients surviving at the end of the follow-up period were censored at the date of last contact.
If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.
|
Day 1 (randomization) to 42 months
|
Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause
Zeitfenster: Day 1 (randomization) to 42 months
|
Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact. Subgroups that were analyzed are age, gender, French-American-British (FAB) classification, World Health Organization (WHO) classification and International Prognostic Scoring System (IPSS) classification. |
Day 1 (randomization) to 42 months
|
Number of Participants Who Died
Zeitfenster: 42 months
|
Count of participants who died during the study
|
42 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Kaplan-Meier Estimate for Median Time to Transformation to Acute Myeloid Leukemia (AML) or Death From Any Cause, Whichever Occurred First
Zeitfenster: Day 1 (randomization) to 42 months
|
The time to transformation to AML or death from any cause (whichever occurred first) was defined as the number of days from the date of randomization until the date of documented AML transformation or death from any cause.
Patients who did not transform to AML or die were censored at the date of last follow-up.
|
Day 1 (randomization) to 42 months
|
Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML)
Zeitfenster: Day 1 (randomization) to 42 months
|
The time to transformation to AML was defined as the number of days from the date of randomization until the date of documented AML transformation, defined as a bone marrow blast count ≥ 30% independent of baseline bone marrow count.
Patients who did not transform to AML were censored at the date of last follow-up or date of death.
|
Day 1 (randomization) to 42 months
|
Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline
Zeitfenster: Day 1 (randomization) to 42 months
|
Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were dependent at baseline.
A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization.
During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more.
Otherwise, the patient was considered transfusion dependent.
|
Day 1 (randomization) to 42 months
|
Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Independent at Baseline
Zeitfenster: Day 1 (randomization) to 42 months
|
Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were independent at baseline.
A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization.
During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more.
Otherwise, the patient was considered transfusion dependent.
|
Day 1 (randomization) to 42 months
|
Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Dependent at Baseline
Zeitfenster: Day 1 (randomization) to 42 months
|
Summary of dependence and independence from platelet transfusion at baseline and during treatment for patients who were dependent at baseline.
A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization.
During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more.
Otherwise, the patient was considered transfusion dependent.
|
Day 1 (randomization) to 42 months
|
Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Independent at Baseline
Zeitfenster: Day 1 (randomization) to 42 months
|
Summary of dependence and independence from platelet transfusion at baseline and during treatment for patients who were independent at baseline.
A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization.
During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more.
Otherwise, the patient was considered transfusion dependent.
|
Day 1 (randomization) to 42 months
|
Number of Participants Considered Hematologic Responders by Investigator Determinations Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS)
Zeitfenster: Day 1 to 42 months
|
Investigator determined responses followed IWG criteria for
|
Day 1 to 42 months
|
Number of Participants Showing Hematologic Improvement Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS) Assessed by Independent Review Committee
Zeitfenster: Day 1 to 42 months
|
IWG 2000 Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L. Erythroid response: Major->20g/L increase or transfusion independent. Minor- 10-20g/L increase or >=50% decrease in transfusion requirements. Platelet response: Major-absolute increase of >=30x10^9/L or platelet transfusion independence. Minor->=50% increase. Neutrophil response: Major->=100% increase or an absolute increase of >0.5x10^9/L. Minor->=100% increase and absolute increase of <0.5x10^9/L. |
Day 1 to 42 months
|
Time to Disease Progression, Relapse After Complete or Partial Remission, or Death From Any Cause
Zeitfenster: Day 1 (randomization) to 42 months
|
The time to disease progression, relapse after complete or partial remission (CR, PR), or death from any cause was defined as the time from the date of randomization until the first date of documented disease progression, relapse after CR or PR, or death from any cause.
|
Day 1 (randomization) to 42 months
|
Duration of Any Hematologic Improvement
Zeitfenster: Day 1 (randomization) to 42 months
|
The duration of improvement was defined as the time from the date of hematologic improvement until the date of first documented progression or relapse after hematologic improvement or death from any cause.
|
Day 1 (randomization) to 42 months
|
Number of Infections Per Treatment Year Requiring Intravenous Antibiotics, Antifungals or Antivirals
Zeitfenster: Day 1 (randomization) to 42 months
|
The on-treatment adverse event rate of infection requiring IV antibiotics, antifungals, or antivirals per patient-years.
The on-treatment period was considered the period from the date of randomization to the last treatment study visit.
|
Day 1 (randomization) to 42 months
|
Number of Participants in Different Categories of Adverse Experiences During Core Study Period
Zeitfenster: Day 1 (randomization) to 42 months
|
Patient counts for a variety of subsets of adverse experiences for the core study period (day 1 to 42 months).
The individual options for Conventional Care Regimens (Best Supportive Care Only, Low-Dose Cytarabine, and Standard Chemotherapy) are presented as separate treatments.
|
Day 1 (randomization) to 42 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: CL Beach, Celgene Corporation
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Fenaux P, Mufti GJ, Hellstrom-Lindberg E, Santini V, Finelli C, Giagounidis A, Schoch R, Gattermann N, Sanz G, List A, Gore SD, Seymour JF, Bennett JM, Byrd J, Backstrom J, Zimmerman L, McKenzie D, Beach C, Silverman LR; International Vidaza High-Risk MDS Survival Study Group. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol. 2009 Mar;10(3):223-32. doi: 10.1016/S1470-2045(09)70003-8. Epub 2009 Feb 21.
- Fenaux P, Mufti GJ, Hellstrom-Lindberg E, Santini V, Gattermann N, Germing U, Sanz G, List AF, Gore S, Seymour JF, Dombret H, Backstrom J, Zimmerman L, McKenzie D, Beach CL, Silverman LR. Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia. J Clin Oncol. 2010 Feb 1;28(4):562-9. doi: 10.1200/JCO.2009.23.8329. Epub 2009 Dec 21.
- Fenaux P, Gattermann N, Seymour JF, Hellstrom-Lindberg E, Mufti GJ, Duehrsen U, Gore SD, Ramos F, Beyne-Rauzy O, List A, McKenzie D, Backstrom J, Beach CL. Prolonged survival with improved tolerability in higher-risk myelodysplastic syndromes: azacitidine compared with low dose ara-C. Br J Haematol. 2010 Apr;149(2):244-9. doi: 10.1111/j.1365-2141.2010.08082.x. Epub 2010 Feb 5. Erratum In: Br J Haematol. 2010 Jun;149(6):919.
- Santini V, Fenaux P, Mufti GJ, Hellstrom-Lindberg E, Silverman LR, List A, Gore SD, Seymour JF, Backstrom J, Beach CL. Management and supportive care measures for adverse events in patients with myelodysplastic syndromes treated with azacitidine*. Eur J Haematol. 2010 Aug;85(2):130-8. doi: 10.1111/j.1600-0609.2010.01456.x. Epub 2010 Apr 12.
- Seymour JF, Fenaux P, Silverman LR, Mufti GJ, Hellstrom-Lindberg E, Santini V, List AF, Gore SD, Backstrom J, McKenzie D, Beach CL. Effects of azacitidine compared with conventional care regimens in elderly (>/= 75 years) patients with higher-risk myelodysplastic syndromes. Crit Rev Oncol Hematol. 2010 Dec;76(3):218-27. doi: 10.1016/j.critrevonc.2010.04.005. Epub 2010 May 6.
- Gore SD, Fenaux P, Santini V, Bennett JM, Silverman LR, Seymour JF, Hellstrom-Lindberg E, Swern AS, Beach CL, List AF. A multivariate analysis of the relationship between response and survival among patients with higher-risk myelodysplastic syndromes treated within azacitidine or conventional care regimens in the randomized AZA-001 trial. Haematologica. 2013 Jul;98(7):1067-72. doi: 10.3324/haematol.2012.074831. Epub 2013 Apr 12.
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Neubildungen
- Erkrankung
- Erkrankungen des Knochenmarks
- Hämatologische Erkrankungen
- Krebsvorstufen
- Syndrom
- Myelodysplastische Syndrome
- Präleukämie
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Enzym-Inhibitoren
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Azacitidin
- Cytarabin
Andere Studien-ID-Nummern
- AZA PH GL 2003 CL001
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Myelodysplastische Syndrome
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University of Colorado, DenverRekrutierungKlinefelter-Syndrom | Trisomie X | XYY-Syndrom | XXXY- und XXXXY-Syndrom | Xxyy-Syndrom | Xyyy-Syndrom | Xxxx-Syndrom | Xxxxx-Syndrom | Xxxyy-Syndrom | Xxyyy-Syndrom | Xyyyy-Syndrom | Männchen mit GeschlechtschromosomenmosaikVereinigte Staaten
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Riphah International UniversityAbgeschlossen
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Riphah International UniversityAbgeschlossen
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Shaare Zedek Medical CenterUnbekanntPrämenstruelles Syndrom-PMS
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Esra ÖZERKTO Karatay UniversityRekrutierungPrämenstruelles Syndrom-PMSTruthahn
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Assistance Publique - Hôpitaux de ParisRekrutierungIntensivstation-Syndrom | Pädiatrisches Post-Intensivpflege-SyndromFrankreich
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Riphah International UniversityRekrutierungUpper-Cross-SyndromPakistan
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Cairo UniversityNoch keine Rekrutierung
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Cairo UniversityRekrutierung
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Riphah International UniversityAbgeschlossenUpper-Cross-SyndromPakistan
Klinische Studien zur Azacitidine
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Shandong Provincial HospitalUnbekanntMyelodysplastische Syndrome, akute myeloische LeukämieChina
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TJ Biopharma Co., Ltd.Rekrutierung
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Peter MacCallum Cancer Centre, AustraliaGlaxoSmithKline; Celgene CorporationAbgeschlossenMyelodysplastische Syndrome (MDS) | Akute myeloische Leukämie (AML)Australien
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Navy General Hospital, BeijingRekrutierungRefraktäres klassisches Hodgkin-Lymphom | Rezidiviertes klassisches Hodgkin-LymphomChina
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Nanexa ABUppsala UniversityAbgeschlossenMyelodysplastische Syndrome (MDS) | Akute myeloische Leukämie (AML) | Chronische myelomonozytäre Leukämie (CMML)Schweden
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CelgeneAbgeschlossenMyelodysplastische Syndrome (MDS) | Chronische myelomonozytäre Leukämie (CMML) | Akute myeloische Leukämie (AML)Vereinigte Staaten
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University of BirminghamRekrutierungAkute myeloische Leukämie | MyelodysplasieVereinigtes Königreich
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Bristol-Myers SquibbRekrutierungMyelodysplastische SyndromeVereinigte Staaten, Japan, Argentinien, Hongkong, Griechenland, Italien, China, Australien, Spanien, Österreich, Dänemark, Deutschland, Schweden, Schweiz, Kanada, Tschechien, Korea, Republik von, Polen, Truthahn, Frankreich
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Groupe Francophone des MyelodysplasiesMerck Sharp & Dohme LLCBeendetMyelodysplastisches SyndromFrankreich
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Grupo Cooperativo de Hemopatías MalignasZurückgezogenAkute myeloische Leukämie | Myelodysplastische SyndromeMexiko