Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)
NCT ID: NCT01074047
Last Updated: 2017-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
488 participants
INTERVENTIONAL
2010-06-01
2016-07-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Azacitidine
Azacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
Azacitidine
75 mg/m\^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
Conventional Care Regimen
Conventional Care Regimen
Conventional Care Regimen
Physician pre-selects prior to randomization from one of the following:
* Intensive chemotherapy (cytarabine 100-200 mg/m\^2 continuous intravenous infusion for 7 days + anthracycline IV x 3 days) + Best Supportive Care; induction with up to 2 consolidation cycles
* Low-dose cytarabine 20 mg subcutaneous (SC) twice a day (BID) for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity
* Best Supportive Care only; until study end
Interventions
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Azacitidine
75 mg/m\^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
Conventional Care Regimen
Physician pre-selects prior to randomization from one of the following:
* Intensive chemotherapy (cytarabine 100-200 mg/m\^2 continuous intravenous infusion for 7 days + anthracycline IV x 3 days) + Best Supportive Care; induction with up to 2 consolidation cycles
* Low-dose cytarabine 20 mg subcutaneous (SC) twice a day (BID) for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity
* Best Supportive Care only; until study end
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed de novo acute myeloid leukemia (AML)
* AML secondary to myelodysplastic syndromes (MDS)
* AML secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years
* Bone marrow blasts \>30%
* Age ≥ 65 years
* Easter Cooperative Oncology Group (ECOG) 0-2
Exclusion Criteria
* Previous treatment with azacitidine, decitabine or cytarabine
* Prior use of targeted therapy agents (e.g., FLT3 inhibitors, other kinase inhibitors)
* AML French American British subtype (FAB M3)
* AML associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes
* Prior bone marrow or stem cell transplantation
* Candidate for allogeneic bone marrow or stem cell transplant
* Diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure)
* Malignant hepatic tumors
* Uncontrolled systemic infection
* Active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis type B or C
* Use of any experimental drug or therapy within 28 days prior to Day 1
65 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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C L Beach, PharmD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
MD Anderson Cancer Center
Houston, Texas, United States
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
St Vincent's Hospital
Fitzroy, , Australia
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, Austria
Wilhelminenspital, I Medizinische Abt.
Vienna, Vienna, Austria
Landeskliniken Salzburg Saint Johanns-Spital, III Medizinische Abteilung
Salzburg, , Austria
Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Namur, Belgium
Universitair Ziekenhuis Gent
Ghent, Oost-vlaanderen, Belgium
Algemeen Ziekenhuis Sint-Jan
Bruges, West-vlaanderen, Belgium
Centre Hospitalier de Jolimont-Lobbes
La Louvière, , Belgium
University of Alberta Hospital
Edmonton, Alberta, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Ottawa Hospital General Campus
Ottawa, Ontario, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal pavilion Notre Dame
Montreal, Quebec, Canada
Hopital du Sacre Coeur de Montréal
Montreal, Quebec, Canada
Tom Baker Cancer Centre
Calgary, , Canada
Princess Margaret Hospital
Ontario, , Canada
The Third Hospital of Peking University
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Peoples Hospital of Jiangsu Province
Jiangsu, , China
Shanghai Ruijin Hospital
Shanghai, , China
Shanghai Changhai Hospital,the Second Military Medical University
Shanghai, , China
West China Hospital,Sichuan University
Sichuan, , China
Tianjin Blood Disease Hospital
Tianjin, , China
Fakultni nemocnice Brno
Brno, Jihormoravsky Kraj, Czechia
Fakultni nemocnice Olomouc, hemato-onkologicka klinika
Olomouc, Olomoucký kraj, Czechia
Vseobecna Fakultni Nemocnice v Praze
Prague, Prague, Czechia
Ustav hematologie a krevni transfuze
Prague, Prague, Czechia
Centre Hospitalier Régional Universitaire, Hôpital de Hautepierre
Strasbourg, Alsace, France
Centre Hopitalier Universitaire Dupuytren
Limoges, Limousin Lorraine, France
Centre Hospitalier Universitaire de Toulouse
Toulouse, Midi-pyrénées, France
Centre Hospitalier Universitaire de Nice
Nice, Nice, France
CHRU d'Angers
Angers, Pays de la Loire Region, France
Centre Hospitalier Universitaire Nantes, Hotel Dieu
Nantes, Pays de la Loire Region, France
Centre Hospitalier Universitaire d'Amiens, Groupe Hospitalier Sud
Amiens, Picardie, France
Hôpital de la Conception
Marseille, Provence-Alpes-Côte d'Azur Region, France
Centre Hospitalier de la Cote Basque
Aquitaine, , France
Centre Hospitalier Universitaire de Lyon-Hôpital Edouard Herriot
Lyon, , France
Hospital Avicenne, Service d'hematologie Clinique
Bobigny, Île-de-France Region, France
Hopital Percy Clamart
Clamart, Île-de-France Region, France
Hôpital Saint Louis
Paris, Île-de-France Region, France
Universitatsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
University of Rostock, Div. of Haematology and Oncology
Rostock, Mecklenburg-Vorpommern, Germany
Universitatsklinikum Essen, Zentrum fur Tumorforschung und Tumortherapie
Essen, Nordrhein-Westfallen, Germany
Heinrich-Heine-Universität Düsseldorf
Düesseldorf, North Rhine-Westphalia, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Soroka Medical Center
Beersheba, Beersheva, Israel
Assaf Harofeh Medical Centre
Beer Yaakov, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Chaim Sheba Medical Center - Tel Hashomer, Heart Institute
Tel Litwinsky, , Israel
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
Rionero in Vulture, Potenza, Italy
Azienda Sanitaria Ospedaliera "San Luigi Gonzaga"
Orbassano, Turin, Italy
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
Alessandria, , Italy
Azienda Ospedaliera Universitaria - Ospedali Riuniti di Ancona
Ancona, , Italy
Azienda Ospedaliera Policlinico di Bari
Bari, , Italy
Azienda Ospedaliera Sant'Orsola Malpighi
Bologna, , Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Reggio Calabria, , Italy
Azienda Policlinico Umberto I di Roma
Roma, , Italy
Policlinico Universitario Agostino Gemelli
Roma, , Italy
Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine
Udine, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
Wroclaw, Lower Silesian Voivodeship, Poland
Dolnoslaskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
Wroclaw, Lower Silesian Voivodeship, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, Masovian Voivodeship, Poland
Samodzielny Publiczny SK im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, Silesian Voivodeship, Poland
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
Lódz, Łódź Voivodeship, Poland
City Clinical Hospital n.a. S. P. Botkin
Moscow, , Russia
State Healthcare Institution "Nizhny Novgorod N.A. Semashko Regional Clinical Hospital"
Nizhny Novgorod, , Russia
Saint Petersburg State Academician I.P. Pavlov Medical University
Saint Petersburg, , Russia
Saratov State Medical University
Saratov, , Russia
Central City Hospital # 7
Yekaterinburg, , Russia
Samsung Medical Center
Gangnam-gu, Seoul, South Korea
Seoul National University Hospital
Jongno-gu, Seoul, South Korea
Yonsei University Health System
Seodaemun-gu, Seoul, South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Seoul Saint Mary's Hospital Seocho-gu
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Hospital at Guro
Seoul, , South Korea
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, Spain
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Chang Gung Memorial Hospital, Kaohsiung
Niao-Sung Hsiang, Kaohsiung, Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital Pei-Tou District
Taipei, , Taiwan
Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Barts and the London NHS Trust
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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References
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Seymour JF, Dohner H, Butrym A, Wierzbowska A, Selleslag D, Jang JH, Kumar R, Cavenagh J, Schuh AC, Candoni A, Recher C, Sandhu I, Del Castillo TB, Al-Ali HK, Falantes J, Stone RM, Minden MD, Weaver J, Songer S, Beach CL, Dombret H. Azacitidine improves clinical outcomes in older patients with acute myeloid leukaemia with myelodysplasia-related changes compared with conventional care regimens. BMC Cancer. 2017 Dec 14;17(1):852. doi: 10.1186/s12885-017-3803-6.
Dombret H, Seymour JF, Butrym A, Wierzbowska A, Selleslag D, Jang JH, Kumar R, Cavenagh J, Schuh AC, Candoni A, Recher C, Sandhu I, Bernal del Castillo T, Al-Ali HK, Martinelli G, Falantes J, Noppeney R, Stone RM, Minden MD, McIntyre H, Songer S, Lucy LM, Beach CL, Dohner H. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015 Jul 16;126(3):291-9. doi: 10.1182/blood-2015-01-621664. Epub 2015 May 18.
Other Identifiers
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AZA-AML-001
Identifier Type: -
Identifier Source: org_study_id
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