Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)

NCT01074047 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: AZA-AML-001
• Study Type: interventional
• Target: 488
• Locations: 17 countries
• Sites: 106

Brief Summary

The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; Cytarabine; Vidaza; azacitidine; Intensive Chemotherapy; Low Dose Cytarabine; Celgene

Outcome Measures

Primary Outcomes (1)

• Kaplan-Meier Estimates for Overall Survival

  Overall Survival was defined as the time from randomization to death from any cause. Overall survival was calculated by the formula: date of death - date of randomization + 1. Participants surviving at the end of the follow-up period or who withdrew consent to follow-up were censored at the date of last contact. Participants who were lost to follow-up were censored at the date last known alive.

  Day 1 (randomization) to 40 months

Secondary Outcomes (32)

• One-year Overall Survival Rate

  From Day 1 (randomization) to 40 months

• Event-free Survival (EFS)

  Day 1 (randomization) to date of treatment failure, progressive disease, relapse after Complete Remission (CR) or Complete remission with incomplete blood count recovery (CRi), death from any cause. Day 1 (randomization) to 40 months

• Relapse-Free Survival (RFS) for Participants Who Achieved a Complete Remission (CR) or Complete Remission With Incomplete Blood Count Recovery (CRi)

  Day 1 of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up. Day 1 (randomization) to 40 months

• Percentage of Participants Who Achieved a Morphologic CR + CRi as Determined by the Independent Review Committee (IRC) Based on International Working Group (IWG) Response Criteria for Acute Myeloid Leukemia (AML)

  Day 1 (randomization) to 40 months

• Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates

  Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.

Study Arms (2)

Azacitidine

EXPERIMENTAL

Azacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity

Drug: Azacitidine

Conventional Care Regimen

ACTIVE COMPARATOR

Conventional Care Regimen

Drug: Conventional Care Regimen

Interventions

Azacitidine DRUG

75 mg/m\^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity

Also known as: Vidaza

Azacitidine

Conventional Care Regimen DRUG

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

Conventional Care Regimen

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Diagnosis of one of the following
• 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

You may not qualify if:

• Previous cytotoxic or biologic treatment for AML (except hydroxyurea)
• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (112)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

Western Hospital

Footscray, Victoria, 3011, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

St Vincent's Hospital

Fitzroy, 3065, Australia

Location

Klinikum Wels-Grieskirchen GmbH

Wels, Upper Austria, 4600, Austria

Location

Wilhelminenspital, I Medizinische Abt.

Vienna, Vienna, 1160, Austria

Location

Landeskliniken Salzburg Saint Johanns-Spital, III Medizinische Abteilung

Salzburg, 5020, Austria

Location

Grand Hôpital de Charleroi

Charleroi, Hainaut, 6000, Belgium

Location

Cliniques Universitaires UCL de Mont-Godinne

Yvoir, Namur, 5530, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Oost-vlaanderen, 9000, Belgium

Location

Algemeen Ziekenhuis Sint-Jan

Bruges, West-vlaanderen, 8000, Belgium

Location

Centre Hospitalier de Jolimont-Lobbes

La Louvière, 7100, Belgium

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Ottawa Hospital General Campus

Ottawa, Ontario, K1H8L6, Canada

Location

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Centre Hospitalier de l'Université de Montréal pavilion Notre Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Hopital du Sacre Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Tom Baker Cancer Centre

Calgary, T2N 2T9, Canada

Location

Princess Margaret Hospital

Ontario, M5G 2M9, Canada

Location

The Third Hospital of Peking University

Beijing, 100083, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Peoples Hospital of Jiangsu Province

Jiangsu, 210029, China

Location

Shanghai Ruijin Hospital

Shanghai, 200025, China

Location

Shanghai Changhai Hospital,the Second Military Medical University

Shanghai, 200433, China

Location

West China Hospital,Sichuan University

Sichuan, 610041, China

Location

Tianjin Blood Disease Hospital

Tianjin, 3000200, China

Location

Fakultni nemocnice Brno

Brno, Jihormoravsky Kraj, 625 00, Czechia

Location

Fakultni nemocnice Olomouc, hemato-onkologicka klinika

Olomouc, Olomoucký kraj, 775 20, Czechia

Location

Vseobecna Fakultni Nemocnice v Praze

Prague, Prague, 128 08, Czechia

Location

Ustav hematologie a krevni transfuze

Prague, Prague, 128 20, Czechia

Location

Centre Hospitalier Régional Universitaire, Hôpital de Hautepierre

Strasbourg, Alsace, 67091, France

Location

Centre Hopitalier Universitaire Dupuytren

Limoges, Limousin Lorraine, 87042, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, Midi-pyrénées, 31059, France

Location

Centre Hospitalier Universitaire de Nice

Nice, Nice, 06202, France

Location

CHRU d'Angers

Angers, Pays de la Loire Region, 49933, France

Location

Centre Hospitalier Universitaire Nantes, Hotel Dieu

Nantes, Pays de la Loire Region, 44093, France

Location

Centre Hospitalier Universitaire d'Amiens, Groupe Hospitalier Sud

Amiens, Picardie, 80054, France

Location

Hôpital de la Conception

Marseille, Provence-Alpes-Côte d'Azur Region, 13385, France

Location

Centre Hospitalier de la Cote Basque

Aquitaine, 64109, France

Location

Centre Hospitalier Universitaire de Lyon-Hôpital Edouard Herriot

Lyon, 69437, France

Location

Hospital Avicenne, Service d'hematologie Clinique

Bobigny, Île-de-France Region, 93009, France

Location

Hopital Percy Clamart

Clamart, Île-de-France Region, 92141, France

Location

Hôpital Saint Louis

Paris, Île-de-France Region, 75475, France

Location

Universitatsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

University of Rostock, Div. of Haematology and Oncology

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Universitatsklinikum Essen, Zentrum fur Tumorforschung und Tumortherapie

Essen, Nordrhein-Westfallen, 45122, Germany

Location

Heinrich-Heine-Universität Düsseldorf

Düesseldorf, North Rhine-Westphalia, 40211, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

Location

Soroka Medical Center

Beersheba, Beersheva, 84101, Israel

Location

Assaf Harofeh Medical Centre

Beer Yaakov, 70300, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Chaim Sheba Medical Center - Tel Hashomer, Heart Institute

Tel Litwinsky, 52621, Israel

Location

IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture

Rionero in Vulture, Potenza, 85028, Italy

Location

Azienda Sanitaria Ospedaliera "San Luigi Gonzaga"

Orbassano, Turin, 10043, Italy

Location

Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

Alessandria, 15121, Italy

Location

Azienda Ospedaliera Universitaria - Ospedali Riuniti di Ancona

Ancona, 60126, Italy

Location

Azienda Ospedaliera Policlinico di Bari

Bari, 70124, Italy

Location

Azienda Ospedaliera Sant'Orsola Malpighi

Bologna, 40138, Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

Location

Azienda Ospedaliera Bianchi-Melacrino-Morelli

Reggio Calabria, 89100, Italy

Location

Azienda Policlinico Umberto I di Roma

Roma, 00161, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine

Udine, 33100, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Universitair Medisch Centrum Groningen

Groningen, 9700 RB, Netherlands

Location

Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

Location

Dolnoslaskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku

Wroclaw, Lower Silesian Voivodeship, 53-439, Poland

Location

Instytut Hematologii i Transfuzjologii

Warsaw, Masovian Voivodeship, 02-776, Poland

Location

Samodzielny Publiczny SK im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach

Katowice, Silesian Voivodeship, 40-032, Poland

Location

Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

Lódz, Łódź Voivodeship, 93-510, Poland

Location

City Clinical Hospital n.a. S. P. Botkin

Moscow, 125284, Russia

Location

State Healthcare Institution "Nizhny Novgorod N.A. Semashko Regional Clinical Hospital"

Nizhny Novgorod, 603126, Russia

Location

Saint Petersburg State Academician I.P. Pavlov Medical University

Saint Petersburg, 197089, Russia

Location

Saratov State Medical University

Saratov, 410 028, Russia

Location

Central City Hospital # 7

Yekaterinburg, 620137, Russia

Location

Samsung Medical Center

Gangnam-gu, Seoul, 135-710, South Korea

Location

Seoul National University Hospital

Jongno-gu, Seoul, 110-774, South Korea

Location

Yonsei University Health System

Seodaemun-gu, Seoul, 120-752, South Korea

Location

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Seoul Saint Mary's Hospital Seocho-gu

Seoul, 137-701, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Korea University Hospital at Guro

Seoul, 152-703, South Korea

Location

Hospital Son Dureta

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Hospital Son Llàtzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Hospital Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28009, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Universitario La Fe

Valencia, 46009, Spain

Location

Chang Gung Memorial Hospital, Kaohsiung

Niao-Sung Hsiang, Kaohsiung, 83301, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital Pei-Tou District

Taipei, 11217, Taiwan

Location

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Barts and the London NHS Trust

London, EC1A 7BE, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

Churchill Hospital

Oxford, OX3 9DS, United Kingdom

Location

New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29241450 DERIVED

• 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.

  PMID: 25987659 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Anne McClain, Senior Manager Clinical Trial Disclosure
• Organization: Celgene

ClinicalTrialDisclosure@celgene.com

888-260-1599

Study Officials

• C L Beach, PharmD

  Celgene Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 24, 2010
• Study Start: June 1, 2010
• Primary Completion: January 22, 2014
• Study Completion: July 25, 2016
• Last Updated: August 29, 2017
• Results First Posted: February 26, 2015

Record last verified: 2017-08

Locations

CN (7); IT (12); IL (7); RU (5); TW (3); AU (3); US (2); KR (7); CZ (4); PL (5); BE (5); DE (7); NL (1); GB (7); ES (8); CA (10); FR (13)