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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01074047
First received: February 16, 2010
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: Azacitidine
Drug: Conventional Care Regimen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Open-Label, Study of Azacitidine (Vidaza®) Versus Conventional Care Regimens for the Treatment of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Overall Survival is defined as the median time from randomization to death from any cause


Secondary Outcome Measures:
  • One-year overall survival rate [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    One Year overall survival rate is defined as the percentage of participants alive at one year time point interval following randomization

  • Event free survival [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Event-free survival is defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after Complete Remision or incomplete blood count recovery (CRi), death from any cause, or lost to follow-up, whichever occurs first.

  • Overall remission rate [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Complete remission [CR] + morphologic complete remission with incomplete blood count recovery [CRi]) and duration of remission

  • Cytogenetic complete remission rate (CRc) [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Defined as morphologic complete remission with a reversion to a normal karyotype.

  • Number of participants with adverse events (AEs) [ Time Frame: Up to 31 months; Adverse Event (AEs) will be collected up to 28 days after last study drug dose or up to last study visit, whichever is longer ] [ Designated as safety issue: No ]
    An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values (as specified by the criteria below), regardless of etiology.

  • EORTC-QLQ-C-30 Quality of Life Instrument [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    The EORTC QLQ-C30 is a validated quality of life measure applicable to subjects with any cancer diagnosis. It is composed of 30 items that address general physical symptoms, physical functioning, fatigue and malaise, and social and emotional functioning. Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher scores on symptom scales indicating worse symptoms

  • Healthcare resource utilization [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Hospitalizations required for Treatment Emergent Adverse Events (TEAEs) including detail on number of events, total number of days hospitalized, the rate of events and days hospitalized per person-year of exposure

  • Relapse Free Survival [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    Relapse-free survival is defined only for subjects who achieve CR or CRi and is measured as the interval from the date of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up, whichever occurs first

  • Duration of Remission [ Time Frame: Up to 31 months ] [ Designated as safety issue: No ]
    The time from the date CR or CRi is first documented until the date of documented relapse from CR/CRi


Enrollment: 488
Study Start Date: June 2010
Estimated Study Completion Date: February 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azacitidine
Azacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
Drug: Azacitidine

A: Azacitidine

75 mg/m2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity

Other Name: Vidaza
Active Comparator: Conventional Care Regimen
Conventional Care Regimen
Drug: Conventional Care Regimen

B: Conventional Care Regimen

Physician pre-selects prior to randomization from one of the following:

  • Intensive chemotherapy (cytarabine 100-200 mg/m2 continuous IV infusion for 7 days + anthracycline IV x 3 days) + BSC; induction with up to 2 consolidation cycles
  • Low-dose cytarabine 20 mg subcutaneous (SC) BID daily for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity
  • Best Supportive Care only; until study end

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074047

  Hide Study Locations
Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Australia, New South Wales
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Western Hospital
Footscray, Victoria, Australia, 3011
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Australia
St Vincent's Hospital
Fitzroy, Australia, 3065
Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, Austria, 4600
Wilhelminenspital, I Medizinische Abt.
Wien, Vienna, Austria, 1160
Landeskliniken Salzburg Saint Johanns-Spital, III Medizinische Abteilung
Salzburg, Austria, 5020
Belgium
Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium, 6000
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Namur, Belgium, 5530
Universitair Ziekenhuis Gent
Ghent, Oost-vlaanderen, Belgium, 9000
Algemeen Ziekenhuis Sint-Jan
Brugge, West-vlaanderen, Belgium, 8000
Centre Hospitalier de Jolimont-Lobbes
La Louvière, Belgium, 7100
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Ottawa Hospital General Campus
Ottawa, Ontario, Canada, K1H8L6
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Hopital du Sacre Coeur de Montréal
Montreal, Quebec, Canada, H4J 1C5
Centre Hospitalier de l'Université de Montréal pavilion Notre Dame
Montreal, Quebec, Canada, H2L 4M1
Canada
Tom Baker Cancer Centre
Calgary, Canada, T2N 2T9
Princess Margaret Hospital
Ontario, Canada, M5G 2M9
China
Peking Union Medical College Hospital
Beijing, China, 100730
The Third Hospital of Peking University
Beijing, China, 100083
Peoples Hospital of Jiangsu Province
Jiangsu, China, 210029
Shanghai Ruijin Hospital
Shanghai, China, 200025
Shanghai Changhai Hospital,the Second Military Medical University
Shanghai, China, 200433
West China Hospital,Sichuan University
Sichuan, China, 610041
Tianjin Blood Disease Hospital
Tianjin, China, 3000200
Czech Republic
Fakultni nemocnice Brno
Brno, Jihormoravsky Kraj, Czech Republic, 625 00
Fakultni nemocnice Olomouc, hemato-onkologicka klinika
Olomouc, Olomoucký Kraj, Czech Republic, 775 20
Ustav hematologie a krevni transfuze
Praha 2, Praha, Czech Republic, 128 20
Vseobecna Fakultni Nemocnice v Praze
Praha 2, Praha, Czech Republic, 128 08
France
Centre Hospitalier Régional Universitaire, Hôpital de Hautepierre
Strasbourg, Alsace, France, 67091
Hospital Avicenne, Service d'hematologie Clinique
Bobigny, ILE-DE-France, France, 93009
Hopital Percy Clamart
Clamart Cedex, Ile-de-france, France, 92141
Hôpital Saint Louis
Paris Cedex 10, Ile-de-france, France, 75475
Centre Hopitalier Universitaire Dupuytren
Limoges, Limousin Lorraine, France, 87042
Centre Hospitalier Universitaire de Toulouse
Toulouse Cedex 09, Midi-pyrénées, France, 31059
Centre Hospitalier Universitaire de Nice
Nice Cedex 3, Nice, France, 06202
CHRU d'Angers
Angers cedex 09, Pays de La Loire, France, 49933
Centre Hospitalier Universitaire Nantes, Hotel Dieu
Nantes Cedex 1, Pays de La Loire, France, 44093
Centre Hospitalier Universitaire d'Amiens, Groupe Hospitalier Sud
Amiens Cedex 1, Picardie, France, 80054
Hôpital de la Conception
Marseille, Provence Alpes Cote D'azur, France, 13385
Centre Hospitalier de la Cote Basque
Aquitaine, France, 64109
Centre Hospitalier Universitaire de Lyon-Hôpital Edouard Herriot
Lyon Cedex 03, France, 69437
Germany
Universitatsklinikum Heidelberg
Heidelberg, Baden-wuerttemberg, Germany, 69120
Universitätsklinikum Ulm
Ulm, Baden-wuerttemberg, Germany, 89081
University of Rostock, Div. of Haematology and Oncology
Rostock, Mecklenburg-vorpommern, Germany, 18057
Heinrich-Heine-Universität Düsseldorf
Düesseldorf, Nordrhein-westfalen, Germany, 40211
Universitatsklinikum Essen, Zentrum fur Tumorforschung und Tumortherapie
Essen, Nordrhein-Westfallen, Germany, 45122
Universitätsklinikum Leipzig
Leipzig, Sachsen, Germany, 04103
Universitätsklinikum Jena
Jena, Thueringen, Germany, 07747
Israel
Soroka Medical Center
Beer Sheva, Beersheva, Israel, 84101
Assaf Harofeh Medical Centre
Beer Yaakov, Israel, 70300
Hadassah Medical Center
Jerusalem, Israel, 91120
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Rabin Medical Center
Petach Tikva, Israel, 49100
Sourasky Medical Center
Tel Aviv, Israel, 64239
Chaim Sheba Medical Center - Tel Hashomer, Heart Institute
Tel Hashomer, Israel, 52621
Italy
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
Rionero in Vulture, Potenza, Italy, 85028
Azienda Sanitaria Ospedaliera "San Luigi Gonzaga"
Orbassano, Turin, Italy, 10043
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
Alessandria, Italy, 15121
Azienda Ospedaliera Universitaria - Ospedali Riuniti di Ancona
Ancona, Italy, 60126
Azienda Ospedaliera Policlinico di Bari
Bari, Italy, 70124
Azienda Ospedaliera Sant'Orsola Malpighi
Bologna, Italy, 40138
Azienda Ospedaliero-Universitaria Careggi
Firenze, Italy, 50134
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Reggio Calabria, Italy, 89100
Azienda Policlinico Umberto I di Roma
Roma, Italy, 00161
Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine
Udine, Italy, 33100
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Korea, Republic of
Samsung Medical Center
Gangnam-gu, Seoul, Korea, Republic of, 135-710
Seoul National University Hospital
Jongno-gu, Seoul, Korea, Republic of, 110-774
Yonsei University Health System
Seodaemun-gu, Seoul, Korea, Republic of, 120-752
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Korea University Hospital at Guro
Seoul, Korea, Republic of, 152-703
Seoul Saint Mary's Hospital Seocho-gu
Seoul, Korea, Republic of, 137-701
Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9700 RB
Poland
Dolnoslaskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
Wroclaw, Dolnoslaskie, Poland, 53-439
Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
Wroclaw, Dolnoslaskie, Poland, 50-367
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
Lódz, Lodzkie, Poland, 93-510
Instytut Hematologii i Transfuzjologii
Warszawa, Mazowieckie, Poland, 02-776
Samodzielny Publiczny SK im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, Slaskie, Poland, 40-032
Russian Federation
Central City Hospital # 7
Ekaterinburg, Russian Federation, 620137
City Clinical Hospital n.a. S. P. Botkin
Moscow, Russian Federation, 125284
State Healthcare Institution "Nizhny Novgorod N.A. Semashko Regional Clinical Hospital"
Nizhniy Novgorod, Russian Federation, 603126
Saint Petersburg State Academician I.P. Pavlov Medical University
Saint Petersburg, Russian Federation, 197089
Saratov State Medical University
Saratov, Russian Federation, 410 028
Spain
Hospital Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Son Llàtzer
Palma de Mallorca, Baleares, Spain, 07198
Hospital Son Dureta
Palma de Mallorca, Baleares, Spain, 07014
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28009
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Universitario Virgen del Rocío
Sevilla, Spain, 41013
Hospital Universitario La Fe
Valencia, Spain, 46009
Taiwan
Chang Gung Memorial Hospital, Kaohsiung
Niao-Sung Hsiang, Kaohsiung, Taiwan, 83301
Taipei Veterans General Hospital Pei-Tou District
Taipei, Taiwan, 11217
National Taiwan University Hospital
Taipei, Taiwan, 10002
United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
King's College Hospital
London, United Kingdom, SE5 9RS
Barts and the London NHS Trust
London, United Kingdom, EC1A 7BE
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Churchill Hospital
Oxford, United Kingdom, OX3 9DS
New Cross Hospital
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: C L Beach, PharmD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01074047     History of Changes
Other Study ID Numbers: AZA-AML-001
Study First Received: February 16, 2010
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Canada: Ethics Review Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
United States: Institutional Review Board
Australia: Human Research Ethics Committee
Austria: Ethikkommission
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ethics Commission
Israel: Ministry of Health
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Ethics Committee
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Spanish Agency of Medicines
Taiwan: Department of Health
Taiwan: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
China: Food and Drug Administration

Keywords provided by Celgene Corporation:
Acute Myeloid Leukemia
Cytarabine
Vidaza
azacitidine
Intensive Chemotherapy
Low Dose Cytarabine
Celgene

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 29, 2014