Acute Myeloid LeukemiaPhase 3NCT01074047
Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)
A Phase 3 study testing Azacitidine and Conventional Care Regimen in people with Acute Myeloid Leukemia, run by Celgene at 112 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Azacitidine and Conventional Care Regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 112 sitesin 18 countries
- Study dates
- 1 Jun 2010to 25 Jul 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
112 sites in 18 countries.
112 sites in 18 countries
France13 sites
Centre Hospitalier Universitaire d'Amiens, Groupe Hospitalier Sud
Amiens, Picardie, 80054
CHRU d'Angers
Angers, Pays de la Loire Region, 49933
Centre Hospitalier de la Cote Basque
Aquitaine, 64109
Hospital Avicenne, Service d'hematologie Clinique
Bobigny, Île-de-France Region, 93009
Hopital Percy Clamart
Clamart, Île-de-France Region, 92141
Centre Hopitalier Universitaire Dupuytren
Limoges, Limousin Lorraine, 87042
Centre Hospitalier Universitaire de Lyon-Hôpital Edouard Herriot
Lyon, 69437
Hôpital de la Conception
Marseille, Provence-Alpes-Côte d'Azur Region, 13385
Centre Hospitalier Universitaire Nantes, Hotel Dieu
Nantes, Pays de la Loire Region, 44093
Centre Hospitalier Universitaire de Nice
Nice, Nice, 06202
Hôpital Saint Louis
Paris, Île-de-France Region, 75475
Centre Hospitalier Régional Universitaire, Hôpital de Hautepierre
Strasbourg, Alsace, 67091
Centre Hospitalier Universitaire de Toulouse
Toulouse, Midi-pyrénées, 31059
Italy12 sites
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
Alessandria, 15121
Azienda Ospedaliera Universitaria - Ospedali Riuniti di Ancona
Ancona, 60126
Azienda Ospedaliera Policlinico di Bari
Bari, 70124
Azienda Ospedaliera Sant'Orsola Malpighi
Bologna, 40138
Azienda Ospedaliero-Universitaria Careggi
Florence, 50134
Azienda Sanitaria Ospedaliera "San Luigi Gonzaga"
Orbassano, Turin, 10043
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Reggio Calabria, 89100
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
Rionero in Vulture, Potenza, 85028
Azienda Policlinico Umberto I di Roma
Roma, 00161
Policlinico Universitario Agostino Gemelli
Roma, 00168
Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine
Udine, 33100
Ospedale di Circolo e Fondazione Macchi
Varese, 21100
Canada10 sites
Tom Baker Cancer Centre
Calgary, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Centre Hospitalier de l'Université de Montréal pavilion Notre Dame
Montreal, Quebec, H2L 4M1
Hopital du Sacre Coeur de Montréal
Montreal, Quebec, H4J 1C5
Princess Margaret Hospital
Ontario, M5G 2M9
Ottawa Hospital General Campus
Ottawa, Ontario, K1H8L6
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9
Spain8 sites
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
Hospital General Universitario Gregorio Marañon
Madrid, 28009
Hospital Central de Asturias
Oviedo, Principality of Asturias, 33006
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, 07014
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, 07198
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital Universitario La Fe
Valencia, 46009
China7 sites
The Third Hospital of Peking University
Beijing, 100083
Peking Union Medical College Hospital
Beijing, 100730
Peoples Hospital of Jiangsu Province
Jiangsu, 210029
Shanghai Ruijin Hospital
Shanghai, 200025
Shanghai Changhai Hospital,the Second Military Medical University
Shanghai, 200433
West China Hospital,Sichuan University
Sichuan, 610041
Tianjin Blood Disease Hospital
Tianjin, 3000200
Germany7 sites
Heinrich-Heine-Universität Düsseldorf
Düesseldorf, North Rhine-Westphalia, 40211
Universitatsklinikum Essen, Zentrum fur Tumorforschung und Tumortherapie
Essen, Nordrhein-Westfallen, 45122
Universitatsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Universitätsklinikum Jena
Jena, Thuringia, 07747
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
University of Rostock, Div. of Haematology and Oncology
Rostock, Mecklenburg-Vorpommern, 18057
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081
Israel7 sites
Assaf Harofeh Medical Centre
Beer Yaakov, 70300
Soroka Medical Center
Beersheba, Beersheva, 84101
Shaare Zedek Medical Center
Jerusalem, 91031
Hadassah Medical Center
Jerusalem, 91120
Rabin Medical Center
Petah Tikva, 49100
Sourasky Medical Center
Tel Aviv, 64239
Chaim Sheba Medical Center - Tel Hashomer, Heart Institute
Tel HaShomer, 52621
South Korea7 sites
Kyungpook National University Hospital
Daegu, 700-721
Samsung Medical Center
Gangnam-gu, Seoul, 135-710
Seoul National University Hospital
Jongno-gu, Seoul, 110-774
Yonsei University Health System
Seodaemun-gu, Seoul, 120-752
Seoul Saint Mary's Hospital Seocho-gu
Seoul, 137-701
Asan Medical Center
Seoul, 138-736
Korea University Hospital at Guro
Seoul, 152-703
United Kingdom7 sites
Royal Bournemouth Hospital
Bournemouth, BH7 7DW
Barts and the London NHS Trust
London, EC1A 7BE
King's College Hospital
London, SE5 9RS
Manchester Royal Infirmary
Manchester, M13 9WL
Churchill Hospital
Oxford, OX3 9DS
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
New Cross Hospital
Wolverhampton, WV10 0QP
Australia6 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002
St Vincent's Hospital
Fitzroy, 3065
Western Hospital
Footscray, Victoria, 3011
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Prince of Wales Hospital
Randwick, New South Wales, 2031
Belgium5 sites
Algemeen Ziekenhuis Sint-Jan
Bruges, West-vlaanderen, 8000
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6000
Universitair Ziekenhuis Gent
Ghent, Oost-vlaanderen, 9000
Centre Hospitalier de Jolimont-Lobbes
La Louvière, 7100
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Namur, 5530
Poland5 sites
Samodzielny Publiczny SK im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, Silesian Voivodeship, 40-032
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
Lódz, Łódź Voivodeship, 93-510
Instytut Hematologii i Transfuzjologii
Warsaw, Masovian Voivodeship, 02-776
Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
Wroclaw, Lower Silesian Voivodeship, 50-367
Dolnoslaskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
Wroclaw, Lower Silesian Voivodeship, 53-439
Russia5 sites
City Clinical Hospital n.a. S. P. Botkin
Moscow, 125284
State Healthcare Institution "Nizhny Novgorod N.A. Semashko Regional Clinical Hospital"
Nizhny Novgorod, 603126
Saint Petersburg State Academician I.P. Pavlov Medical University
Saint Petersburg, 197089
Saratov State Medical University
Saratov, 410 028
Central City Hospital # 7
Yekaterinburg, 620137
Czechia4 sites
Fakultni nemocnice Brno
Brno, Jihormoravsky Kraj, 625 00
Fakultni nemocnice Olomouc, hemato-onkologicka klinika
Olomouc, Olomouc Region, 775 20
Vseobecna Fakultni Nemocnice v Praze
Prague, Prague, 128 08
Ustav hematologie a krevni transfuze
Prague, Prague, 128 20
Austria3 sites
Landeskliniken Salzburg Saint Johanns-Spital, III Medizinische Abteilung
Salzburg, 5020
Wilhelminenspital, I Medizinische Abt.
Vienna, State of Vienna, 1160
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, 4600
Taiwan3 sites
Chang Gung Memorial Hospital, Kaohsiung
Niao-Sung Hsiang, Kaohsiung, 83301
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital Pei-Tou District
Taipei, 11217
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02115
MD Anderson Cancer Center
Houston, Texas, 77030
Netherlands1 site
Universitair Medisch Centrum Groningen
Groningen, 9700 RB
About this study
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
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
- Being tested
- Azacitidine, Conventional Care Regimen
- Keywords
- Acute Myeloid Leukemia, Cytarabine, Vidaza, azacitidine, Intensive Chemotherapy, Low Dose Cytarabine, Celgene
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Also called Vidaza
75 mg/m^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
Conventional Care RegimenDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Azacitidine | Experimental | Azacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity Receives: Drug: Azacitidine |
| Conventional Care Regimen | Active comparator | Conventional Care Regimen Receives: Drug: Conventional Care Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (randomization) to 40 months
Secondary outcomes (32)
One-year Overall Survival Rate
Kaplan Meier methods were used to estimate the 1-year survival probabilities for time to death from any cause. Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.
Measured: From Day 1 (randomization) to 40 months
Event-free Survival (EFS)
Event-free survival was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after complete remission (CR) or complete remission with incomplete blood count recovery (CRi), death from any cause, or lost to follow-up, whichever occurs first. Participants who were still alive without any of these events were censored at the date of their last response assessment.
Measured: 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)
Relapse-free survival was defined 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 occurred first. Participants who were still alive and in continuous CR or CRi were censored at the date of their last response assessment.
Measured: 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)
A complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a BM aspirate with marrow spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods), an absolute neutrophil count (ANC) of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response. A CR with incomplete blood count recovery (CRi) is defined as <5% BM blasts with the ANC count < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Where the date of the hematology assessment used is the earliest on or following the date of the BM sample up to 8 days after the BM date.
Measured: Day 1 (randomization) to 40 months
Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates
The time from the date CR or CRi was first documented until the date of documented relapse from CR/CRi. Duration of remission was defined only for those participants who achieved a CR or CRi, as determined by the IRC. Participants who were lost to follow-up without documented relapse, or were alive at last follow-up without documented relapse were censored at the date of their last response assessment.
Measured: Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.
Number of Participants Who Achieved a Cytogenetic Complete Response (CRc-10) as Determined by the IRC.
The CRc is a normal karyotype defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) is when the following criteria are met: 1) CR criteria met and 2) an abnormal karyotype is present at baseline and 3) there is reversion to normal karyotype at the time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment
Measured: Day 1 (randomization) to 40 months
Number of Participants With Adverse Events (AEs)
AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen 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 participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
Measured: Day 1 (randomization) up to last visit completed; final data cut off of 28 Feb 2017
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Measured: Baseline to Cycle 3; at approximately 3 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Measured: Baseline to Cycle 5, at approximately 5 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Measured: Baseline to Cycle 7, at approximately 7 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Measured: Baseline to Cycle 9, at approximately 9 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Measured: Baseline to End of Study; at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Measured: Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Measured: Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Measured: Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Measured: Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Measured: Baseline to end of study, at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Measured: Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Measured: Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Measured: Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Measured: Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Measured: Baseline to end of study, at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Measured: Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Measured: Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Measured: Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Measured: Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Measured: Baseline to end of study, at approximately 11-12 months
Healthcare Resource Utilization (HRU): Number of Inpatient Hospitalizations
HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.
Measured: Day 1 (randomization) to 40 months
Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year
HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.
Measured: Day 1 (randomization) to 40 months
HRU: Number of Participants Receiving Transfusions
Count of study participants who had transfusions during the treatment phase. HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.
Measured: Day 1 (randomization) to 40 months
HRU: Rate of Transfusions Per Patient Year
HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of transfusions per patient year was calculated as the total number of transfusions divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.
Measured: Day 1 (randomization) to 40 months
Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs)
AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen 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 participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
Measured: From the date of informed consent for the Extension Phase through to the date of last dose of study drug + 28 days up to last visit completed 24 July 2016; maximum duration of exposure to Azacitidine was 871 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study start1 Jun 2010
- Primary completion22 Jan 2014
- Study completion25 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- C L Beach, PharmD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074047
- Sponsor's protocol ID
- AZA-AML-001
- Status last verified
- Aug 2017
- First submitted
- 16 Feb 2010
- Last updated
- 29 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 29241450Dombret 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.
PubMed 25987659
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01074047
- Acronym / sponsor ID
- AZA-AML-001
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Cytarabine, Vidaza, azacitidine, Intensive Chemotherapy, Low Dose Cytarabine, Celgene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2010 (actual)
- Primary completion
- 22 Jan 2014 (actual)
- Study completion
- 25 Jul 2016 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Posted 26 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azacitidine | Experimental | Drug: AzacitidineAzacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity |
| Conventional Care Regimen | Active comparator | Drug: Conventional Care RegimenConventional Care Regimen |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Diagnosis of one of the following
- Bone marrow blasts >30%
- Age ≥ 65 years
- Easter Cooperative Oncology Group (ECOG) 0-2
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzacitidineAlso: Vidaza75 mg/m^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity | Drug | Azacitidine |
| Conventional Care RegimenPhysician 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 | Drug | Conventional Care Regimen |
Primary outcome
Kaplan-Meier Estimates for Overall Survival
Time frame: Day 1 (randomization) to 40 months
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.
32 secondary outcomes
One-year Overall Survival Rate
Time frame: From Day 1 (randomization) to 40 months
Event-free Survival (EFS)
Time frame: 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)
Time frame: 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)
Time frame: Day 1 (randomization) to 40 months
Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates
Time frame: Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.
Number of Participants Who Achieved a Cytogenetic Complete Response (CRc-10) as Determined by the IRC.
Time frame: Day 1 (randomization) to 40 months
Number of Participants With Adverse Events (AEs)
Time frame: Day 1 (randomization) up to last visit completed; final data cut off of 28 Feb 2017
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
Time frame: Baseline to Cycle 3; at approximately 3 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
Time frame: Baseline to Cycle 5, at approximately 5 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
Time frame: Baseline to Cycle 7, at approximately 7 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
Time frame: Baseline to Cycle 9, at approximately 9 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
Time frame: Baseline to End of Study; at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
Time frame: Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
Time frame: Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
Time frame: Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
Time frame: Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
Time frame: Baseline to end of study, at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
Time frame: Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
Time frame: Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
Time frame: Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
Time frame: Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
Time frame: Baseline to end of study, at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
Time frame: Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
Time frame: Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
Time frame: Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
Time frame: Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
Time frame: Baseline to end of study, at approximately 11-12 months
Healthcare Resource Utilization (HRU): Number of Inpatient Hospitalizations
Time frame: Day 1 (randomization) to 40 months
Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year
Time frame: Day 1 (randomization) to 40 months
HRU: Number of Participants Receiving Transfusions
Time frame: Day 1 (randomization) to 40 months
HRU: Rate of Transfusions Per Patient Year
Time frame: Day 1 (randomization) to 40 months
Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs)
Time frame: From the date of informed consent for the Extension Phase through to the date of last dose of study drug + 28 days up to last visit completed 24 July 2016; maximum duration of exposure to Azacitidine was 871 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29241450Seymour 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.
- Derived from this study: PubMed 25987659Dombret 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C L Beach, PharmD study director
Celgene Corporation
112 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azacitidine and Conventional Care Regimen in people with Acute Myeloid Leukemia, run by Celgene at 112 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 112 sites in France, Italy, Canada, Spain, China and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kaplan-Meier Estimates for Overall Survival (time frame: Day 1 (randomization) to 40 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01074047, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.