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

25 augustus 2017 bijgewerkt door: Celgene

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

488

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Azacitidine
Azacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
Geneesmiddel: Azacitidine
75 mg/m^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
Andere namen:
  • Vidaza
Actieve vergelijker: Conventional Care Regimen
Geneesmiddel: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Kaplan-Meier Estimates for Overall Survival
Tijdsspanne: 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.
Day 1 (randomization) to 40 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
One-year Overall Survival Rate
Tijdsspanne: From Day 1 (randomization) to 40 months
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.
From Day 1 (randomization) to 40 months
Event-free Survival (EFS)
Tijdsspanne: 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
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.
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)
Tijdsspanne: 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
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.
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)
Tijdsspanne: Day 1 (randomization) to 40 months
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.
Day 1 (randomization) to 40 months
Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates
Tijdsspanne: Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.
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.
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.
Tijdsspanne: Day 1 (randomization) to 40 months
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
Day 1 (randomization) to 40 months
Number of Participants With Adverse Events (AEs)
Tijdsspanne: Day 1 (randomization) up to last visit completed; final data cut off of 28 Feb 2017
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
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
Tijdsspanne: Baseline to Cycle 3; at approximately 3 months
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).
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
Tijdsspanne: Baseline to Cycle 5, at approximately 5 months
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).
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
Tijdsspanne: Baseline to Cycle 7, at approximately 7 months
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).
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
Tijdsspanne: Baseline to Cycle 9, at approximately 9 months
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).
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
Tijdsspanne: Baseline to End of Study; at approximately 11-12 months
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).
Baseline to End of Study; at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
Tijdsspanne: Baseline to Cycle 3, at approximately 3 months
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).
Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
Tijdsspanne: Baseline to Cycle 5, at approximately 5 months
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).
Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
Tijdsspanne: Baseline to Cycle 7, at approximately 7 months
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).
Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
Tijdsspanne: Baseline to Cycle 9, at approximately 9 months
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).
Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
Tijdsspanne: Baseline to end of study, at approximately 11-12 months
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).
Baseline to end of study, at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
Tijdsspanne: Baseline to Cycle 3, at approximately 3 months
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.
Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
Tijdsspanne: Baseline to Cycle 5, at approximately 5 months
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.
Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
Tijdsspanne: Baseline to Cycle 7, at approximately 7 months
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.
Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
Tijdsspanne: Baseline to Cycle 9, at approximately 9 months
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.
Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
Tijdsspanne: Baseline to end of study, at approximately 11-12 months
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.
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
Tijdsspanne: Baseline to Cycle 3, at approximately 3 months
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.
Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
Tijdsspanne: Baseline to Cycle 5, at approximately 5 months
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.
Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
Tijdsspanne: Baseline to Cycle 7, at approximately 7 months
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.
Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
Tijdsspanne: Baseline to Cycle 9, at approximately 9 months
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.
Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
Tijdsspanne: Baseline to end of study, at approximately 11-12 months
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.
Baseline to end of study, at approximately 11-12 months
Healthcare Resource Utilization (HRU): Number of Inpatient Hospitalizations
Tijdsspanne: Day 1 (randomization) to 40 months
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.
Day 1 (randomization) to 40 months
Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year
Tijdsspanne: Day 1 (randomization) to 40 months
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.
Day 1 (randomization) to 40 months
HRU: Number of Participants Receiving Transfusions
Tijdsspanne: Day 1 (randomization) to 40 months
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.
Day 1 (randomization) to 40 months
HRU: Rate of Transfusions Per Patient Year
Tijdsspanne: Day 1 (randomization) to 40 months
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.
Day 1 (randomization) to 40 months
Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs)
Tijdsspanne: 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
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
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

Medewerkers en onderzoekers

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Sponsor

Celgene

Onderzoekers

  • Studie directeur: C L Beach, PharmD, Celgene Corporation

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

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Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2010

Primaire voltooiing (Werkelijk)

22 januari 2014

Studie voltooiing (Werkelijk)

25 juli 2016

Studieregistratiedata

Eerst ingediend

16 februari 2010

Eerst ingediend dat voldeed aan de QC-criteria

22 februari 2010

Eerst geplaatst (Schatting)

24 februari 2010

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 augustus 2017

Laatste update ingediend die voldeed aan QC-criteria

25 augustus 2017

Laatst geverifieerd

1 augustus 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AZA-AML-001

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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