Acute Myeloid Leukemia Clinical Trial
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
Verified date | August 2017 |
Source | Celgene |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.
Status | Completed |
Enrollment | 488 |
Est. completion date | July 25, 2016 |
Est. primary completion date | January 22, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Peter MacCallum Cancer Centre | East Melbourne | Victoria |
Australia | St Vincent's Hospital | Fitzroy | |
Australia | Western Hospital | Footscray | Victoria |
Australia | Royal Melbourne Hospital | Melbourne | Victoria |
Australia | Prince of Wales Hospital | Randwick | New South Wales |
Austria | Landeskliniken Salzburg Saint Johanns-Spital, III Medizinische Abteilung | Salzburg | |
Austria | Klinikum Wels-Grieskirchen GmbH | Wels | Upper Austria |
Austria | Wilhelminenspital, I Medizinische Abt. | Wien | Vienna |
Belgium | Algemeen Ziekenhuis Sint-Jan | Brugge | West-vlaanderen |
Belgium | Grand Hôpital de Charleroi | Charleroi | Hainaut |
Belgium | Universitair Ziekenhuis Gent | Ghent | Oost-vlaanderen |
Belgium | Centre Hospitalier de Jolimont-Lobbes | La Louvière | |
Belgium | Cliniques Universitaires UCL de Mont-Godinne | Yvoir | Namur |
Canada | Tom Baker Cancer Centre | Calgary | |
Canada | University of Alberta Hospital | Edmonton | Alberta |
Canada | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia |
Canada | Centre Hospitalier de l'Université de Montréal pavilion Notre Dame | Montreal | Quebec |
Canada | Hopital du Sacre Coeur de Montréal | Montreal | Quebec |
Canada | Hopital Maisonneuve-Rosemont | Montreal | Quebec |
Canada | Princess Margaret Hospital | Ontario | |
Canada | Ottawa Hospital General Campus | Ottawa | Ontario |
Canada | Sunnybrook Odette Cancer Centre | Toronto | Ontario |
Canada | Cancer Care Manitoba | Winnipeg | Manitoba |
China | Peking Union Medical College Hospital | Beijing | |
China | The Third Hospital of Peking University | Beijing | |
China | Peoples Hospital of Jiangsu Province | Jiangsu | |
China | Shanghai Changhai Hospital,the Second Military Medical University | Shanghai | |
China | Shanghai Ruijin Hospital | Shanghai | |
China | West China Hospital,Sichuan University | Sichuan | |
China | Tianjin Blood Disease Hospital | Tianjin | |
Czechia | Fakultni nemocnice Brno | Brno | Jihormoravsky Kraj |
Czechia | Fakultni nemocnice Olomouc, hemato-onkologicka klinika | Olomouc | Olomoucký Kraj |
Czechia | Ustav hematologie a krevni transfuze | Praha 2 | Praha |
Czechia | Vseobecna Fakultni Nemocnice v Praze | Praha 2 | Praha |
France | Centre Hospitalier Universitaire d'Amiens, Groupe Hospitalier Sud | Amiens Cedex 1 | Picardie |
France | CHRU d'Angers | Angers cedex 09 | Pays de La Loire |
France | Centre Hospitalier de la Cote Basque | Aquitaine | |
France | Hospital Avicenne, Service d'hematologie Clinique | Bobigny | ILE-DE-France |
France | Hopital Percy Clamart | Clamart Cedex | Ile-de-france |
France | Centre Hopitalier Universitaire Dupuytren | Limoges | Limousin Lorraine |
France | Centre Hospitalier Universitaire de Lyon-Hôpital Edouard Herriot | Lyon Cedex 03 | |
France | Hôpital de la Conception | Marseille | Provence Alpes Cote D'azur |
France | Centre Hospitalier Universitaire Nantes, Hotel Dieu | Nantes Cedex 1 | Pays de La Loire |
France | Centre Hospitalier Universitaire de Nice | Nice Cedex 3 | Nice |
France | Hôpital Saint Louis | Paris Cedex 10 | Ile-de-france |
France | Centre Hospitalier Régional Universitaire, Hôpital de Hautepierre | Strasbourg | Alsace |
France | Centre Hospitalier Universitaire de Toulouse | Toulouse Cedex 09 | Midi-pyrénées |
Germany | Heinrich-Heine-Universität Düsseldorf | Düesseldorf | Nordrhein-westfalen |
Germany | Universitatsklinikum Essen, Zentrum fur Tumorforschung und Tumortherapie | Essen | Nordrhein-Westfallen |
Germany | Universitatsklinikum Heidelberg | Heidelberg | Baden-wuerttemberg |
Germany | Universitätsklinikum Jena | Jena | Thueringen |
Germany | Universitätsklinikum Leipzig | Leipzig | Sachsen |
Germany | University of Rostock, Div. of Haematology and Oncology | Rostock | Mecklenburg-vorpommern |
Germany | Universitätsklinikum Ulm | Ulm | Baden-wuerttemberg |
Israel | Soroka Medical Center | Beer Sheva | Beersheva |
Israel | Assaf Harofeh Medical Centre | Beer Yaakov | |
Israel | Hadassah Medical Center | Jerusalem | |
Israel | Shaare Zedek Medical Center | Jerusalem | |
Israel | Rabin Medical Center | Petach Tikva | |
Israel | Sourasky Medical Center | Tel Aviv | |
Israel | Chaim Sheba Medical Center - Tel Hashomer, Heart Institute | Tel Hashomer | |
Italy | Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria | Alessandria | |
Italy | Azienda Ospedaliera Universitaria - Ospedali Riuniti di Ancona | Ancona | |
Italy | Azienda Ospedaliera Policlinico di Bari | Bari | |
Italy | Azienda Ospedaliera Sant'Orsola Malpighi | Bologna | |
Italy | Azienda Ospedaliero-Universitaria Careggi | Firenze | |
Italy | Azienda Sanitaria Ospedaliera "San Luigi Gonzaga" | Orbassano | Turin |
Italy | Azienda Ospedaliera Bianchi-Melacrino-Morelli | Reggio Calabria | |
Italy | IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture | Rionero in Vulture | Potenza |
Italy | Azienda Policlinico Umberto I di Roma | Roma | |
Italy | Policlinico Universitario Agostino Gemelli | Roma | |
Italy | Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine | Udine | |
Italy | Ospedale di Circolo e Fondazione Macchi | Varese | |
Korea, Republic of | Kyungpook National University Hospital | Daegu | |
Korea, Republic of | Samsung Medical Center | Gangnam-gu | Seoul |
Korea, Republic of | Seoul National University Hospital | Jongno-gu | Seoul |
Korea, Republic of | Yonsei University Health System | Seodaemun-gu | Seoul |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Korea University Hospital at Guro | Seoul | |
Korea, Republic of | Seoul Saint Mary's Hospital Seocho-gu | Seoul | |
Netherlands | Universitair Medisch Centrum Groningen | Groningen | |
Poland | Samodzielny Publiczny SK im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach | Katowice | Slaskie |
Poland | Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika | Lódz | Lodzkie |
Poland | Instytut Hematologii i Transfuzjologii | Warszawa | Mazowieckie |
Poland | Dolnoslaskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku | Wroclaw | Dolnoslaskie |
Poland | Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku | Wroclaw | Dolnoslaskie |
Russian Federation | Central City Hospital # 7 | Ekaterinburg | |
Russian Federation | City Clinical Hospital n.a. S. P. Botkin | Moscow | |
Russian Federation | State Healthcare Institution "Nizhny Novgorod N.A. Semashko Regional Clinical Hospital" | Nizhniy Novgorod | |
Russian Federation | Saint Petersburg State Academician I.P. Pavlov Medical University | Saint Petersburg | |
Russian Federation | Saratov State Medical University | Saratov | |
Spain | Hospital Clinic i Provincial de Barcelona | Barcelona | |
Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
Spain | Hospital Central de Asturias | Oviedo | Asturias |
Spain | Hospital Son Dureta | Palma de Mallorca | Baleares |
Spain | Hospital Son Llàtzer | Palma de Mallorca | Baleares |
Spain | Hospital Universitario de Salamanca | Salamanca | |
Spain | Hospital Universitario Virgen del Rocío | Sevilla | |
Spain | Hospital Universitario La Fe | Valencia | |
Taiwan | Chang Gung Memorial Hospital, Kaohsiung | Niao-Sung Hsiang | Kaohsiung |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Taipei Veterans General Hospital Pei-Tou District | Taipei | |
United Kingdom | Royal Bournemouth Hospital | Bournemouth | |
United Kingdom | Barts and the London NHS Trust | London | |
United Kingdom | King's College Hospital | London | |
United Kingdom | Manchester Royal Infirmary | Manchester | |
United Kingdom | Churchill Hospital | Oxford | |
United Kingdom | Royal Marsden Hospital | Sutton | Surrey |
United Kingdom | New Cross Hospital | Wolverhampton | |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Celgene |
United States, Australia, Austria, Belgium, Canada, China, Czechia, France, Germany, Israel, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kaplan-Meier Estimates for Overall Survival | Overall Survival was defined as the time from randomization to death from any cause. Overall survival was calculated by the formula: date of death - date of randomization + 1. Participants surviving at the end of the follow-up period or who withdrew consent to follow-up were censored at the date of last contact. Participants who were lost to follow-up were censored at the date last known alive. | Day 1 (randomization) to 40 months | |
Secondary | 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. | From Day 1 (randomization) to 40 months | |
Secondary | 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. | 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 | |
Secondary | 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. | 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 | |
Secondary | 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. | Day 1 (randomization) to 40 months | |
Secondary | 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. | Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse. | |
Secondary | 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 | Day 1 (randomization) to 40 months | |
Secondary | 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 | Day 1 (randomization) up to last visit completed; final data cut off of 28 Feb 2017 | |
Secondary | 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). | Baseline to Cycle 3; at approximately 3 months | |
Secondary | 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). | Baseline to Cycle 5, at approximately 5 months | |
Secondary | 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). | Baseline to Cycle 7, at approximately 7 months | |
Secondary | 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). | Baseline to Cycle 9, at approximately 9 months | |
Secondary | 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). | Baseline to End of Study; at approximately 11-12 months | |
Secondary | 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). | Baseline to Cycle 3, at approximately 3 months | |
Secondary | 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). | Baseline to Cycle 5, at approximately 5 months | |
Secondary | 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). | Baseline to Cycle 7, at approximately 7 months | |
Secondary | 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). | Baseline to Cycle 9, at approximately 9 months | |
Secondary | 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). | Baseline to end of study, at approximately 11-12 months | |
Secondary | 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. | Baseline to Cycle 3, at approximately 3 months | |
Secondary | 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. | Baseline to Cycle 5, at approximately 5 months | |
Secondary | 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. | Baseline to Cycle 7, at approximately 7 months | |
Secondary | 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. | Baseline to Cycle 9, at approximately 9 months | |
Secondary | 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. | Baseline to end of study, at approximately 11-12 months | |
Secondary | 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. | Baseline to Cycle 3, at approximately 3 months | |
Secondary | 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. | Baseline to Cycle 5, at approximately 5 months | |
Secondary | 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. | Baseline to Cycle 7, at approximately 7 months | |
Secondary | 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. | Baseline to Cycle 9, at approximately 9 months | |
Secondary | 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. | Baseline to end of study, at approximately 11-12 months | |
Secondary | 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. | Day 1 (randomization) to 40 months | |
Secondary | 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. | Day 1 (randomization) to 40 months | |
Secondary | 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. | Day 1 (randomization) to 40 months | |
Secondary | 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. | Day 1 (randomization) to 40 months | |
Secondary | 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 | 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 |
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