Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Subject's choice of treatment with physician's advice. Subjects preselected their preference of supportive care (including IV fluids, nutrition, and antibiotics) or cytarabine. (These represent one intervention.) |
|
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytarabine or Supportive Care | Drug | Patient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one intervention.) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML. | The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first. | The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp) | Morphologic CR plus CRp rate where Morphologic leukemia-free state defined as less that (<) 5 percent (%) blasts in an aspirate sample with marrow spicules and a count of greater than or equal to (>=) 200 nucleated cells (there should have been no blasts with Auer rods or persistence of extramedullary disease) plus absolute neutrophil count (ANC) greater than (>)1,000 per microliter (/mcL), platelet count of >=100,000/mcL, and the participant must have been independent of transfusions for at least 1 week before each assessment. There was no duration requirement for confirmation of this designation and Morphologic CR without the requirement of platelet count >=100,000/mcL. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eisai Medical Services | Eisai Global Clinical Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24498872 | Derived | Mayer J, Arthur C, Delaunay J, Mazur G, Thomas XG, Wierzbowska A, Ravandi F, Berrak E, Jones M, Li Y, Kantarjian HM. Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics. BMC Cancer. 2014 Feb 6;14:69. doi: 10.1186/1471-2407-14-69. |
Not provided
Not provided
Prior to randomization, subjects indicated their preference for treatment, with physician's advice, or either cytarabine or supportive care in the event they were randomized to Arm A.
This study was recruited at 65 centers in 12 countries during the period of 2006 to 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cytarabine or Supportive Care | Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.) |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Dacogen (decitabine) only | Drug | 20mg/m^2, 1 hour intravenous (IV) for 5 consecutive days of each 28 day cycle. Cycles continue until disease progression or unacceptable toxicity develops. |
|
|
| Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months) |
| Fort Myers |
| Florida |
| 33901 |
| United States |
| Gainesville | Florida | 32610 | United States |
| Hollywood | Florida | United States |
| Lakeland | Florida | 33805 | United States |
| Miami | Florida | United States |
| Orange Park | Florida | 32073 | United States |
| Chicago | Illinois | 60612 | United States |
| Highland Park | Illinois | United States |
| Terre Haute | Indiana | 47804 | United States |
| Sioux City | Iowa | 51101 | United States |
| Wichita | Kansas | 67214 | United States |
| Baton Rouge | Louisiana | United States |
| Shreveport | Louisiana | United States |
| Boston | Massachusetts | United States |
| Springfield | Massachusetts | 01107 | United States |
| Grosse Pointe Woods | Michigan | 48236 | United States |
| Kalamazoo | Michigan | 49048 | United States |
| Neptune City | New Jersey | United States |
| New York | New York | United States |
| Valhalla | New York | 10595 | United States |
| Durham | North Carolina | 27710 | United States |
| Canton | Ohio | 44710 | United States |
| Cincinnati | Ohio | 45267 | United States |
| Pittsburgh | Pennsylvania | 15232 | United States |
| Charleston | South Carolina | 29406 | United States |
| Greenville | South Carolina | United States |
| Sioux Falls | South Dakota | 57105 | United States |
| Knoxville | Tennessee | 37920 | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | 78705 | United States |
| Galveston | Texas | 77555 | United States |
| Houston | Texas | 77030 | United States |
| Temple | Texas | United States |
| Eau Claire | Wisconsin | United States |
| Glendale | Wisconsin | 53212 | United States |
| Milwaukee | Wisconsin | United States |
| Darlinghurst | New South Wales | Australia |
| St Leonards | New South Wales | 2065 | Australia |
| South Brisbane | Queensland | 4101 | Australia |
| Adelaide | South Australia | Australia |
| East Melbourne | Victoria | 3002 | Australia |
| Parkville | Victoria | 3052 | Australia |
| Perth | Western Australia | 6000 | Australia |
| St. John's | Newfoundland and Labrador | AiB 3V6 | Canada |
| Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Rijeka | Croatia |
| Zagreb | Croatia |
| Zalaegerszeg | Croatia |
| Brno | 62500 | Czechia |
| České Budějovice | Czechia |
| Pilsen | Czechia |
| Prague | 128 08 | Czechia |
| Bobigny | 93009 | France |
| Créteil | France |
| Lille | 59037 | France |
| Limoges | France |
| Lyon | 69437 | France |
| Nantes | 44000 | France |
| Pessac | France |
| Budapest | Hungary |
| Győr | 9024 | Hungary |
| Gyula | 5700 | Hungary |
| Szeged | Hungary |
| Szombathely | Hungary |
| Mexico City | Mexico |
| Gdansk | Poland |
| Krakow | Poland |
| Lodz | 93-510 | Poland |
| Lublin | 20-081 | Poland |
| Poznan | Poland |
| Warsaw | Poland |
| Wroclaw | 50-367 | Poland |
| Bucharest | Romania |
| Cluj-Napoca | 400124 | Romania |
| Târgu Mureş | 540042 | Romania |
| Arkhangelsk | Russia |
| Astrakhan | Russia |
| Barnaul | Russia |
| Izhevsk | Russia |
| Kirov | Russia |
| Kransnodar | Russia |
| Moscow | Russia |
| Novosibirsk | Russia |
| Petrozavodsk | Russia |
| Ryazan | Russia |
| Saint Petersburg | Russia |
| Samara | Russia |
| Saratov | Russia |
| Tyumen | Russia |
| Volgograd | Russia |
| Belgrade | 11000 | Serbia |
| Niš | Serbia |
| Novi Sad | 21000 | Serbia |
| Badalona-Barcelona | 08916 | Spain |
| Barcelona | 08035 | Spain |
| Girona | Spain |
| Madrid | 28006 | Spain |
| Palma de Mallorca | 07014 | Spain |
| Pamplona | 31008 | Spain |
| Salamanca | Spain |
| Valencia | Spain |
| Changhua | Taiwan |
| Kaohsiung City | Taiwan |
| Tainan | 70403 | Taiwan |
| Taipei | 10449 | Taiwan |
| Sutton | United Kingdom |
| Dacogen (Decitabine) Only |
20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cytarabine or Supportive Care | Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.) |
| BG001 | Dacogen (Decitabine) Only | 20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML. | The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first. | The primary population for all efficacy analyses was the Intent-to-treat (ITT) population defined as all subjects randomly allocated to a treatment arm. | Posted | Median | Full Range | months | The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp) | Morphologic CR plus CRp rate where Morphologic leukemia-free state defined as less that (<) 5 percent (%) blasts in an aspirate sample with marrow spicules and a count of greater than or equal to (>=) 200 nucleated cells (there should have been no blasts with Auer rods or persistence of extramedullary disease) plus absolute neutrophil count (ANC) greater than (>)1,000 per microliter (/mcL), platelet count of >=100,000/mcL, and the participant must have been independent of transfusions for at least 1 week before each assessment. There was no duration requirement for confirmation of this designation and Morphologic CR without the requirement of platelet count >=100,000/mcL. | The primary population for all efficacy analyses was the ITT population defined as all participant randomly allocated to a treatment arm. | Posted | Number | percentage of participants | Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cytarabine or Supportive Care | Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.) | 162 | 237 | 231 | 237 | ||
| EG001 | Dacogen (Decitabine) Only | 20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks. | 190 | 238 | 237 | 238 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations |
| |||
| Sepsis | Infections and infestations |
| |||
| Septic Shock | Infections and infestations |
| |||
| Bronchopneumonia | Infections and infestations |
| |||
| Febrile Neutropenia | Blood and lymphatic system disorders |
| |||
| Thrombocytopenia | Blood and lymphatic system disorders |
| |||
| Anemia | Blood and lymphatic system disorders |
| |||
| Neutropenia | Blood and lymphatic system disorders |
| |||
| Disease Progression | General disorders |
| |||
| Pyrexia | General disorders |
| |||
| General Physical Health Deterioration | General disorders |
| |||
| Atrial Fibrillation | Cardiac disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders |
| |||
| Disease Progression | General disorders |
| |||
| Peripheral Edema | General disorders |
| |||
| Pneumonia | Infections and infestations |
| |||
| Urinary Tract Infection | Infections and infestations |
| |||
| Oral Herpes | Infections and infestations |
| |||
| Thrombocytopenia | Blood and lymphatic system disorders |
| |||
| Anemia | Blood and lymphatic system disorders |
| |||
| Febrile Neutropenia | Blood and lymphatic system disorders |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Inc. | 1-888-274-2378 | esi_medinfo@eisai.com |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003561 | Cytarabine |
| D010166 | Palliative Care |
| D000077209 | Decitabine |
| D012847 | Single Person |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D012263 | Ribonucleosides |
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
|
|
|