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 estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine | Drug | 20 mg/m^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response = Morphologic Complete Remission (mCR) | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eisai US Medical Services | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duarte | California | 91010 | United States | |||
Not provided
| Label | URL |
|---|---|
| Official website of MGI PHARMA, Inc. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Decitabine 20 mg/m2 Intravenous | Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Decitabine 20 mg/m2 Intravenous | Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Complete Response = Morphologic Complete Remission (mCR) | Intent-to-Treat (ITT) | Posted | Number | Participants | 1 year |
|
|
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 | Decitabine 20 mg/m2 Intravenous | Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Call Center | Eisai Inc. | 888-422-4743 |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Los Angeles |
| California |
| 90095-1678 |
| United States |
| St Louis | Missouri | 63110 | United States |
| Withdrawal by Subject |
|
| Physician Decision |
|
| Patient not eligible for study |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 40 |
| 55 |
| 55 |
| 55 |
| Febrile Neutropenia | Blood and lymphatic system disorders |
|
| Neutropenia | Blood and lymphatic system disorders |
|
| Angina Pectoris | Cardiac disorders |
|
| Atrial Fibrillation | Blood and lymphatic system disorders |
|
| Myocardial Infarction | Cardiac disorders |
|
| Caecitis | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Toothache | Gastrointestinal disorders |
|
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Catheter Thrombosis | General disorders |
|
| Chest Pain | General disorders |
|
| Disease Progression | General disorders |
|
| Mucosal Inflammation | General disorders |
|
| Performance Status Decreased | General disorders |
|
| Pyrexia | General disorders |
|
| Cholecystitis Acute | Hepatobiliary disorders |
|
| Hyperbilirubinaemia | Hepatobiliary disorders |
|
| Alpha Haemolytic Streptococcal Infection | Infections and infestations |
|
| Bacteraemia | Infections and infestations |
|
| Catheter Site Infection | Infections and infestations |
|
| Cellulitis | Infections and infestations |
|
| Clostridium Difficile Colitis | Infections and infestations |
|
| Enterocolitis Infectious | Infections and infestations |
|
| Fungaemia | Infections and infestations |
|
| Fungal Sepsis | Infections and infestations |
|
| Gingival Infection | Infections and infestations |
|
| Groin Abscess | Infections and infestations |
|
| Lobar Pneumonia | Infections and infestations |
|
| Pneumonia | Infections and infestations |
|
| Pneumonia Fungal | Infections and infestations |
|
| Pneumonia Klebsiella | Infections and infestations |
|
| Pneumonia Primary Atypical | Infections and infestations |
|
| Pseudomonal Bacteraemia | Infections and infestations |
|
| Sepsis | Infections and infestations |
|
| Staphylococcal Bacteraemia | Infections and infestations |
|
| Staphylococcal Infection | Infections and infestations |
|
| Staphylococcal Sepsis | Infections and infestations |
|
| Streptococcal Bacteraemia | Infections and infestations |
|
| Tonsillitis | Infections and infestations |
|
| Tooth Abscess | Infections and infestations |
|
| Urinary Tract Infection | Infections and infestations |
|
| Urosepsis | Infections and infestations |
|
| Haemolytic Transfusion Reaction | Injury, poisoning and procedural complications |
|
| Subdural Haemorrhage | Injury, poisoning and procedural complications |
|
| Blood Creatinine Increased | Investigations |
|
| Acidosis | Metabolism and nutrition disorders |
|
| Dehydration | Metabolism and nutrition disorders |
|
| Hypokalaemia | Metabolism and nutrition disorders |
|
| Malnutrition | Metabolism and nutrition disorders |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders |
|
| Acute Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Haemorrhage Intracranial | Nervous system disorders |
|
| Mental Status Changes | Psychiatric disorders |
|
| Renal Failure | Renal and urinary disorders |
|
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
|
| Pulmonary Haemorrhage | Respiratory, thoracic and mediastinal disorders |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders |
|
| Dermatitis Allergic | Skin and subcutaneous tissue disorders |
|
| Embolism | Vascular disorders |
|
| Hypotension | Vascular disorders |
|
| Febrile Neutropenia | Blood and lymphatic system disorders |
|
| Leukopenia | Blood and lymphatic system disorders |
|
| Lymphopenia | Blood and lymphatic system disorders |
|
| Neutropenia | Blood and lymphatic system disorders |
|
| Thrombocytopenia | Blood and lymphatic system disorders |
|
| Atrial Fibrillation | Cardiac disorders |
|
| Sinus Tachycardia | Cardiac disorders |
|
| Tachycardia | Cardiac disorders |
|
| Ear Pain | Ear and labyrinth disorders |
|
| Conjuntival Haemorrhage | Eye disorders |
|
| Abdominal Pain | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Gingival Bleeding | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Oral Pain | Gastrointestinal disorders |
|
| Stomatitis | Gastrointestinal disorders |
|
| Toothache | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Asthenia | General disorders |
|
| Catheter Site Pain | General disorders |
|
| Chills | General disorders |
|
| Disease Progression | General disorders |
|
| Fatigue | General disorders |
|
| Mucosal Inflammation | General disorders |
|
| Oedema | General disorders |
|
| Oedema Peripheral | General disorders |
|
| Pain | General disorders |
|
| Performance Status Decreased | General disorders |
|
| Pyrexia | General disorders |
|
| Hyperbilirubinemia | Hepatobiliary disorders |
|
| Bacteraemia | Infections and infestations |
|
| Candidiasis | Infections and infestations |
|
| Cellulitis | Infections and infestations |
|
| Clostridium Difficile Colitis | Infections and infestations |
|
| Pneumonia | Infections and infestations |
|
| Sepsis | Infections and infestations |
|
| Staphylococcal Bacteraemia | Infections and infestations |
|
| Urinary Tract Infection | Infections and infestations |
|
| Contusion | Injury, poisoning and procedural complications |
|
| Procedural Pain | Injury, poisoning and procedural complications |
|
| Alanine Aminotransferase Increased | Investigations |
|
| Blood Alkaline Phosphatase Increased | Investigations |
|
| Blood Creatinine Increased | Investigations |
|
| International Normalised Ratio Increased | Investigations |
|
| Weight Decreased | Investigations |
|
| Anorexia | Metabolism and nutrition disorders |
|
| Decreased Appetite | Metabolism and nutrition disorders |
|
| Fluid Overload | Metabolism and nutrition disorders |
|
| Hyperglycaemia | Metabolism and nutrition disorders |
|
| Hyperkalaemia | Metabolism and nutrition disorders |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders |
|
| Hypocalcaemia | Metabolism and nutrition disorders |
|
| Hypokalaemia | Metabolism and nutrition disorders |
|
| Hypomagnesaemia | Metabolism and nutrition disorders |
|
| Hyponatraemia | Metabolism and nutrition disorders |
|
| Hypophosphataemia | Metabolism and nutrition disorders |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Bone Pain | Musculoskeletal and connective tissue disorders |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders |
|
| Dizziness | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Hypoaesthesia | Nervous system disorders |
|
| Anxiety | Psychiatric disorders |
|
| Depression | Psychiatric disorders |
|
| Insomnia | Psychiatric disorders |
|
| Renal Failure | Renal and urinary disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders |
|
| Paranasal Sinus Hypersecretion | Respiratory, thoracic and mediastinal disorders |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders |
|
| Ecchymosis | Skin and subcutaneous tissue disorders |
|
| Erythema | Skin and subcutaneous tissue disorders |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders |
|
| Night Sweats | Skin and subcutaneous tissue disorders |
|
| Petechiae | Skin and subcutaneous tissue disorders |
|
| Pruritis | Skin and subcutaneous tissue disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Skin Ulcer | Skin and subcutaneous tissue disorders |
|
| Urticaria | Skin and subcutaneous tissue disorders |
|
| Hypertension | Vascular disorders |
|
| Hypotension | Vascular disorders |
|
Not provided
Not provided
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |