Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-12 @ 11:04 PM
Study NCT ID:
NCT03063203
Status:
TERMINATED
Last Update Posted:
2022-06-02
First Post:
2017-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077209', 'term': 'Decitabine'}], 'ancestors': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jwelch@wustl.edu', 'phone': '314-362-2626', 'title': 'John Welch, M.D., Ph.D.', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).', 'eventGroups': [{'id': 'EG000', 'title': 'Decitabine', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 17, 'seriousNumAtRisk': 17, 'deathsNumAffected': 15, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chest tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Knots', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Localized edema - right breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cellulitis on shin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Staphylococcus epidermis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cardiac troponin I increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hip pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hallucinations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Oily skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Traumatic fat necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash maculopapular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Bacteremia streptococcus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Facial cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival of Participants With TP53 Mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Decitabine', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '244', 'groupId': 'OG000', 'lowerLimit': '116', 'upperLimit': '390'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year', 'description': '* Overall survival (OS) is defined as the time from enrollment to death due to any cause. For a patient who is not known to be alive at the end of study follow up, observation of OS is censored on the date the patient was last known to be alive\n* To be evaluable for this outcome measure the participant would have to have received at least one dose of decitabine', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Responding TP53 Mutated Patients (CR, CRi)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Decitabine', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': '* Complete remission (CR) - Defined as bone marrow blasts \\<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \\>1.0 x 109/L (1,000/μL); platelet count \\>100 x 109/L (100,000/μL).\n* Complete remission with incomplete hematologic recovery (CRi): All CR criteria except for residual neutropenia - \\<1.0 x 109/L (1,000/μL) or thrombocytopenia -\\<100 x 109/L (100,000/μL)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Stem Cell Transplant Among Participants Who Are Suitable Candidates for Transplant and Have an Identified Donor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Decitabine', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000', 'lowerLimit': '77', 'upperLimit': '163'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': '* Document the number of days that it takes each participant to reach transplant\n* Transplant eligible participants are those who achieve complete remission (CR), cytogenetic complete remission (CRc), complete remission with incomplete hematologic recovery (CRi), or morphologic leukemia free state (mLFS) per 2017 ELN AML Recommendations.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Time to Leukemia Relapse (TTLR) in Non-transplant Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Decitabine', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '308', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '374'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 years', 'description': '-Recurrence/morphologic relapse - Defined as relapse following complete remission is defined as reappearance of blasts in the blood or the finding of ≥ 5% blasts in the bone marrow, not attributable to any other cause. New dysplastic changes is considered relapse. If there are no blasts in the peripheral blood and 5-20% blasts in the bone marrow, bone marrow biopsy should be repeated in \\> 1 week to confirm relapse.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Event-free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Decitabine', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '354'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 year', 'description': '-Event-free survival is defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, death due to any cause, or loss to follow up.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Number of Hospital Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Decitabine', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '28'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During cycles 1 and 2 (60 days)', 'description': '-Document number of hospital days that each participant stays and obtain average for all evaluable participants', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Response Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphologically Evident Disease', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}, {'id': 'OG001', 'title': 'Molecularly Detected Disease', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}], 'classes': [{'title': 'Complete remission with incomplete hematologic recovery (CRi)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Morphologic leukemia free state (mLFS)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Stable Disease (SD)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Progressive disease (PD)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 12 weeks', 'description': '* Morphologically evident disease (\\>5% blasts by cytomorphology)\n* Molecularly detected disease (disease detected with flow cytometry, cytogenetic, or mutational analysis if ≤ 5% blasts by cytomorphology)\n* Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Response was not evaluable for 2 patients with molecularly evident disease as their samples were hemodilute. Response was not evaluable for 1 patient with molecularly detected disease as their sample was hemodilute.'}, {'type': 'SECONDARY', 'title': 'Survival Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphologically Evident Disease', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}, {'id': 'OG001', 'title': 'Molecularly Detected Disease', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000', 'lowerLimit': '58', 'upperLimit': '390'}, {'value': '336', 'groupId': 'OG001', 'lowerLimit': '61', 'upperLimit': '557'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 years', 'description': '* Morphologically evident disease (\\>5% blasts by cytomorphology)\n* Molecularly detected disease (disease detected with flow cytometry, cytogenetic, or mutational analysis with ≤ 5% blasts by cytomorphology)', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With de Novo AML', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}, {'id': 'OG001', 'title': 'Patients With Secondary AML', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}, {'id': 'OG002', 'title': 'Patients With Treatment Related AML', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}], 'classes': [{'title': 'Complete remission with incomplete hematologic recovery (CRi)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Morphologic leukemia free state (mLFS)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Stable Disease (SD)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Progressive disease (PD)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 12 weeks', 'description': '-Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients with de novo AML were not evaluable for this outcome measure because the samples were hemodilute. 1 patient with treatment related AML was not evaluable for this outcome measure because the samples were hemodilute.'}, {'type': 'SECONDARY', 'title': 'Survival Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With de Novo AML', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}, {'id': 'OG001', 'title': 'Patients With Secondary AML', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}, {'id': 'OG002', 'title': 'Patients With Treatment Related AML', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000', 'lowerLimit': '106', 'upperLimit': '557'}, {'value': '235', 'groupId': 'OG001', 'lowerLimit': '116', 'upperLimit': '354'}, {'value': '244', 'groupId': 'OG002', 'lowerLimit': '58', 'upperLimit': '454'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 years', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Response Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}, {'id': 'OG001', 'title': 'Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}], 'classes': [{'title': 'Complete remission with incomplete hematologic recovery (CRi)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Morphologic leukemia free state (mLFS)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stable Disease (SD)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Progressive disease (PD)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': '-Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Response was not evaluable for 3 patients with presence of cytogenetic abnormalities in addition to TP53 mutations as their response samples were hemodilute.'}, {'type': 'SECONDARY', 'title': 'Survival Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}, {'id': 'OG001', 'title': 'Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000', 'lowerLimit': '116', 'upperLimit': '390'}, {'value': 'NA', 'comment': 'The median survival with 95% confidence interval was not estimable due to an insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 years', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Number of Hospital Stays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Decitabine', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During cycles 1 and 2 (60 days)', 'description': '-Document number of hospital days that each participant stays and obtain median for all evaluable participants', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Decitabine', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Chose alternative therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Decitabine', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000', 'lowerLimit': '43', 'upperLimit': '74'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-01', 'size': 929067, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-23T09:35', 'hasProtocol': True}, {'date': '2020-12-02', 'size': 324752, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-06-01T10:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Futility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2017-02-20', 'resultsFirstSubmitDate': '2022-01-24', 'studyFirstSubmitQcDate': '2017-02-20', 'lastUpdatePostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-18', 'studyFirstPostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival of Participants With TP53 Mutation', 'timeFrame': '1 year', 'description': '* Overall survival (OS) is defined as the time from enrollment to death due to any cause. For a patient who is not known to be alive at the end of study follow up, observation of OS is censored on the date the patient was last known to be alive\n* To be evaluable for this outcome measure the participant would have to have received at least one dose of decitabine'}], 'secondaryOutcomes': [{'measure': 'Percentage of Responding TP53 Mutated Patients (CR, CRi)', 'timeFrame': '12 weeks', 'description': '* Complete remission (CR) - Defined as bone marrow blasts \\<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \\>1.0 x 109/L (1,000/μL); platelet count \\>100 x 109/L (100,000/μL).\n* Complete remission with incomplete hematologic recovery (CRi): All CR criteria except for residual neutropenia - \\<1.0 x 109/L (1,000/μL) or thrombocytopenia -\\<100 x 109/L (100,000/μL)'}, {'measure': 'Time to Stem Cell Transplant Among Participants Who Are Suitable Candidates for Transplant and Have an Identified Donor', 'timeFrame': '12 weeks', 'description': '* Document the number of days that it takes each participant to reach transplant\n* Transplant eligible participants are those who achieve complete remission (CR), cytogenetic complete remission (CRc), complete remission with incomplete hematologic recovery (CRi), or morphologic leukemia free state (mLFS) per 2017 ELN AML Recommendations.'}, {'measure': 'Median Time to Leukemia Relapse (TTLR) in Non-transplant Patients', 'timeFrame': '2 years', 'description': '-Recurrence/morphologic relapse - Defined as relapse following complete remission is defined as reappearance of blasts in the blood or the finding of ≥ 5% blasts in the bone marrow, not attributable to any other cause. New dysplastic changes is considered relapse. If there are no blasts in the peripheral blood and 5-20% blasts in the bone marrow, bone marrow biopsy should be repeated in \\> 1 week to confirm relapse.'}, {'measure': 'Event-free Survival (EFS)', 'timeFrame': '2 year', 'description': '-Event-free survival is defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, death due to any cause, or loss to follow up.'}, {'measure': 'Average Number of Hospital Days', 'timeFrame': 'During cycles 1 and 2 (60 days)', 'description': '-Document number of hospital days that each participant stays and obtain average for all evaluable participants'}, {'measure': 'Response Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment', 'timeFrame': 'Through 12 weeks', 'description': '* Morphologically evident disease (\\>5% blasts by cytomorphology)\n* Molecularly detected disease (disease detected with flow cytometry, cytogenetic, or mutational analysis if ≤ 5% blasts by cytomorphology)\n* Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations'}, {'measure': 'Survival Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment', 'timeFrame': '2 years', 'description': '* Morphologically evident disease (\\>5% blasts by cytomorphology)\n* Molecularly detected disease (disease detected with flow cytometry, cytogenetic, or mutational analysis with ≤ 5% blasts by cytomorphology)'}, {'measure': 'Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML', 'timeFrame': 'Through 12 weeks', 'description': '-Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations'}, {'measure': 'Survival Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML', 'timeFrame': '2 years'}, {'measure': 'Response Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations', 'timeFrame': '12 weeks', 'description': '-Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations'}, {'measure': 'Survival Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations', 'timeFrame': '2 years'}, {'measure': 'Median Number of Hospital Stays', 'timeFrame': 'During cycles 1 and 2 (60 days)', 'description': '-Document number of hospital days that each participant stays and obtain median for all evaluable participants'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia', 'Acute Myeloid Leukemia, Relapsed, Adult']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators seek to determine whether decitabine therapy can improve outcomes, specifically overall survival this selected subset of acute myeloid leukemia (AML) patients with the poorest prognosis based on refractoriness to induction treatment and high risk genetic mutations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TP53 mutant AML. The presence of a TP53 mutation should be determined by Genoptix (or institutional preferred equivalent assay). Detection of a TP53 mutation at the time of initial diagnosis is sufficient for enrollment at the time of relapsed/refractory disease. Detection of a TP53 mutation in either the peripheral blood or bone marrow is adequate for enrollment. Alternatively, patients who have not had TP53 mutation analysis performed, but who have \\> 20% TP53 positive cells by immunohistochemistry detected on a bone marrow aspirate may also be enrolled,29 provided that mutation analysis is requested at the time of enrollment.\n* Relapsed/refractory AML following 7+3 (or similar cytarabine containing induction chemotherapy for AML) disease detected by one of the following methods:\n\n * bone marrow blasts \\> 5%, or\n * Hematologics flow cytometry assay (threshold \\> 0.5%) (alternative equivalent assay may be substituted), or\n * Persistent cytogenetic abnormality (e.g. del5, del17p, etc), by FISH or conventional karotyping, or\n * Persistent TP53 mutation (at least 5 variant reads with at least 50x coverage) determined by Genoptix (or institutional preferred equivalent assay).\n* Patients with \\> 10% blasts on a day +14 bone marrow biopsy following 7+3 may either be enrolled or may be treated with a course of standard re-induction (e.g. 5+2 or similar) and then re-evaluated for response. Eligible patients will meet any of the above criteria on a subsequent biopsy.\n* Bone marrow and organ function as defined below:\n\n * Peripheral white blood cell count \\< 50,000/mcl (patients may receive hydroxyurea as necessary for cytoreduction),\n * Total bilirubin \\< 1.5 x upper limit of normal,\n * AST and ALT \\< 2.5 x upper limit of normal,\n * Serum creatinine \\< 2.0 x upper limit of normal, and,\n* At least 18 years of age.\n* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable\n* Performance status ≤ 3\n\nExclusion Criteria:\n\n* Prior treatment with either decitabine or azacitidine or an investigational agent\n* Acute promyelocytic leukemia with PML-RARA or t(15;17).\n* History of HIV, Hepatitis B, or Hepatitis C infection.\n* Concurrent illness including, but not limited to, ongoing uncontrolled infection, symptomatic NYHA class 3 or 4 congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n* Radiation therapy within 14 days of enrollment.\n* Chemotherapy administration in the 7 days preceding enrollment with the exception of hydroxyurea, which can be continued until Cycle 2. A washout period for oral tyrosine kinase inhibitors (e.g. Jakafi, etc) is not required, although tyrosine kinase inhibitors therapy must be discontinued prior to enrollment.\n* Malignancies (other than AML) requiring active therapy or diagnosed within the last year, with the exception of non-melanoma skin cancer which can be treated or in situ malignancies (such as cervical, breast, prostate, etc.)\n* Currently receiving any other investigational agents.\n* Known central nervous system (CNS) leukemia or testicular involvement of leukemia\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine or other agents used in the study.\n* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 7 days of study entry.'}, 'identificationModule': {'nctId': 'NCT03063203', 'briefTitle': 'Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'An Open Label, Multicenter, Phase II Trial Testing Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': '201911185-1001'}, 'secondaryIdInfos': [{'id': '3P50CA171963-06S1', 'link': 'https://reporter.nih.gov/quickSearch/3P50CA171963-06S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Decitabine', 'description': '* Cycle 1: All patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle\n* Cycle 2: Patients with bone marrow blast counts \\< 5% may receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.\n* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle', 'interventionNames': ['Drug: Decitabine', 'Procedure: Bone marrow biopsy/aspirate', 'Procedure: Peripheral blood draw', 'Procedure: Skin biopsy', 'Procedure: Buccal swab']}], 'interventions': [{'name': 'Decitabine', 'type': 'DRUG', 'otherNames': ["5-aza-2'-deoxycytidine"], 'description': "* After 2 cycles, patients with progressive disease or relapse (a clear progression with at least \\>20% bone marrow blasts and an increase of at least 50% from prior biopsy) should be removed from protocol and proceed to salvage treatment according to center preference\n* Transplant eligible patients who achieve CR, CRc, or CRi, after 3 cycles with a suitable donor will proceed to conditioning regimen and transplant\n* Transplant eligible patients with PR after 3 cycles may be removed from protocol and proceed to salvage treatment according to center preference\n* Transplant eligible patients with a suitable donor who achieve mLFS, CR, CRc, or CRi, may proceed to transplant after at 3 cycles\n* Transplant ineligible patients with (CR, CRc or CRi, PR) will continue on maintenance doses\n* Transplant ineligible patient with SD after cycle 4 may be removed from protocol and proceed to alternative treatment or continue on protocol according to treating physician's preference.", 'armGroupLabels': ['Decitabine']}, {'name': 'Bone marrow biopsy/aspirate', 'type': 'PROCEDURE', 'description': '* Baseline, Cycle 1 Day 10, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, and Progression or relapse\n* Biopsy/aspirate on Cycle 1 Day 10 is for participants enrolled at Washington University only\n* Biopsy/aspirate on Cycle 2 Day 28 is at the discretion of the treating physician', 'armGroupLabels': ['Decitabine']}, {'name': 'Peripheral blood draw', 'type': 'PROCEDURE', 'description': '-Baseline, Cycle 1 Day 10, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, and Progression/Relapse', 'armGroupLabels': ['Decitabine']}, {'name': 'Skin biopsy', 'type': 'PROCEDURE', 'description': '* Optional but if refuse skin biopsy then participant can provided buccal swab\n* There is no required time frame for this sample - it may have been collected months or even years prior to the first dose of decitabine\n* If WBC at time of enrollment is \\>30,000/µl, skin biopsy should be collected at the time of C1D28 bone marrow biopsy or thereafter', 'armGroupLabels': ['Decitabine']}, {'name': 'Buccal swab', 'type': 'PROCEDURE', 'description': '-Baseline (if skin biopsy declined) and Cycle 2 Day 28', 'armGroupLabels': ['Decitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'John Welch, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Pharmaceuticals', 'class': 'INDUSTRY'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}