Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-02-02 @ 12:01 AM
Study NCT ID:
NCT01794702
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2013-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077209', 'term': 'Decitabine'}, {'id': 'D015255', 'term': 'Idarubicin'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D000077866', 'term': 'Clofarabine'}], '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'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D000227', 'term': 'Adenine Nucleotides'}, {'id': 'D011685', 'term': 'Purine Nucleotides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'njain@mdanderson.org', 'phone': '713-745-6080', 'title': 'Nitin Jain, MD./Associate Professor', 'organization': 'The University of Texas MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 years', 'description': 'All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol.\n\nPeriod 1 Dose level 1 - Clofarabine 15mg/m\\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\\^2 daily x 3 days (days 6-8)', 'eventGroups': [{'id': 'EG000', 'title': 'Period 1', 'description': 'Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin\n\nPhase I - Decitabine 20 mg/m\\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\\^2 by vein for approximately 2 hours daily for 5 days (days 6-10)\n\nClofarabine: Phase I Starting Dose - 15 mg/m\\^2 by vein daily for 4 days (days 6-9)', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 17, 'seriousNumAtRisk': 18, 'deathsNumAffected': 1, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Period 2', 'description': 'Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin\n\nPhase I - Decitabine 20 mg/m\\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\\^2 by vein for approximately 2 hours daily for 5 days (days 6-10)\n\nClofarabine: Phase I Dose level -1 - 15 mg/m\\^2 by vein daily for 3 days (days 6-9)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin', 'description': 'Phase II - Decitabine 20 mg/m\\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\\^2 by vein for approximately 2 hours daily for 5 days (days 6-10)\n\nPhase II - Clofarabine 15 mg/m2 by vein over approximately 1 hour for 4 days (days 6-9).', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 27, 'seriousNumAtRisk': 46, 'deathsNumAffected': 5, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Elevated Transaminases', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Elevated Transaminases', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastric Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Left Ventricular Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutropenic Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 24, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 38, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abcess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bronchopulmonary Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Intracranial Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Typhlitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD) of Clofarabine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1', 'description': 'Clofarabine + Cytarabine + Decitabine + Idarubicin\n\nPhase I - Decitabine 20 mg/m\\^2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\\^2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\\^2 by vein over approximately 2 hours daily for 5 days (days 6-10)\n\nClofarabine 15 mg/m\\^2 by vein over approximately 1 hour daily'}, {'id': 'OG001', 'title': 'Period 2', 'description': 'Clofarabine + Cytarabine + Decitabine + Idarubicin\n\nPhase I - Decitabine 20 mg/m\\^2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\\^2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\\^2 by vein over approximately 2 hours daily for 5 days (days 6-10)\n\nClofarabine 15 mg/m\\^2 by vein over approximately 1 hour daily'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After second, 33 day cycle', 'description': 'Maximum tolerated dose (MTD) defined as the highest dose schedule in which 6 patients were treated with at most 1 experiencing a dose-limiting toxicity (DLT). Clofarabine 15 mg/m2 IV over approximately 1 hour daily (number of days selected based on Phase I portion).', 'unitOfMeasure': 'mg/m^2 x 4 days (6-9)', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol.\n\nPeriod 1: Dose level 1 - Clofarabine 15mg/m\\^2 daily x 4 days (days 6-9) Period 2: Dose level-1 - Clofarabine 15mg/m\\^2 daily x 3 days (days 6-8)'}, {'type': 'PRIMARY', 'title': 'Number of Participants With a Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin', 'description': 'Phase II - Decitabine 20 mg/m\\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\\^2 by vein for approximately 2 hours daily for 5 days (days 6-10)\n\nPhase II - Clofarabine 15 mg/m2 by vein over approximately 1 hour for 4 days (days 6-9).'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '56 days', 'description': 'Primary endpoint is overall response defined as the best response either complete response, complete remission without platelet recovery, or complete remission without incomplete blood count recovery within 56 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One of the 47 participants on the Phase II portion of this study who received study medication was not evaluable for response.'}, {'type': 'SECONDARY', 'title': 'To Determine the Disease-free Survival (DFS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin', 'description': 'Phase II - Decitabine 20 mg/m\\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\\^2 by vein for approximately 2 hours daily for 5 days (days 6-10)\n\nPhase II - Clofarabine 15 mg/m2 by vein over approximately 1 hour for 4 days (days 6-9).'}], 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '33'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 years after participants off study date', 'description': 'Time from date of treatment start until the date of first objective documentation of return of disease.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One of the 47 participants on the Phase II portion of this study who received study medication was not evaluable for response.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin', 'description': 'Phase II - Decitabine 20 mg/m\\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\\^2 by vein for approximately 2 hours daily for 5 days (days 6-10)\n\nPhase II - Clofarabine 15 mg/m2 by vein over approximately 1 hour for 4 days (days 6-9).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 years after participants off study date', 'description': 'Time from date of treatment start until date of death due to any cause or last Follow-up.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One of the 47 participants on the Phase II portion of this study who received study medication was not evaluable for response.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Period 1', 'description': 'Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin\n\nPhase I - Decitabine 20 mg/m\\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\\^2 by vein for approximately 2 hours daily for 5 days (days 6-10)\n\nClofarabine: Phase I Starting Dose - 15 mg/m\\^2 by vein daily for 4 days (days 6-9)'}, {'id': 'FG001', 'title': 'Period 2', 'description': 'Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin\n\nPhase I - Decitabine 20 mg/m\\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\\^2 by vein for approximately 2 hours daily for 5 days (days 6-10)\n\nClofarabine: Phase I Dose level -1 - 15 mg/m\\^2 by vein daily for 3 days (days 6-9)'}, {'id': 'FG002', 'title': 'Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin', 'description': 'Phase II - Decitabine 20 mg/m\\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\\^2 by vein for approximately 2 hours daily for 5 days (days 6-10)\n\nPhase II - Clofarabine 15 mg/m\\^2 by vein over approximately 1 hour for 4 days (days 6-9).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment Period: 1/2013 to 01/2018', 'preAssignmentDetails': 'All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol.\n\nPeriod 1: Dose level 1 - Clofarabine 15mg/m\\^2 daily x 4 days (days 6-9) Period 2: Dose level-1 - Clofarabine 15mg/m\\^2 daily x 3 days (days 6-8)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Period 1', 'description': 'Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin\n\nPhase I - Decitabine 20 mg/m\\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\\^2 by vein for approximately 2 hours daily for 5 days (days 6-10)\n\nClofarabine: Phase I Starting Dose - 15 mg/m\\^2 by vein daily for 4 days (days 6-9)'}, {'id': 'BG001', 'title': 'Period 2', 'description': 'Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin\n\nPhase I - Decitabine 20 mg/m\\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\\^2 by vein for approximately 2 hours daily for 5 days (days 6-10)\n\nClofarabine: Phase I Dose -1 - 15 mg/m\\^2 by vein daily for 3 days (days 6-9)'}, {'id': 'BG002', 'title': 'Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin', 'description': 'Phase II - Decitabine 20 mg/m\\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\\^2 by vein for approximately 2 hours daily for 5 days (days 6-10)\n\nPhase II - Clofarabine 15 mg/m2 by vein over approximately 1 hour for 4 days (days 6-9).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol.\n\nPeriod 1 Dose level 1 - Clofarabine 15mg/m\\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\\^2 daily x 3 days (days 6-8)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-09-02', 'size': 392645, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-15T10:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Starting with Dose level 1, the participants were enrolled by cohort of 3. Once the DLT assessment is completed, another cohort of 3 patients will be enrolled. If at any time, we see more than 30% patients experiencing DLT, we will de-escalate to dose level (-1).\n\nPeriod 1: Dose level 1 Clofarabine 15mg/m\\^2 daily x 4 days (days 6-9)\n\nPeriod 2: Dose level-1 Clofarabine 15mg/m\\^2 daily x 3 days (days 6-8)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-28', 'studyFirstSubmitDate': '2013-02-15', 'resultsFirstSubmitDate': '2019-02-08', 'studyFirstSubmitQcDate': '2013-02-15', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-16', 'studyFirstPostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) of Clofarabine', 'timeFrame': 'After second, 33 day cycle', 'description': 'Maximum tolerated dose (MTD) defined as the highest dose schedule in which 6 patients were treated with at most 1 experiencing a dose-limiting toxicity (DLT). Clofarabine 15 mg/m2 IV over approximately 1 hour daily (number of days selected based on Phase I portion).'}, {'measure': 'Number of Participants With a Response', 'timeFrame': '56 days', 'description': 'Primary endpoint is overall response defined as the best response either complete response, complete remission without platelet recovery, or complete remission without incomplete blood count recovery within 56 days.'}], 'secondaryOutcomes': [{'measure': 'To Determine the Disease-free Survival (DFS).', 'timeFrame': 'Up to 2 years after participants off study date', 'description': 'Time from date of treatment start until the date of first objective documentation of return of disease.'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 2 years after participants off study date', 'description': 'Time from date of treatment start until date of death due to any cause or last Follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leukemia', 'Acute Leukemia', 'Acute myelogenous leukemia', 'AML', 'Acute lymphoblastic leukemia', 'ALL', 'Maximum Tolerated Dose', 'MTD', 'Response Rate', 'Decitabine', 'Dacogen', 'Idarubicin', 'Idamycin', 'Cytarabine', 'Ara-C', 'Cytosar', 'DepoCyt', 'Cytosine Arabinosine Hydrochloride'], 'conditions': ['Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of Phase I of this clinical research study is find the highest tolerable dose of clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with acute leukemia.\n\nThe goal of Phase II of this study is to learn if decitabine followed by the combination of clofarabine, idarubicin, and cytarabine can help to control acute leukemia. The safety of this drug combination will also be studied.\n\nDecitabine and idarubicin are designed to damage the DNA (the genetic material of cells). This may cause cancer cells to die.\n\nClofarabine is designed to interfere with the growth and development of cancer cells.\n\nCytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.', 'detailedDescription': 'Study Groups:\n\nIf you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 3 groups of 6 participants will be enrolled in the Phase I portion of the study. Up to 74 participants will be enrolled in Phase II.\n\nPhase I:\n\nIf you are enrolled in the Phase I portion, the number of days of clofarabine you receive will depend on when you joined this study. The first group of participants will receive clofarabine for 4 days. Each new group will receive clofarabine for the same number of days, if no intolerable side effects were seen. The number of days may be reduced to 3. The clofarabine dose per day is the same from group to group.\n\nAll participants will receive the same dose level of decitabine, idarubicin and cytarabine.\n\nPhase II:\n\nIf you are enrolled in the Phase II portion, you will receive decitabine, idarubicin, and cytarabine. You will receive clofarabine for the highest number of days that was tolerated in the Phase I portion.\n\nAll participants will receive the same dose level of decitabine, idarubicin, cytarabine, and clofarabine.\n\nStudy Drug Administration:\n\nEach study drug cycle is 33 days. The first cycle of study drugs is called Induction. If the doctor thinks it is needed, you will have up to 2 Induction cycles.\n\nPhase I (Induction):\n\nOn Days 1-5 of each cycle, you will receive decitabine 1 time a day by vein over about 1 hour.\n\nOn Days 6-10 of each cycle:\n\n* You will receive cytarabine 1 time a day by vein over about 2 hours.\n* On Days 6-8 only, you will receive idarubicin 1 time a day by vein over about 30 minutes.\n* You will receive clofarabine 1 time a day by vein over about 1 hour on Days 6-8 or 6-9, depending on when you join the study.\n\nIf the doctor thinks it is needed, your dose level will be reduced after Induction.\n\nIf the doctor thinks it is needed, you may receive fewer days of treatment in the Induction cycle(s).\n\nPhase II (Induction):\n\nOn Days 1-5 of each cycle, you will receive decitabine 1 time a day by vein over about 1 hour.\n\nOn Days 6-10 of each cycle:\n\n* You will receive cytarabine 1 time a day by vein over about 2 hours.\n* On Days 6-8 only, you will receive idarubicin 1 time a day by vein over about 30 minutes.\n* You will receive clofarabine 1 time a day by vein over about 1 hour on Days 6-8 or 6-9, depending on the highest number of days clofarabine was tolerated in the Phase I portion of the study.\n\nIf the doctor thinks it is needed, your dose level will be reduced after Induction.\n\nIf the doctor thinks it is needed, you may receive fewer days of treatment in the Induction cycle(s).\n\nPhases I and II (Consolidation):\n\nIf the disease responds to the study drugs, you may receive up to 6 more study drug cycles. This is called Consolidation.\n\nOn Days 1-5 of each cycle:\n\n°You will receive decitabine 1 time a day by vein over 1 hour.\n\nOn Days 6-8 of each cycle:\n\n* You will receive cytarabine 1 time a day by vein over about 2 hours.\n* You will receive clofarabine 1 time a day by vein over about 1 hour.\n* On Days 6-7 only, you will receive idarubicin 1 time a day by vein over about 30 minutes.\n\nIf the doctor thinks it is needed, you may receive fewer days of treatment in the Consolidation cycles.\n\nStudy Visits:\n\nBefore the start of each cycle, you will have a physical exam, including measurement of your vital signs.\n\nEvery 3-7 days, blood (about 2 teaspoons) will be drawn for routine tests.\n\nOn Day 33 of every 2-3 cycles (+/- 7 days), if the doctor thinks it is needed, you will have a bone marrow aspirate to check the status of the disease. To collect a bone marrow aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.\n\nLength of Treatment:\n\nYou may continue taking the study drugs for up to 8 cycles. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.\n\nYour participation on the study will be over once you have completed the long-term follow-up.\n\nLong-term Follow-up:\n\nEvery 3 months for 1 year after your last study drug dose, the study staff will call you and ask how you are feeling, about any side effects you may be having, and about any other drugs you may be taking. These calls should last about 5 minutes each.\n\nThis is an investigational study. Decitabine is FDA approved and commercially available to treat myelodysplastic syndrome (MDS). Clofarabine is FDA approved and commercially available to treat ALL in children. Idarubicin and cytarabine are FDA approved and commercially available to treat AML. The study drug combination is investigational.\n\nUp to 92 participants will be enrolled in this study. All will take part at MD Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Sign an IRB-approved informed consent document.\n2. Age \\>/= 18 years and \\<65 years.\n3. Diagnosis of AML \\[other than acute promyelocytic leukemia\\] with refractory/relapsed disease (Patients must be primary refractory, in relapse 1, or in relapse 2). NOTE: Patients with AML arising from prior MDS or MPN would be eligible even if they have not received treatment for the AML. NOTE: Patients with relapsed/refractory ALL would also be eligible for the phase II part of the study. NOTE: Use of hydroxyurea and/or up to 4 doses of cytarabine, for emergent cytoreduction is allowed\n4. ECOG performance status of \\</=2 at study entry.\n5. Organ function as defined below (unless due to leukemia):Serum creatinine \\</= 3 mg/dL;Total bilirubin \\</= 2.5 mg/dL; ALT (SGPT) \\</= 3 x ULN or \\</= 5 x ULN if related to disease\n6. Cardiac ejection fraction ≥ 40% (by either cardiac ECHO or MUGA scan)\n7. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.\n\nExclusion Criteria:\n\n1. Breast feeding women\n2. Patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible).\n3. Patients with active secondary malignancy will not be eligible unless approved by the PI.\n4. NOTE: Prior therapy with decitabine, clofarabine, idarubicin, or cytarabine is allowed, unless the prior therapy is identical to the schema/schedule proposed in this study'}, 'identificationModule': {'nctId': 'NCT01794702', 'briefTitle': 'Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Phase I/II Study of Decitabine (DAC) Followed by Clofarabine, Idarubicin, and Cytarabine (CIA) in Acute Leukemia', 'orgStudyIdInfo': {'id': '2012-1064'}, 'secondaryIdInfos': [{'id': 'NCI-2013-00548', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clofarabine + Cytarabine + Decitabine + Idarubicin', 'description': 'Phase I - Decitabine 20 mg/m2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 6-10)\n\nPhase II - Clofarabine 15 mg/m2 by vein over approximately 1 hour daily (number of days selected based on Phase I portion).\n\nDecitabine 20 mg/m2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 6-10)', 'interventionNames': ['Drug: Decitabine', 'Drug: Idarubicin', 'Drug: Cytarabine', 'Drug: Clofarabine']}], 'interventions': [{'name': 'Decitabine', 'type': 'DRUG', 'otherNames': ['Dacogen'], 'description': 'Phase I and II - 20 mg/m2 by vein daily for 5 days (days 1-5)', 'armGroupLabels': ['Clofarabine + Cytarabine + Decitabine + Idarubicin']}, {'name': 'Idarubicin', 'type': 'DRUG', 'otherNames': ['Idamycin'], 'description': 'Phase I and II - 10 mg/m2 by vein daily for 3 days (days 6-8)', 'armGroupLabels': ['Clofarabine + Cytarabine + Decitabine + Idarubicin']}, {'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['Ara-C', 'Cytosar', 'DepoCyt', 'Cytosine Arabinosine Hydrochloride'], 'description': 'Phase I and II - 1 g/m2 by vein daily for 5 days (days 6-10)', 'armGroupLabels': ['Clofarabine + Cytarabine + Decitabine + Idarubicin']}, {'name': 'Clofarabine', 'type': 'DRUG', 'otherNames': ['Clofarex', 'Clolar'], 'description': 'Phase I Starting Dose - 15 mg/m2 by vein daily for 4 days (days 6-9)\n\nPhase II Starting Dose - Maximum tolerated dose from Phase I (number of days selected based on Phase I portion).', 'armGroupLabels': ['Clofarabine + Cytarabine + Decitabine + Idarubicin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Nitin Jain, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}