Viewing Study NCT01038635

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Ignite Creation Date: 2025-12-24 @ 10:35 PM
Ignite Modification Date: 2025-12-25 @ 8:06 PM
Study NCT ID: NCT01038635
Status: COMPLETED
Last Update Posted: 2017-02-10
First Post: 2009-12-23
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: 5-Azacytidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], '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': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D000077269', 'term': 'Lenalidomide'}], 'ancestors': [{'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': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CR_Study_Registration@mdanderson.org', 'phone': '713-792-7734', 'title': 'Guillermo Garcia-Manero, MD/Professor, Leukemia', 'organization': 'The University of Texas (UT) MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events collected for 28 day cycle, up to 8 weeks following first course.', 'eventGroups': [{'id': 'EG000', 'title': '5-AZA + LEN 10 mg', 'description': 'Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': '5-AZA + LEN 15 mg', 'description': 'Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': '5-AZA + LEN 20 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': '5-AZA + LEN 25 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': '5-AZA + LEN 50 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': '5-AZA + 5 Days LEN 75 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': '5-AZA + 10 Days LEN 75 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 7}, {'id': 'EG007', 'title': 'Phase II: AZA + LEN 50 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.', 'otherNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'seriousNumAffected': 11}, {'id': 'EG008', 'title': 'Phase II: AZA+ LEN 25 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.', 'otherNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alteration in mental status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Aspergillus fungal pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bilateral parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'C. difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Change of smell', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Chest pain unclear etiology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cognitive changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Chronic obstructive pulmonary disease (COPD)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Coronary artery disease (caused chest pain)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Creatine Elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diffuse alveolar hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 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(3.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection, E-coli bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 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{'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Subdural Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Supraventricular Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Tumor Lysis Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Dose Limiting Toxicities for Determining Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With 5-azacytidine (5-AZA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '5-AZA + 5 Days LEN 10 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.'}, {'id': 'OG001', 'title': '5-AZA + 5 Days LEN 15 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.'}, {'id': 'OG002', 'title': '5-AZA + 5 Days LEN 20 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.'}, {'id': 'OG003', 'title': '5-AZA + 5 Days LEN 25 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.'}, {'id': 'OG004', 'title': '5-AZA + 5 Days LEN 50 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.'}, {'id': 'OG005', 'title': '5-AZA + 5 Days LEN 75 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.'}, {'id': 'OG006', 'title': '5-AZA + 10 Days LEN 75 mg 75 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006'], 'paramType': 'Maximal tolerated dose', 'ciNumSides': 'TWO_SIDED', 'paramValue': '75', 'estimateComment': 'Maximal tolerated dose not reached as no dose limiting toxicity documented. MTD considered to be last dose level.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3-8 week cycles, up to 24 weeks', 'description': 'DLT determined only during first course of therapy, at least 28 days from treatment of last participant before a new dose level initiated. All severe (Grade 3-4) non-hematological toxicities that are drug related considered for DLT determination. If 1 participant develops grade III-IV non-hematological toxicity, 3 more will be accrued at that particular dose level. If 2 or more participants develop grade III-IV non-hematologic toxicity, the doses of the combination at which this occurs will be considered too toxic. A total of 10 patients will be treated at the maximally tolerated dose (MTD) of the combination (the dose level below that considered to be too toxic) to confirm its tolerability.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) of Lenalidomide in Combination With 5-azacytidine (5-AZA) in Participants With Leukemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I: 5-AZA + LEN MTD', 'description': '5-Azacytidine 75 mg/m\\^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.'}, {'id': 'OG001', 'title': 'Phase II: 5-AZA + LEN', 'description': 'All subjects received 75mg/m²/day AZA days 1-5 of each 28-day cycle. LEN 50 mg was administered orally for 10 days, with dose later amended to LEN 25 mg daily for 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10\\^9/L or more, platelet count 100 x 10\\^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10\\^9/L, without the need for transfusion of Platelets.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Response: Number of Participants With CR or CRi Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study: 5-AZA + LEN MTD', 'description': 'Combined reporting for all phases, Phase I (5-Azacytidine 75 mg/m\\^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10) and Phase II All subjects received 75mg/m²/day AZA days 1-5 of each 28-day cycle. LEN 50 mg administered orally for 10 days, with dose later amended to LEN 25 mg daily for 5 days.'}], 'classes': [{'title': 'Complete Remission (CR)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Incomplete Count Recover (CRi)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10\\^9/L or more, platelet count 100 x 10\\^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10\\^9/L, without the need for transfusion of Platelets.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '5-AZA + LEN 10 mg', 'description': 'Phase I: 5-Azacytidine (5-AZA) + Lenalidomide (LEN): 5-Azacytidine 75 mg/m\\^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.'}, {'id': 'FG001', 'title': '5-AZA + LEN 15 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.'}, {'id': 'FG002', 'title': '5-AZA + LEN 20 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.'}, {'id': 'FG003', 'title': '5-AZA + LEN 25 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.'}, {'id': 'FG004', 'title': '5-AZA + LEN 50 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.'}, {'id': 'FG005', 'title': '5-AZA + LEN 75 mg for 5 Days', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.'}, {'id': 'FG006', 'title': '5-AZA + LEN 75 mg for 10 Days', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.'}, {'id': 'FG007', 'title': 'Phase II: AZA + LEN 50 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.'}, {'id': 'FG008', 'title': 'Phase II: AZA+ LEN 25 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '20'}, {'groupId': 'FG008', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '15'}, {'groupId': 'FG008', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruitment Period: December 23, 2009 to June 21, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.', 'preAssignmentDetails': 'Of the 94 participants registered, six were ineligible therefore not assigned to groups nor treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '40', 'groupId': 'BG008'}, {'value': '88', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': '5-AZA + LEN 10 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days'}, {'id': 'BG001', 'title': '5-AZA + LEN 15 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days'}, {'id': 'BG002', 'title': '5-AZA + LEN 20 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.'}, {'id': 'BG003', 'title': '5-AZA + LEN 25 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.'}, {'id': 'BG004', 'title': '5-AZA + 50 LEN', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.'}, {'id': 'BG005', 'title': '5-AZA + LEN 75 mg 5 Days', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.'}, {'id': 'BG006', 'title': '5-AZA + LEN 75 mg for 10 Days', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.'}, {'id': 'BG007', 'title': 'Phase II: 5-AZA + LEN 50 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.'}, {'id': 'BG008', 'title': 'Phase II: AZA+ LEN 25 mg', 'description': '5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '79'}, {'value': '54', 'groupId': 'BG001', 'lowerLimit': '54', 'upperLimit': '66'}, {'value': '66', 'groupId': 'BG002', 'lowerLimit': '65', 'upperLimit': '69'}, {'value': '66', 'groupId': 'BG003', 'lowerLimit': '54', 'upperLimit': '71'}, {'value': '71', 'groupId': 'BG004', 'lowerLimit': '65', 'upperLimit': '79'}, {'value': '64', 'groupId': 'BG005', 'lowerLimit': '63', 'upperLimit': '77'}, {'value': '63', 'groupId': 'BG006', 'lowerLimit': '32', 'upperLimit': '70'}, {'value': '72', 'groupId': 'BG007', 'lowerLimit': '36', 'upperLimit': '88'}, {'value': '66', 'groupId': 'BG008', 'lowerLimit': '38', 'upperLimit': '85'}, {'value': '67', 'groupId': 'BG009', 'lowerLimit': '32', 'upperLimit': '88'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '40', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '24', 'groupId': 'BG008'}, {'value': '48', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}, {'value': '37', 'groupId': 'BG008'}, {'value': '80', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}]}]}], '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'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}, {'value': '36', 'groupId': 'BG008'}, {'value': '78', 'groupId': 'BG009'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '40', 'groupId': 'BG008'}, {'value': '88', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline characteristics represented in study phase, Phase I and Phase II separately.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-19', 'studyFirstSubmitDate': '2009-12-23', 'resultsFirstSubmitDate': '2016-12-19', 'studyFirstSubmitQcDate': '2009-12-23', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-19', 'studyFirstPostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Dose Limiting Toxicities for Determining Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With 5-azacytidine (5-AZA)', 'timeFrame': '3-8 week cycles, up to 24 weeks', 'description': 'DLT determined only during first course of therapy, at least 28 days from treatment of last participant before a new dose level initiated. All severe (Grade 3-4) non-hematological toxicities that are drug related considered for DLT determination. If 1 participant develops grade III-IV non-hematological toxicity, 3 more will be accrued at that particular dose level. If 2 or more participants develop grade III-IV non-hematologic toxicity, the doses of the combination at which this occurs will be considered too toxic. A total of 10 patients will be treated at the maximally tolerated dose (MTD) of the combination (the dose level below that considered to be too toxic) to confirm its tolerability.'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR) of Lenalidomide in Combination With 5-azacytidine (5-AZA) in Participants With Leukemia', 'timeFrame': '6 months', 'description': 'Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10\\^9/L or more, platelet count 100 x 10\\^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10\\^9/L, without the need for transfusion of Platelets.'}, {'measure': 'Overall Response: Number of Participants With CR or CRi Response', 'timeFrame': '6 months', 'description': 'Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10\\^9/L or more, platelet count 100 x 10\\^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10\\^9/L, without the need for transfusion of Platelets.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['5-Azacytidine', '5-Aza', 'Lenalidomide', 'Revlimid', 'CC-5103', 'Myelodysplastic Syndrome', 'MDS', 'Acute Myelogenous Leukemia', 'AML'], 'conditions': ['Leukemia']}, 'referencesModule': {'references': [{'pmid': '26687423', 'type': 'DERIVED', 'citation': 'DiNardo CD, Daver N, Jabbour E, Kadia T, Borthakur G, Konopleva M, Pemmaraju N, Yang H, Pierce S, Wierda W, Bueso-Ramos C, Patel KP, Cortes JE, Ravandi F, Kantarjian HM, Garcia-Manero G. Sequential azacitidine and lenalidomide in patients with high-risk myelodysplastic syndromes and acute myeloid leukaemia: a single-arm, phase 1/2 study. Lancet Haematol. 2015 Jan;2(1):e12-20. doi: 10.1016/S2352-3026(14)00026-X. Epub 2014 Dec 22.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of lenalidomide that can be given in combination with azacitidine to patients with MDS or AML.\n\nThe goal of Phase 2 of this study is to learn if the combination dose of azacitidine and lenalidomide found in Phase 1 can help to control MDS and/or AML.\n\nThe safety of this drug combination will be studied in both Phases.', 'detailedDescription': 'The Study Drugs:\n\nAzacitidine is designed to block certain proteins that stop the function of tumor-fighting genes. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better.\n\nLenalidomide is designed to change the immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells.\n\nStudy 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 joined this study. Up to 6 groups of 3-6 participants will be enrolled in the Phase 1 portion of the study, and up to 40 participants will be enrolled in Phase 2.\n\nIf you are enrolled in the Phase 1 portion, the dose of lenalidomide you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of lenalidomide. Each new group will receive a higher dose of lenalidomide than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of lenalidomide is found.\n\nIf you are enrolled in the Phase 2 portion, you will receive lenalidomide at the highest dose that was tolerated in the Phase 1 portion.\n\nAll participants will receive the same dose level of azacitidine.\n\nStudy Drug Administration:\n\nEach study "cycle" will be about 3-8 weeks, depending on how well you tolerate the drugs, any side effects that you may have, and how your blood count and bone marrow recovers.\n\nOn Days 1-5 of every cycle, you will receive azacitidine by vein over 15-30 minutes.\n\nIn order to participate in this study you must register into and follow the requirements of the Revlimid REMS™ program of Celgene Corporation. This program provides education and counseling on the risks of fetal exposure, blood clots and reduced blood counts. You will be required to receive counseling every 28 days during treatment with lenalidomide, follow the pregnancy testing and birth control requirements of the program that are appropriate for you and take telephone surveys regarding your compliance with the program.\n\nIf you are enrolled in Phase 2 of the study, on Days 6-15 of every cycle, you will take capsules of lenalidomide by mouth.\n\nYou should swallow lenalidomide capsules whole with a cup (about 8 ounces) of water at the same time each day. Do not break, chew, or open the capsules. If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose). If you take more than the prescribed dose of lenalidomide, you should seek emergency medical care if needed and contact study staff right away. Any unused lenalidomide should be returned as instructed through the RevAssist® program.\n\nAny woman who can become pregnant should wear gloves if touching the lenalidomide capsules.\n\nYou have been informed of the risk of birth defects. If you are female, you agree not to become pregnant while taking lenalidomide. For this reason, lenalidomide is provided to patients under a special distribution program called Revlimid REMSTM.\n\nYour dose of study drugs may be lowered if you experience side effects.\n\nYou may be given drugs to help prevent side effects, such as nausea, vomiting, and/or diarrhea. The doctor will tell you more about what drugs you may receive.\n\nStudy Visits:\n\nAt every study visit, you will be asked about any other drugs and/or treatments you may be receiving and about any side effects you may be having.\n\nOne (1) time during each week of Cycle 1:\n\n* Your medical history will be recorded.\n* You will have a physical exam.\n* Blood (about 1-2 tablespoons) will be drawn for routine tests.\n\nOn Days 21 and 28 of Cycle 1 (+/- 3 days), you will have a bone marrow aspiration performed to check the status of the disease. You will then have a bone marrow aspiration performed every 7-14 days for the rest of the study. If at any point the disease appears to go into remission, you will then have a bone marrow aspiration performed every 1-3 cycles.\n\nBefore Day 1 of Cycles 2 and beyond:\n\n* Your medical history will be recorded.\n* You will have a physical exam.\n* Blood (about 1-2 tablespoons) will be drawn for routine tests.\n\nPregnancy Testing:\n\nIf you are a woman who is able to become pregnant, you will have blood (about 1-2 tablespoons) or urine pregnancy tests 1 time a week for the first 4 weeks of the study, then every 4 weeks while on study, when you stop the study, and 4 weeks after you are off study.\n\nIf you are a woman who is able to become pregnant and your menstrual cycles are irregular, you will have blood (about 1-2 tablespoons) or urine pregnancy test 1 time a week for the first 4 weeks, then every 2 weeks while on study, when you stop the study, and 2 and 4 weeks after you are off study.\n\nLength of Study:\n\nYou may continue to receive azacitidine as long as the doctor thinks it is in your best interest. You may receive lenalidomide as part of this study for as long as you are benefitting. You will be taken off study if the disease gets worse or you experience intolerable side effects.\n\nThis is an investigational study. Both azacitidine and lenalidomide are FDA approved and commercially available for the treatment of MDS. Azacitidine is not FDA approved or commercially available for treatment of AML. The combination as used in this study is investigational.\n\nUp to 88 participants will take part in this study. All will be enrolled at MD Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with higher risk MDS (bone marrow blasts \\>/= 10% to 30% inclusive) of any age who refuse or are not eligible for frontline chemotherapy.\n2. No prior therapy for higher risk MDS as defined above.\n3. Performance status of \\</= 2 by the Eastern Cooperative Oncology Group (ECOG) scale.\n4. Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of University of Texas MD Anderson Cancer Center (UTMDACC).\n5. Hydroxyurea for patients with rapidly proliferative disease can be used up to 24 hours prior to therapy but not concomitantly with 5-azacitidine or lenalidomide. Hydroxyurea can be used once the patient has completed the planned 5 azacitidine and lenalidomide treatment.\n6. Adequate liver function: Total bilirubin of \\</= 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) \\</= 3 x ULN\n7. Renal function - assessed by calculated creatinine clearance as follows (see Appendix: Cockcroft-Gault estimation of CrCl): 1. Phase I subjects must have calculated creatinine clearance \\>/= 60ml/min by Cockcroft-Gault formula. 2. Phase II subjects must have calculated creatinine clearance \\>/= 30ml/min by Cockcroft-Gault formula.\n8. All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of Revlimid REMS®.\n9. Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.\n10. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).\n11. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.\n12. Continued from #9: Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.\n\nExclusion Criteria:\n\n1. Nursing and pregnant females.\n2. Known or suspected hypersensitivity to azacitidine or mannitol.\n3. Patients with advanced malignant hepatic tumors.\n4. Unwilling or unable to remain in compliance with the RevAssist® program\n5. Known hypersensitivity to thalidomide or lenalidomide (if applicable).\n6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.\n7. Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.'}, 'identificationModule': {'nctId': 'NCT01038635', 'briefTitle': '5-Azacytidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Phase I/II Study of the Combination of 5-azacitidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)', 'orgStudyIdInfo': {'id': '2009-0467'}, 'secondaryIdInfos': [{'id': 'NCI-2011-01941', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5-Azacytidine + Lenalidomide', 'description': '5-Azacytidine 75 mg/m\\^2 by vein daily x 5 days on days 1 to 5. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.', 'interventionNames': ['Drug: 5-Azacytidine', 'Drug: Lenalidomide']}], 'interventions': [{'name': '5-Azacytidine', 'type': 'DRUG', 'otherNames': ['5-AZA', 'Azacitidine', 'Vidaza', '5-AZC', 'AZA-CR', 'Ladakamycin'], 'description': '75 mg/m\\^2 IV daily x 5 days on days 1 to 5.', 'armGroupLabels': ['5-Azacytidine + Lenalidomide']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'otherNames': ['CC-5013', 'Revlimid'], 'description': 'Starting dose 10 mg orally daily x 5 days on days 6 to 10.', 'armGroupLabels': ['5-Azacytidine + Lenalidomide']}]}, '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': 'Guillermo Garcia-Manero, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Celgene', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}