Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-03-02 @ 8:19 AM
Study NCT ID:
NCT01743859
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2012-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Azacitidine and Lenalidomide for Relapsed and Refractory Patients With Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, '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': 'daniel.pollyea@ucdenver.edu', 'title': 'Dr. Daniel Pollyea', 'organization': 'University of Colorado'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Azacitidine + Lenalidomide + Off Therapy', 'description': 'Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.', 'otherNumAtRisk': 37, 'otherNumAffected': 28, 'seriousNumAtRisk': 37, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clostridium Defficile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneuomonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Remission or Complete Remission With Incomplete Recovery Blood Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azacitidine + Lenalidomide + Off Therapy', 'description': 'Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Interim assessment after 18 patients (estimated 2 years) and full assessment after 37 patients (estimated 3-4 years)', 'description': 'Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Relapsed/refractory AML patients who received azacitidine and lenalidomide'}, {'type': 'PRIMARY', 'title': 'Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azacitidine + Lenalidomide + Off Therapy', 'description': 'Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Planned assessment after enrollment of all 37 patients (estimated 3-4 years)', 'description': 'Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'relapsed/refractory patients who received azacitidine and lenaldiomide'}, {'type': 'SECONDARY', 'title': 'Response or Remission Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azacitidine + Lenalidomide + Off Therapy', 'description': 'Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '308'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Depending on outcomes, will initiate this assessment after 2 years and will continue until completion of study, estimated at 4 years', 'description': 'Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Relapsed and refractory AML patients who received azacitidine and lenalidomide'}, {'type': 'SECONDARY', 'title': 'Toxicity and SAEs Related to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azacitidine + Lenalidomide + Off Therapy', 'description': 'Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Will begin assessment with first patient and will continue until completion of study, estimated to be 4 years', 'description': 'Change in baseline to end of study. To be measured based on Common Terminology Criteria for Adverse Events (CTCAE) criteria', 'unitOfMeasure': 'percentage of SAEs related to treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Relapsed and refractory AML patients who received azacitidine and lenalidomide -See toxicity data reported for results'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azacitidine + Lenalidomide + Off Therapy', 'description': 'Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.'}], 'classes': [{'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '355'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Depending on outcomes, will begin assessment at 2 years and will continue until completion of study, estimated to be at four years', 'description': 'Change in baseline to end of study', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Relapsed and refractory AML patients who received azacitidine and lenalidomide'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azacitidine + Lenalidomide + Off Therapy', 'description': 'Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '355'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Depending on outcomes, will initiate this assessment after 2 years and will continue until completion of study, estimated at 4 years', 'description': 'Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Relapsed and refractory AML patients who received azacitidine and lenalidomide'}, {'type': 'SECONDARY', 'title': 'Determine Biomarkers That Predict Response/Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azacitidine + Lenalidomide + Off Therapy', 'description': 'Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years after initiating study', 'description': 'Change in baseline to end of study. Planned assessments of methylation changes and other biomarkers. Computational biology modeling used to identify biomarkers and predict response.', 'unitOfMeasure': 'patients w/response predictor mutations', 'reportingStatus': 'POSTED', 'populationDescription': 'Relapsed and refractory AML patients who received azacitidine and lenalidomide.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Azacitidine + Lenalidomide + Off Therapy', 'description': 'Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Azacitidine + Lenalidomide + Off Therapy', 'description': 'Patients will receive 7 days of azacitidine followed by 3 weeks of lenalidomide. They will then have 2 weeks off therapy, for a maximum of 12 cycles.\n\nAzacitidine: Enrolled patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone.\n\nLenalidomide: Beginning on day 8, patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28.\n\nOff Therapy: 2 weeks off therapy, then begin sequence again for 12 weeks.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73', 'spread': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Relapsed and refractory AML patients who received azacitidine and lenalidomide'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2016-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-20', 'studyFirstSubmitDate': '2012-11-16', 'resultsFirstSubmitDate': '2019-07-05', 'studyFirstSubmitQcDate': '2012-12-04', 'lastUpdatePostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-20', 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Complete Remission or Complete Remission With Incomplete Recovery Blood Counts', 'timeFrame': 'Interim assessment after 18 patients (estimated 2 years) and full assessment after 37 patients (estimated 3-4 years)', 'description': 'Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR'}, {'measure': 'Overall Response Rate', 'timeFrame': 'Planned assessment after enrollment of all 37 patients (estimated 3-4 years)', 'description': 'Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination'}], 'secondaryOutcomes': [{'measure': 'Response or Remission Duration', 'timeFrame': 'Depending on outcomes, will initiate this assessment after 2 years and will continue until completion of study, estimated at 4 years', 'description': 'Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination'}, {'measure': 'Toxicity and SAEs Related to Treatment', 'timeFrame': 'Will begin assessment with first patient and will continue until completion of study, estimated to be 4 years', 'description': 'Change in baseline to end of study. To be measured based on Common Terminology Criteria for Adverse Events (CTCAE) criteria'}, {'measure': 'Overall Survival', 'timeFrame': 'Depending on outcomes, will begin assessment at 2 years and will continue until completion of study, estimated to be at four years', 'description': 'Change in baseline to end of study'}, {'measure': 'Progression-free Survival', 'timeFrame': 'Depending on outcomes, will initiate this assessment after 2 years and will continue until completion of study, estimated at 4 years', 'description': 'Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination'}, {'measure': 'Determine Biomarkers That Predict Response/Toxicity', 'timeFrame': 'Three years after initiating study', 'description': 'Change in baseline to end of study. Planned assessments of methylation changes and other biomarkers. Computational biology modeling used to identify biomarkers and predict response.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myeloid', 'Leukemia'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the complete remission/complete remission with incomplete recovery of blood counts (CR/CRi) rate for relapsed and refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) patients.', 'detailedDescription': 'AML patients with relapsed and refractory disease have very poor outcomes. Sequential azacitidine and lenalidomide was recently shown by the PI of this study to be well-tolerated and effective in elderly, treatment naïve AML patients. Observations from this study and others that have piloted this combination have suggested that patients who received and failed prior treatments may also respond to this regimen. Therefore, the sequential combination of azacitidine with lenalidomide could potentially improve outcomes for relapsed and refractory AML patients by providing them with a treatment option that is tolerable and potentially clinically synergistic. To determine the efficacy of this combination in this population, we will pilot this phase 2 study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • World Health Organization (WHO)-confirmed AML, other than Acute Promyelocytic Leukemia (APL)\n\n * Age \\>18 years\n * White blood cell count (WBC) at initiation of treatment ≤ 10,000/L\n\n o If WBC is \\> 10,000/L patients may be started on an appropriate dose of hydroxyurea (to be determined by the investigators), until WBC \\< 10,000/L, at which time the hydroxyurea will be discontinued for 12 hours prior to enrollment\n * Relapsed or refractory (resistant) disease, as defined by standard criteria21:\n\n * Relapsed: Bone marrow blasts ≥5%; reappearance of blasts in the blood; development of extramedullary disease\n * Refractory (resistant): Failure to achieve Complete Remission (CR) or complete remission with incomplete recovery of blood counts (CRi) in patients who survive ≥7 days following completion of initial treatment, with evidence of persistent leukemia by blood and/or bone marrow examination\n * Failure of at least one prior therapy\n * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (See Appendix D: ECOG Performance Status Scale)\n * Life expectancy \\> 2 months\n * All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist® (RevAssist is a restricted distribution program for receiving lenalidomide)\n * Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 million International Units per milliliter (mIU/mL) 10 - 14 days prior to study enrollment 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. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix F: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods\n * Willing and able to understand and voluntarily sign a written informed consent\n * Able to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n* • Known or suspected hypersensitivity to azacitidine or mannitol\n\n * Patients with advanced malignant hepatic tumors.\n * Treatment less than four weeks prior to enrollment with other experimental therapies or antineoplastic agents, with the exception of hydroxyurea\n * Inability to swallow or absorb drug\n * Prior treatment with lenalidomide for AML\n * Active opportunistic infection or treatment for opportunistic infection within four weeks of first day of study drug dosing\n * New York Heart Association Class III or IV heart failure\n * Unstable angina pectoris\n * Significant uncontrolled cardiac arrhythmias\n * Uncontrolled psychiatric illness that would limit compliance with requirements\n * Known Human immunodeficiency virus (HIV) infection\n * Graft vs. host disease ≥ grade 2\n * Relapse after allogeneic stem cell transplantation prior to post-transplant day 30\n * Pregnant or breast feeding females; lactating females must agree not to breast feed while taking lenalidomide\n * Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient's safety or interfere with data interpretation\n * Laboratory abnormalities:\n\n * Either creatinine \\>2.0 mg/dL or creatinine clearance \\<30 mL/min\n * Total bilirubin \\> 2 x institutional upper limit of normal (ULN) (unless documented Gilbert's syndrome)\n * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \\> 3 x institutional ULN"}, 'identificationModule': {'nctId': 'NCT01743859', 'briefTitle': 'Azacitidine and Lenalidomide for Relapsed and Refractory Patients With Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Sequential Treatment With Azacitidine and Lenalidomide for Relapsed and Refractory Patients With Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': '12-1283.cc'}, 'secondaryIdInfos': [{'id': 'NCI-2012-03191', 'type': 'OTHER', 'domain': 'National Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azacitidine + Lenalidomide + Off Therapy', 'description': 'Patients will receive 7 days of azacitidine followed by 3 weeks of lenalidomide. They will then have 2 weeks off therapy, for a maximum of 12 cycles.', 'interventionNames': ['Drug: Azacitidine', 'Drug: Lenalidomide', 'Other: Off Therapy']}], 'interventions': [{'name': 'Azacitidine', 'type': 'DRUG', 'otherNames': ['Vidaza (TM)'], 'description': 'Enrolled patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone.', 'armGroupLabels': ['Azacitidine + Lenalidomide + Off Therapy']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'otherNames': ['Revlimid (TM)'], 'description': 'Beginning on day 8, patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28.', 'armGroupLabels': ['Azacitidine + Lenalidomide + Off Therapy']}, {'name': 'Off Therapy', 'type': 'OTHER', 'description': '2 weeks off therapy, then begin sequence again for 12 weeks.', 'armGroupLabels': ['Azacitidine + Lenalidomide + Off Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Daniel Pollyea, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Celgene', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}