Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT00381693
Status:
TERMINATED
Last Update Posted:
2011-04-21
First Post:
2006-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Azacitidine in Treating Patients With Myelofibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D011087', 'term': 'Polycythemia Vera'}, {'id': 'D013920', 'term': 'Thrombocythemia, Essential'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D013922', 'term': 'Thrombocytosis'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001374', 'term': 'Azacitidine'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mesa.ruben@mayo.edu', 'phone': '507-284-3533', 'title': 'Dr. Ruben A. Mesa', 'phoneExt': '4-3533', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Azacitidine', 'description': 'Azacitidine 75 mg/m\\^2 subcutaneously', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Edema Limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 24, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 18, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 24, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patients With Confirmed Response (Complete Remission or Partial Remission on 2 Consecutive Evaluation at Least 4 Weeks Apart) During the First 4 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azacitidine', 'description': 'Azacitidine 75 mg/m\\^2 subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months', 'description': 'Response Definitions:\n\n* Completion Remission (CR):complete resolution of disease-related symptoms, ultrasound-documented resolution of hepastosplenomegaly, normalization of the peripheral blood count, white cell differential, and smear, normalization of bone marrow histology including disappearance of fibrosis and osteosclerosis. Residual cytogenetic abnormalities are allowed.\n* Partial Remission (PR): a major response in any baseline applicable criteria (except constitutional symptoms) without progression in any other category.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azacitidine', 'description': 'Azacitidine 75 mg/m\\^2 subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '21.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of registration until death or 3 years after registration if patient is still alive', 'description': 'OS was defined as the time from registration to death due to any cause or time from registration to 3 years after registration if patient is still alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azacitidine', 'description': 'Azacitidine 75 mg/m\\^2 subcutaneously'}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 3 years', 'description': 'Time to progression was defined as the time from registration to progression of disease. Those who die without documentation of disease progression will be considered to have had disease progression at the time of their death unless documented evidence clearly indicates no progression has occured.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 2 out of 10 patients had disease progression. One patient progressed at 0.5 months after registration and one patient progressed at 2.8 months after registration. Thus, median of time to progression and upper limit of 95% confidence interval are not attainable.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azacitidine', 'description': 'Azacitidine 75 mg/m\\^2 subcutaneously'}], 'classes': [{'title': 'Grade 1-2 Hematologic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3-4 Hematologic', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Grade 1-2 Non-hematologic', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3-4 Non-hematologic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 4 weeks during treatment', 'description': 'Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE.\n\nGrade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Azacitidine', 'description': 'Azacitidine 75 mg/m\\^2 subcutaneously'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Patient Choice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Ten patients were recruited from August 2006 to December 2007 at Mayo Clinic. This trial was permanently closed in December 2007 due to lack of accrual and it demonstrated too little clinical benefit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Azacitidine', 'description': 'Azacitidine 75 mg/m\\^2 subcutaneously'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000', 'lowerLimit': '57', 'upperLimit': '76'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease', 'classes': [{'title': 'Primary Myelofibrosis', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Post-polycythemia Vera Myelofibrosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Post-essential Thrombocythemia Myelofibrosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Lilie Score at Diagnosis (Myelofibrosis only)', 'classes': [{'title': '0 (Low Risk)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '1 (Intermediate Risk)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '2 (High Risk)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'A scoring system reported by Dupriez et al, which was constructed with the two adverse prognostic factors, namely Hb \\< 10 g/dL and WBC \\< 4 or \\> 30 x 10(9)/L, used to separate patients in three groups with low (0 factor), intermediate (1 factor), and high (2 factors) risks, associated with a median survival of 93, 26, and 13 months, respectively.', 'unitOfMeasure': 'participants'}, {'title': 'Red Cell Transfusion-dependent', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior Thrombosis or Hemorrhage', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior Therapy for Myelofibrosis', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Due to lack of accrual and trial has demonstrated too little clinical benefit', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-19', 'studyFirstSubmitDate': '2006-09-26', 'resultsFirstSubmitDate': '2010-11-09', 'studyFirstSubmitQcDate': '2006-09-26', 'lastUpdatePostDateStruct': {'date': '2011-04-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-22', 'studyFirstPostDateStruct': {'date': '2006-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients With Confirmed Response (Complete Remission or Partial Remission on 2 Consecutive Evaluation at Least 4 Weeks Apart) During the First 4 Months of Treatment', 'timeFrame': '4 months', 'description': 'Response Definitions:\n\n* Completion Remission (CR):complete resolution of disease-related symptoms, ultrasound-documented resolution of hepastosplenomegaly, normalization of the peripheral blood count, white cell differential, and smear, normalization of bone marrow histology including disappearance of fibrosis and osteosclerosis. Residual cytogenetic abnormalities are allowed.\n* Partial Remission (PR): a major response in any baseline applicable criteria (except constitutional symptoms) without progression in any other category.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From date of registration until death or 3 years after registration if patient is still alive', 'description': 'OS was defined as the time from registration to death due to any cause or time from registration to 3 years after registration if patient is still alive.'}, {'measure': 'Time to Progression', 'timeFrame': 'up to 3 years', 'description': 'Time to progression was defined as the time from registration to progression of disease. Those who die without documentation of disease progression will be considered to have had disease progression at the time of their death unless documented evidence clearly indicates no progression has occured.'}, {'measure': 'Number of Participants With Treatment Related Adverse Events', 'timeFrame': 'Every 4 weeks during treatment', 'description': 'Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE.\n\nGrade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['primary myelofibrosis', 'polycythemia vera', 'essential thrombocythemia', 'secondary myelofibrosis'], 'conditions': ['Chronic Myeloproliferative Disorders', 'Secondary Myelofibrosis']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing.\n\nPURPOSE: This phase II trial is studying how well azacitidine works in treating patients with myelofibrosis.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the efficacy of azacitidine in patients with myelofibrosis (MF) with myeloid metaplasia.\n* Evaluate the safety of azacitidine in these patients. Secondary\n* Evaluate pertinent biologic characteristics of MF before and during therapy with azacitidine.\n* Assess the effects of study treatment on constitutional symptoms in these patients.\n* Estimate time to event distributions for overall survival and progression. OUTLINE: Patients receive azacitidine subcutaneously once daily on days 1-5. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed periodically for up to 3 years.\n\nPROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed myelofibrosis with myeloid metaplasia (MMM), including any of the following subtypes:\n\n * Agnogenic myeloid metaplasia\n * Post-polycythemic myeloid metaplasia\n * Post-thrombocythemic myeloid metaplasia\n* Evaluable and symptomatic disease, defined as 1 of the following:\n\n * Anemia (hemoglobin \\< 10 g/dL or erythrocyte transfusion-dependent, requiring 1 transfusion ≤ 8 weeks)\n * Treatment required\\* for symptomatic palpable splenomegaly (palpable hepatomegaly is acceptable if previously splenectomized) NOTE: \\*Subjective but painful enough to mandate intervention\n* Absence of t(9;22) by fluorescent in situ hybridization (FISH) or standard cytogenetics (by peripheral blood or marrow)\n\n \\- Previous demonstration of a lack of this translocation (at any point) is sufficient\n* No advanced malignant hepatic tumors\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Absolute neutrophil count ≥ 1,000/mm³\n* Platelet count ≥ 50,000/mm³\n* Creatinine ≤ 2.0 mg/dL\n* Total bilirubin ≤ 2.0 mg/dL OR direct bilirubin ≤ 2.0 mg/dL if total bilirubin elevated (unless attributed to underlying disease)\n* AST and ALT ≤ 2 times upper limit of normal (unless clinically attributed to hepatic extramedullary hematopoiesis)\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No baseline peripheral or autonomic neuropathy ≥ grade 2\n* No condition, including the presence of laboratory abnormalities, that would preclude study compliance\n* No hypersensitivity to mannitol or azacitidine\n* Not incarcerated in a municipality (i.e., county, state, or federal prison)\n\nPRIOR CONCURRENT THERAPY:\n\n* At least 14 days since prior chemotherapy, including interferon alfa, anagrelide, or other myelosuppressive agents\n* At least 14 days since prior systemic corticosteroids\n* At least 14 days since prior investigational agents'}, 'identificationModule': {'nctId': 'NCT00381693', 'briefTitle': 'Azacitidine in Treating Patients With Myelofibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Phase II Study of Azacitidine in Myelofibrosis', 'orgStudyIdInfo': {'id': 'CDR0000503972'}, 'secondaryIdInfos': [{'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}, {'id': 'MC058D', 'type': 'OTHER', 'domain': 'Mayo Clinic Cancer Center'}, {'id': '05-004297', 'type': 'OTHER', 'domain': 'Mayo Clinic IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'azacitidine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Ruben A. Mesa, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Ruben A. Mesa', 'oldOrganization': 'Mayo Clinic Cancer Center'}}}}