Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 11:49 PM
Study NCT ID:
NCT00630994
Status:
TERMINATED
Last Update Posted:
2015-12-30
First Post:
2008-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low-Dose Decitabine in Treating Patients With Symptomatic 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': 'D013920', 'term': 'Thrombocythemia, Essential'}, {'id': 'D011087', 'term': 'Polycythemia Vera'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D013922', 'term': 'Thrombocytosis'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077209', 'term': 'Decitabine'}], 'ancestors': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mesa.ruben@mayo.edu', 'phone': '507-284-2511', 'title': 'Dr. Ruben A. Mesa', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study terminated early. Most analyses were not performed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Decitabine', 'description': '20 mg/m\\^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 17, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 16, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Bilirubin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 12, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}], 'seriousEvents': [{'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Clostridial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Achieve a Confirmed Response (Complete Remission (CR), Partial Remission (PR), or Clinical Improvement (CI)), According to International Working Group (IWG) Consensus Criteria.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Decitabine', 'description': '20 mg/m\\^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 4 weeks during treatment (up to 16 weeks)', 'description': 'Confirmed response: objective status of CR, PR, or CI on 2 consecutive evaluations \\>=4 weeks apart.\n\nCR:Complete resolution of disease-related symptoms and signs; peripheral blood count remission; normal leukocyte differential; bone marrow histologic remission.\n\nPR: All criteria for CR except the bone marrow histologic remission. CI: one of the following in the absence of both disease progression and CR/PR: minimum (MI) 20-g/L increase (INC) in hemoglobin level; MI 50% reduction in palpable splenomegaly (\\>=10cm); MI 100% INC in platelet count(\\>=50000x10\\^9/L) or ANC (\\>=0.5x10\\^9/L)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who met the eligibility criteria that have signed a consent form and went on treatment were evaluable for response. The study was terminated early due to slow enrollment. The primary outcome measure should be assessed with caution.'}, {'type': 'SECONDARY', 'title': 'Overall Survival(OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Decitabine', 'description': '20 mg/m\\^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle'}], 'timeFrame': 'up to 3 years', 'description': 'OS was defined as the time from registration to death of any cause.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated prematurely. Analysis not performed.'}, {'type': 'SECONDARY', 'title': 'Time to Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Decitabine', 'description': '20 mg/m\\^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle'}], 'timeFrame': 'up to 3 years', 'description': 'Time to disease progression is defined as the time from registration to progression of disease or death due to any cause.\n\nProgression was defined as any one or more of the following:\n\n1)progressive splenomegaly; 2) leukemic transformation confirmed by a bone marrow blast count of \\>= 20%; 3) an increase in peripheral blood blast percentage of \\>=20% that lasts for \\>= 8 weeks.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated prematurely. Analysis not performed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Constitutional Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Decitabine', 'description': '20 mg/m\\^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle'}], 'timeFrame': 'Up to 48 weeks', 'description': 'Constitutional symptoms including the presence of one or more of the following felt to be attributed to the disease: severe night sweats, fevers, weight loss and bone pain. Symptoms were assessed every cycle during treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated prematurely. Analysis not performed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Severe Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Decitabine', 'description': '20 mg/m\\^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle'}], 'classes': [{'title': 'Anemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophil count decreased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Leukopenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline Phosphatase Increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Ascites', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Clostridial Infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hyperglycemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 weeks', 'description': 'Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Adverse events were assessed every cycle during treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Decitabine', 'description': '20 mg/m\\^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Four (4) patient was recruited from March 2008 to May 2009 at Mayo Clinic. This trial was permanently closed in September 2009 due to slow accrual.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Decitabine', 'description': '20 mg/m\\^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'spread': '6.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior disease specific therapy (including drugs, stem cell transplant, or splenectomy)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior bleeding events felt to be related to underlying disease', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior thrombosis', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Category of Primary myelofibrosis', 'classes': [{'title': 'Primary Myelofibrosis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Post Essential Thrombocythemia (ET) Myelofibrosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Post Polycythemia Vera (PV) Myelofibrosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Stopped due to slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-25', 'studyFirstSubmitDate': '2008-03-06', 'resultsFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2008-03-06', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-05', 'studyFirstPostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Achieve a Confirmed Response (Complete Remission (CR), Partial Remission (PR), or Clinical Improvement (CI)), According to International Working Group (IWG) Consensus Criteria.', 'timeFrame': 'Every 4 weeks during treatment (up to 16 weeks)', 'description': 'Confirmed response: objective status of CR, PR, or CI on 2 consecutive evaluations \\>=4 weeks apart.\n\nCR:Complete resolution of disease-related symptoms and signs; peripheral blood count remission; normal leukocyte differential; bone marrow histologic remission.\n\nPR: All criteria for CR except the bone marrow histologic remission. CI: one of the following in the absence of both disease progression and CR/PR: minimum (MI) 20-g/L increase (INC) in hemoglobin level; MI 50% reduction in palpable splenomegaly (\\>=10cm); MI 100% INC in platelet count(\\>=50000x10\\^9/L) or ANC (\\>=0.5x10\\^9/L)'}], 'secondaryOutcomes': [{'measure': 'Overall Survival(OS)', 'timeFrame': 'up to 3 years', 'description': 'OS was defined as the time from registration to death of any cause.'}, {'measure': 'Time to Disease Progression', 'timeFrame': 'up to 3 years', 'description': 'Time to disease progression is defined as the time from registration to progression of disease or death due to any cause.\n\nProgression was defined as any one or more of the following:\n\n1)progressive splenomegaly; 2) leukemic transformation confirmed by a bone marrow blast count of \\>= 20%; 3) an increase in peripheral blood blast percentage of \\>=20% that lasts for \\>= 8 weeks.'}, {'measure': 'Number of Participants With Constitutional Symptoms', 'timeFrame': 'Up to 48 weeks', 'description': 'Constitutional symptoms including the presence of one or more of the following felt to be attributed to the disease: severe night sweats, fevers, weight loss and bone pain. Symptoms were assessed every cycle during treatment.'}, {'measure': 'Number of Participants With Severe Adverse Events', 'timeFrame': 'Up to 48 weeks', 'description': 'Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Adverse events were assessed every cycle during treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['primary myelofibrosis', 'secondary myelofibrosis', 'essential thrombocythemia', 'polycythemia vera'], 'conditions': ['Chronic Myeloproliferative Disorders', 'Secondary Myelofibrosis']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.\n\nPURPOSE: This phase II trial is studying the side effects and how well low-dose decitabine works in treating patients with symptomatic myelofibrosis.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the efficacy and safety of low-dose decitabine in patients with symptomatic primary myelofibrosis (PMF) or post essential thrombocythemic (ET) or polycythemic vera (PV) myelofibrosis.\n* Analyze the ability of this drug to decrease pathologic angiogenesis and other stromal reactive features intrinsic to PMF or post ET/PV myelofibrosis.\n\nOUTLINE: Patients receive low-dose decitabine IV over 1 hour on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving partial remission, complete remission, or clinical improvement may receive up to 12 courses of decitabine in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study therapy, patients are followed periodically for up to 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histological confirmation of primary myelofibrosis or post essential thrombocythemic or polycythemic vera myelofibrosis\n\n * Reticulin fibrosis ≥ grade 1\n* Evaluable and symptomatic disease worthy of treatment, characterized by ≥ 1 of the following:\n\n * Anemia, defined as hemoglobin \\< 11 g/dL or erythrocyte transfusion dependence\n * Palpable and symptomatic splenomegaly (palpable and symptomatic hepatomegaly is acceptable if previously splenectomized)\n * Severe, disease-related constitutional symptoms, including ≥ 1 of the following:\n\n * Severe night sweats\n * Fevers\n * Weight loss\n * Bone pain\n* Absence of t(9;22) by fluorescent in situ hybridization (FISH) or standard cytogenetics OR prior demonstration of a lack of this translocation\n\nPATIENT CHARACTERISTICS:\n\n* Eastern Co-operative Oncology Group (ECOG) performance status 0-3\n* Absolute neutrophil count (ANC) ≥ 1,000/mm³\n* Platelet count ≥ 50,000/mm³\n* Creatinine ≤ 2.0 mg/dL\n* Direct or total bilirubin ≤ 2.0 mg/dL\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times upper limit of normal (ULN) (≤ 5 times ULN if elevation is attributed to hepatic extramedullary hematopoiesis)\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Not incarcerated in a municipality, county, state, or federal prison\n* No serious medical condition or psychiatric illness that would preclude signing the informed consent\n* No condition that, in the opinion of the treating physician, places the patient at unacceptable risk for study participation or confounds the ability to interpret study data\n* Able to adhere to the study visit schedule and other study requirements\n\nPRIOR CONCURRENT THERAPY:\n\n* No other concurrent chemotherapy (e.g., hydroxyurea, thalidomide, interferon alpha, anagrelide, or other myelosuppressive agent) or experimental therapy'}, 'identificationModule': {'nctId': 'NCT00630994', 'briefTitle': 'Low-Dose Decitabine in Treating Patients With Symptomatic Myelofibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Phase II Trial of Low Dose Decitabine (Dacogen) in Patients With Primary Myelofibrosis and Post ET/PV Myelofibrosis', 'orgStudyIdInfo': {'id': 'CDR0000588839'}, 'secondaryIdInfos': [{'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}, {'id': 'MC0788', 'type': 'OTHER', 'domain': 'Mayo Clinic Cancer Center'}, {'id': 'NCI-2009-01330', 'type': 'REGISTRY', 'domain': 'NCI-CTRO'}, {'id': '07-005296', 'type': 'OTHER', 'domain': 'Mayo Clinic IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Dacogen', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'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': {'type': 'SPONSOR'}}}}