Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-29 @ 3:23 PM
Study NCT ID:
NCT01831232
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2013-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007947', 'term': 'Leukemia, Megakaryoblastic, Acute'}, {'id': 'D007948', 'term': 'Leukemia, Monocytic, Acute'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D015479', 'term': 'Leukemia, Myelomonocytic, Acute'}, {'id': 'D004915', 'term': 'Leukemia, Erythroblastic, Acute'}, {'id': 'D015477', 'term': 'Leukemia, Myelomonocytic, Chronic'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D000754', 'term': 'Anemia, Refractory, with Excess of Blasts'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000753', 'term': 'Anemia, Refractory'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017035', 'term': 'Pravastatin'}, {'id': 'D015255', 'term': 'Idarubicin'}, {'id': 'D003561', 'term': 'Cytarabine'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mshadman@fredhutch.org', 'phone': '206-667-5467', 'title': 'Dr, Mazyar Shadman', 'organization': 'Fred Hutchinson Cancer Research Ctr'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)', 'description': 'Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\npravastatin sodium: Given PO\n\nidarubicin: Given IV\n\ncytarabine: Given IV\n\nlaboratory biomarker analysis: Correlative studies', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 6, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Febrile neutropenia Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile neutropenia Grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand-foot syndrome Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic shock (Grade 4)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transaminitis Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Colon pneumatosis Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'GI bleeding Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tumor lysis syndrome Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Multi organ failure secondary to sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Good Complete Remission (CR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)', 'description': 'Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\npravastatin sodium: Given PO\n\nidarubicin: Given IV\n\ncytarabine: Given IV\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '35 days', 'description': 'A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.\n\nDefinition of Good CR: Conventional criteria for CR (absolute neutrophil count \\> 1,000/uL, platelet count \\> 100,000/uL, marrow with \\<5% morphologic blasts) and additionally the requirements that marrow Minimal Residual Disease (MRD) - detected by 10-color flow cytometry or conventional cytogenetic evaluation - be absent and that the above blood counts be obtained.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With TRM.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)', 'description': 'Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\npravastatin sodium: Given PO\n\nidarubicin: Given IV\n\ncytarabine: Given IV\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '27'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': 'A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.\n\nTRM: Treatment Related Mortality', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)', 'description': 'Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\npravastatin sodium: Given PO\n\nidarubicin: Given IV\n\ncytarabine: Given IV\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000', 'lowerLimit': '28.7', 'upperLimit': '71.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year after treatment with IAP', 'unitOfMeasure': 'percentage of patients with PFS', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had a good complete remission (CR), CR with evidence of minimal residual disease (MRD), or complete remission with incomplete blood count recovery (CRi) following treatment. Cheson AML Response Criteria are used to assess response.Good CR is defined as \\<5% blasts in marrow, no MRD and recovery of blood counts by day 35 after induction.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)', 'description': 'Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\npravastatin sodium: Given PO\n\nidarubicin: Given IV\n\ncytarabine: Given IV\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '71'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year after treatment with IAP', 'description': 'Amount of time a patient lives after treatment with IAP', 'unitOfMeasure': 'percentage of patients surviving', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Biomarker-positive Participants With Clinical Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)', 'description': 'Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\npravastatin sodium: Given PO\n\nidarubicin: Given IV\n\ncytarabine: Given IV\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '38 days after dosing', 'description': 'Biomarkers: FLT3-ITD positive, NPM1 positive, CEBPA. A "good CR" is defined as \\<5% blasts in the marrow by morphologic evaluation along with the absence of any MRD by flow cytometry or cytogenetics and recovery of blood counts (platelets \\>100,00 and absolute neutrophil count \\>1,000) by day 35 after induction. Cheson AML Response Criteria is used for Morphologic Leukemia Free State, Morphologic Complete Remission, Cytogenetic Complete Remission (CRc), Molecular Complete Remission (CRm), Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Partial Remission (PR), Treatment Failure, Recurrence (Progressive Disease).', 'unitOfMeasure': 'participants with clinical responses', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with biomarkers: FLT3-ITD positive, NPM1 positive or CEBPA'}, {'type': 'SECONDARY', 'title': 'Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)', 'description': 'Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\npravastatin sodium: Given PO\n\nidarubicin: Given IV\n\ncytarabine: Given IV\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'CRi', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '35 days', 'description': 'Complete remission (CR) - includes patients with good CR and CR with minimal residual disease (MRD); remission with incomplete blood count recovery (CRi), partial remission (PR)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patient who received IAP treatment were assessed for response. The number of participants with CR, CRi and PR are included in the table below.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)', 'description': 'Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\npravastatin sodium: Given PO\n\nidarubicin: Given IV\n\ncytarabine: Given IV\n\nlaboratory biomarker analysis: Correlative studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)', 'description': 'Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\npravastatin sodium: Given PO\n\nidarubicin: Given IV\n\ncytarabine: Given IV\n\nlaboratory biomarker analysis: Correlative studies'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '35', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'title': 'Acute Myeloid Leukemia (AML)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Myelodysplastic Syndrome (MDS)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Chronic Myelomonocytic Leukemia (CMML)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-16', 'studyFirstSubmitDate': '2013-04-08', 'resultsFirstSubmitDate': '2017-04-14', 'studyFirstSubmitQcDate': '2013-04-10', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-16', 'studyFirstPostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Good Complete Remission (CR)', 'timeFrame': '35 days', 'description': 'A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.\n\nDefinition of Good CR: Conventional criteria for CR (absolute neutrophil count \\> 1,000/uL, platelet count \\> 100,000/uL, marrow with \\<5% morphologic blasts) and additionally the requirements that marrow Minimal Residual Disease (MRD) - detected by 10-color flow cytometry or conventional cytogenetic evaluation - be absent and that the above blood counts be obtained.'}, {'measure': 'Number of Participants With TRM.', 'timeFrame': '28 days', 'description': 'A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.\n\nTRM: Treatment Related Mortality'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': '1 year after treatment with IAP'}, {'measure': 'Overall Survival', 'timeFrame': '1 year after treatment with IAP', 'description': 'Amount of time a patient lives after treatment with IAP'}, {'measure': 'Number of Biomarker-positive Participants With Clinical Responses', 'timeFrame': '38 days after dosing', 'description': 'Biomarkers: FLT3-ITD positive, NPM1 positive, CEBPA. A "good CR" is defined as \\<5% blasts in the marrow by morphologic evaluation along with the absence of any MRD by flow cytometry or cytogenetics and recovery of blood counts (platelets \\>100,00 and absolute neutrophil count \\>1,000) by day 35 after induction. Cheson AML Response Criteria is used for Morphologic Leukemia Free State, Morphologic Complete Remission, Cytogenetic Complete Remission (CRc), Molecular Complete Remission (CRm), Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Partial Remission (PR), Treatment Failure, Recurrence (Progressive Disease).'}, {'measure': 'Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR)', 'timeFrame': '35 days', 'description': 'Complete remission (CR) - includes patients with good CR and CR with minimal residual disease (MRD); remission with incomplete blood count recovery (CRi), partial remission (PR)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adult Acute Megakaryoblastic Leukemia (M7)', 'Adult Acute Minimally Differentiated Myeloid Leukemia (M0)', 'Adult Acute Monoblastic Leukemia (M5a)', 'Adult Acute Monocytic Leukemia (M5b)', 'Adult Acute Myeloblastic Leukemia With Maturation (M2)', 'Adult Acute Myeloblastic Leukemia Without Maturation (M1)', 'Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities', 'Adult Acute Myeloid Leukemia With Del(5q)', 'Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)', 'Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)', 'Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)', 'Adult Acute Myelomonocytic Leukemia (M4)', 'Adult Erythroleukemia (M6a)', 'Adult Pure Erythroid Leukemia (M6b)', 'Chronic Myelomonocytic Leukemia', 'de Novo Myelodysplastic Syndromes', 'Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable', 'Refractory Anemia With Excess Blasts', 'Untreated Adult Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'This clinical trial studies idarubicin, cytarabine, and pravastatin sodium in treating patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving idarubicin and cytarabine together with pravastatin sodium may kill more cancer cells.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess the rate of achieving a "good complete response (CR)" after treating patients with newly diagnosed acute myeloid leukemia (AML) with idarubicin, cytarabine and pravastatin (pravastatin sodium) (IAP).\n\nII. To determine the toxicity (death within 28 days of starting therapy = treatment related mortality or "TRM") with IAP in newly-diagnosed AML.\n\nSECONDARY OBJECTIVES:\n\nI. To determine rates of complete remission (CR), remission with incomplete blood count recovery (CRi), partial remission (PR), relapse-free survival and overall survival.\n\nII. To identify biomarkers (ie. changes in serum cholesterol) associated with clinical responses.\n\nOUTLINE:\n\nPatients receive pravastatin sodium orally (PO) once daily (QD) on days 1-8, idarubicin intravenously (IV) over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up every 3 months for 2 years and then annually for 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of acute myeloid leukemia by World Health Organization (WHO) 2008 criteria, including patients with \\>= 20% blasts in the bone marrow or peripheral blood (except acute promyelocytic leukemia), or myelodysplastic syndrome refractory anemia with excess blasts (RAEB)-2 by WHO classification or advanced myeloproliferative neoplasm with \\>= 10% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML) CMML-2 by WHO 2008 classification\n* Untreated AML or high-risk myelodysplastic syndrome (MDS) and a simplified TRM score of =\\< 9.2\n* Bilirubin \\< 2.0 mg/ml\n* Any creatinine value is acceptable\n* Any performance status is eligible\n* Life expectancy otherwise \\> 1 year\n* Patients are not excluded based on cardiac history\n* Females of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment\n* Patients must use an effective contraceptive method during the study and for a minimum of 90 days after study treatment\n* Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent'}, 'identificationModule': {'nctId': 'NCT01831232', 'briefTitle': 'Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Idarubicin, Cytarabine and Pravastatin (IAP) for Induction of Newly Diagnosed Acute Myeloid Leukemia (AML)', 'orgStudyIdInfo': {'id': '2674.00'}, 'secondaryIdInfos': [{'id': 'NCI-2013-00743', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2674.00', 'type': 'OTHER', 'domain': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium'}, {'id': 'P30CA015704', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015704', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (pravastatin sodium, idarubicin, and cytarabine)', 'description': 'Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: pravastatin sodium', 'Drug: idarubicin', 'Drug: cytarabine', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'pravastatin sodium', 'type': 'DRUG', 'otherNames': ['PRAV', 'Pravachol'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (pravastatin sodium, idarubicin, and cytarabine)']}, {'name': 'idarubicin', 'type': 'DRUG', 'otherNames': ['4-demethoxydaunorubicin', '4-DMDR', 'DMDR', 'IDA'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (pravastatin sodium, idarubicin, and cytarabine)']}, {'name': 'cytarabine', 'type': 'DRUG', 'otherNames': ['ARA-C', 'arabinofuranosylcytosine', 'arabinosylcytosine', 'Cytosar-U', 'cytosine arabinoside'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (pravastatin sodium, idarubicin, and cytarabine)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (pravastatin sodium, idarubicin, and cytarabine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Mazyar Shadman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mazyar Shadman', 'investigatorAffiliation': 'Fred Hutchinson Cancer Center'}}}}