Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT00795002
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2008-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
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'}], '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': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C077990', 'term': 'alvocidib'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D003561', 'term': 'Cytarabine'}], 'ancestors': [{'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'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': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': 'jkarp2@jhmi.edu', 'phone': '410-502-7726', 'title': 'Judith Karp, MD', 'organization': 'The Sidney Kimmel Comprehensive Cancer Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 cycle of therapy', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I', 'description': 'Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.', 'otherNumAtRisk': 39, 'otherNumAffected': 1, 'seriousNumAtRisk': 39, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Arm II', 'description': 'Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.', 'otherNumAtRisk': 39, 'otherNumAffected': 1, 'seriousNumAtRisk': 39, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'General disorders-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Tumor Lysis Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral and/or Gastrointestinal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I', 'description': 'Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.'}, {'id': 'OG001', 'title': 'Arm II', 'description': 'Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Bone marrow showing less than 5% leukemic blasts with normal maturation of all cell lines, an ANC of at least 1000/uL and a platelet count of 100,000/uL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. Repeat marrow confirmation 4-6 weeks following the marrow documenting CR is not required due to the need for continued treatment in CR.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Death From Any Cause Within 60 Days of Starting FLAM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I', 'description': 'Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.'}, {'id': 'OG001', 'title': 'Arm II', 'description': 'Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days', 'description': 'Toxicity defined as death from any cause within 60 days of starting FLAM.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy. Toxicity defined as death from any cause within 60 days of starting FLAM.'}, {'type': 'SECONDARY', 'title': 'Disease-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I', 'description': 'Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.'}, {'id': 'OG001', 'title': 'Arm II', 'description': 'Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'comment': 'The 95% confidence interval is reported as 10.1 to infinity (10.1-inf)', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': 'NA'}, {'value': '12.0', 'comment': 'The 95% confidence interval is reported as 9.2 to infinity (9.2-inf)', 'groupId': 'OG001', 'lowerLimit': '9.2', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 2 years', 'description': 'This will be defined as the time between study entry and the first date that recurrent or progressive disease is objectively documented, or death from any cause occurs.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I', 'description': 'Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.'}, {'id': 'FG001', 'title': 'Arm II', 'description': 'Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All newly diagnosed adults diagnosed with AML were considered for participation.Enrolled on study between November 20, 2008 and July 20, 2010.', 'preAssignmentDetails': '2 patients on each arm consented to study, but were screen failures and did not start treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I', 'description': 'Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.'}, {'id': 'BG001', 'title': 'Arm II', 'description': 'Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'spread': '54', 'groupId': 'BG000'}, {'value': '59', 'spread': '53', 'groupId': 'BG001'}, {'value': '60', 'spread': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-03', 'studyFirstSubmitDate': '2008-11-20', 'resultsFirstSubmitDate': '2013-01-08', 'studyFirstSubmitQcDate': '2008-11-20', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-10-07', 'studyFirstPostDateStruct': {'date': '2008-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Response', 'timeFrame': '1 year', 'description': 'Bone marrow showing less than 5% leukemic blasts with normal maturation of all cell lines, an ANC of at least 1000/uL and a platelet count of 100,000/uL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. Repeat marrow confirmation 4-6 weeks following the marrow documenting CR is not required due to the need for continued treatment in CR.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Experiencing Death From Any Cause Within 60 Days of Starting FLAM', 'timeFrame': '60 days', 'description': 'Toxicity defined as death from any cause within 60 days of starting FLAM.'}, {'measure': 'Disease-free Survival', 'timeFrame': 'up to 2 years', 'description': 'This will be defined as the time between study entry and the first date that recurrent or progressive disease is objectively documented, or death from any cause occurs.'}]}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome', '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)', 'Secondary Acute Myeloid Leukemia', 'Untreated Adult Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'This randomized phase II trial is studying two different schedules of alvocidib to compare how well they work when given together with cytarabine and mitoxantrone in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as alvocidib, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known which schedule of alvocidib is more effective when given together with cytarabine and mitoxantrone in treating patients with acute myeloid leukemia.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To compare the efficacy of two different schedules (bolus vs "hybrid bolus-infusion") of alvocidib followed by cytarabine and mitoxantrone hydrochloride in patients with newly diagnosed acute myeloid leukemia (AML) with poor-risk features.\n\nSECONDARY OBJECTIVES:\n\nI. To compare the toxicities of these regimens. II. To determine the disease-free survival and overall survival of patients who demonstrate a response to these regimens.\n\nIII. To compare the pharmacokinetics of alvocidib when administered in two different schedules (bolus vs "hybrid bolus-infusion").\n\nIV. To describe alvocidib-induced alterations in AML blast cell expression of selected target mRNA and proteins.\n\nV. To describe alvocidib-induced alterations in AML blast cell growth kinetic parameters.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to antecedent hematologic disorder of \\>= 6 months duration prior to transformation to acute myeloid leukemia (AML) and any prior antecedent therapy for myelodysplastic syndromes or myeloproliferative disorder. Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.\n\nARM II: Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.\n\nPatients achieving partial or complete response (CR) after the first course of treatment may receive a second course of treatment 35-63 days following blood count recovery and/or undergo allogeneic bone marrow transplantation. Patients \\>= 50 years of age with t (8;21), inv (16), or t(16;16) AML who achieve CR after the first course of treatment may receive 3-4 courses of high-dose cytarabine consolidation therapy.\n\nBone marrow and/or blood samples are collected at baseline and periodically during study for correlative laboratory studies, including pharmacokinetic studies by liquid chromatography and tandem mass spectrometry, analysis of blast cell growth kinetic parameters by flow cytometry, and blast cell expression of selected target mRNA and protein by quantitative RT-PCR and western blotting.\n\nAfter completion of study therapy, patients are followed periodically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed newly diagnosed acute myeloid leukemia (AML) meeting the following criteria:\n\n * Subtypes M0, M1, M2, M4-7\n * No acute promyelocytic leukemia (M3)\n* At least 50 years of age OR \\>= 18 years of age with \\>= 1 of the following poor-risk disease features:\n\n * Antecedent hematologic disorder, including myelodysplastic syndromes (MDS)-related AML or prior myeloproliferative disorder (MPD)\n * Treatment-related AML, AML with trilineage dysplasia\n * Myeloid sarcoma, myeloid proliferations related to Down Syndrome, or blastic plasmacytoid dendritic cell neoplasm\n * AML with trilineage dysplasia\n* AML with adverse cytogenetics (defined as -5/-5q; -7/-7q; abnormal 3q, 9q, 11q, 20q, 21q, or 17p; t\\[6;9\\]; t\\[9;22\\]; trisomy 8; trisomy 13, complex karyotypes \\[\\>= 3 unrelated abnormalities\\]),\n* No hyperleukocytosis with \\>= 50,000 blasts/uL (leukapheresis or hydroxyurea allowed for cytoreduction immediately prior to the first dose of alvocidib)\n* No active CNS leukemia\n* ECOG performance status 0-2\n* Serum creatinine =\\< 2.0 mg/dL\n* ALT/AST =\\< 5 times upper limit of normal\n* Bilirubin =\\< 2.0 mg/dL\n* Not pregnant or nursing\n* Negative pregnancy test\n* No active uncontrolled infection\n* Infection that is under active treatment allowed provided it is controlled with antibiotics\n* No other life-threatening illness\n* No mental deficits and/or psychiatric history that would preclude giving informed consent or following study requirements\n* At least 24 hours since prior leukapheresis or hydroxyurea for cytoreduction\n* Prior non-cytotoxic therapies (e.g., thalidomide or lenalidomide, interferon, cytokines, low-dose 5-azacytidine, or low-dose cytoxan) for MDS or MPD allowed\n* Prior chemotherapy or bone marrow/stem cell transplantation for non-AML malignancy allowed\n* No prior alvocidib\n* No other concurrent chemotherapy, radiotherapy, or immunotherapy\n* No other concurrent investigational or commercially-available antitumor therapies for AML\n* LVEF \\>= 45%'}, 'identificationModule': {'nctId': 'NCT00795002', 'briefTitle': 'Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Randomized Phase II Study Comparing Two Administration Schedules of Flavopiridol (Alvocidib, NSC 649890, IND 46, 211) Given in Timed Sequential Combination With Cytosine Arabinoside (Ara-C) and Mitoxantrone Hydrochloride for Adults With Newly Diagnosed, Previously Untreated, Poor Risk Acute Myelogenous Leukemias (AML)', 'orgStudyIdInfo': {'id': 'NCI-2009-00298'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00298', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000625222'}, {'id': 'J0856', 'type': 'OTHER', 'domain': 'Johns Hopkins University/Sidney Kimmel Cancer Center'}, {'id': '8237', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'P30CA006973', 'link': 'https://reporter.nih.gov/quickSearch/P30CA006973', 'type': 'NIH'}, {'id': 'U01CA070095', 'link': 'https://reporter.nih.gov/quickSearch/U01CA070095', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.', 'interventionNames': ['Drug: alvocidib', 'Drug: mitoxantrone hydrochloride', 'Drug: cytarabine', 'Other: pharmacological study', 'Other: laboratory biomarker analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II', 'description': 'Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.', 'interventionNames': ['Drug: alvocidib', 'Drug: mitoxantrone hydrochloride', 'Drug: cytarabine', 'Other: pharmacological study', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'alvocidib', 'type': 'DRUG', 'otherNames': ['FLAVO', 'flavopiridol', 'HMR 1275', 'L-868275'], 'description': 'Given IV', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'mitoxantrone hydrochloride', 'type': 'DRUG', 'otherNames': ['CL 232315', 'DHAD', 'DHAQ', 'Novantrone'], 'description': 'Given IV', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'cytarabine', 'type': 'DRUG', 'otherNames': ['ARA-C', 'arabinofuranosylcytosine', 'arabinosylcytosine', 'Cytosar-U', 'cytosine arabinoside'], 'description': 'Given IV', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'pharmacological study', 'type': 'OTHER', 'otherNames': ['pharmacological studies'], 'description': 'Correlative studies', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I', 'Arm II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University/Sidney Kimmel Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'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': 'Judith Karp', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University/Sidney Kimmel Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}