Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT01150656
Status:
COMPLETED
Last Update Posted:
2016-05-18
First Post:
2010-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Obatoclax Mesylate in Samples From Young Patients With Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D046228', 'term': 'Microarray Analysis'}, {'id': 'D020133', 'term': 'Reverse Transcriptase Polymerase Chain Reaction'}, {'id': 'D015153', 'term': 'Blotting, Western'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D046208', 'term': 'Microchip Analytical Procedures'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D004586', 'term': 'Electrophoresis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}, {'id': 'D015151', 'term': 'Immunoblotting'}, {'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2016-05-17', 'studyFirstSubmitDate': '2010-06-24', 'studyFirstSubmitQcDate': '2010-06-24', 'lastUpdatePostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Obatoclax mesylate activity'}, {'measure': 'Optimum in vitro combinations of obatoclax mesylate'}, {'measure': 'Pharmacodynamic (PD) biomarkers of activity'}, {'measure': 'Cell death mechanism in multiple-lineage leukemia (MLL) acute myeloid leukemia (AML)'}, {'measure': 'Disease progression in a xenograft model of MLL-rearranged infant AML'}], 'secondaryOutcomes': [{'measure': 'Physical assessment (in xenograft model)'}, {'measure': 'Peripheral blast count reduction'}, {'measure': 'Apoptosis and/or ATG induction'}, {'measure': 'Modulation of relevant PD biomarkers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['childhood acute myeloid leukemia/other myeloid malignancies'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying the effects of obatoclax mesylate in cell samples from patients with cancer in the laboratory may help doctors learn more about the effects of obatoclax mesylate on cancer cells. It may also help doctors identify biomarkers related to cancer.\n\nPURPOSE: This research study is studying obatoclax mesylate in samples from young patients with acute myeloid leukemia.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine comprehensive gene and protein expression profiles of in vitro sensitivity and resistance to obatoclax mesylate in multiple-lineage leukemia (MLL)-rearranged cell lines and primary infant acute myeloid leukemia (AML) samples.\n* Define optimum in vitro combinations of obatoclax mesylate targeting pro-survival BCL-2 family proteins with cytotoxic drugs in MLL-rearranged leukemia cell lines and primary infant AML samples.\n* Identify synergistic combinations based on a pharmacodynamic modeling and simulation construct.\n* Determine whether combinations of obatoclax mesylate targeting pro-survival BCL-2 family proteins with cytotoxic drugs improves survival in a xenograft model of MLL-rearranged infant AML.\n\nOUTLINE: This is a multicenter study.\n\nObatoclax mesylate activity is assessed via the MTT assay. A priori features of acute myeloid leukemia (AML) blasts relating to the apoptosis and ATG cell death pathways and their execution are characterized using microarray analysis and quantitative real-time (Q-RT) PCR. Gene and protein expression is described and quantified using Q-RT PCR and western blot analysis at specific time points after obatoclax mesylate exposure to identify pharmacodynamic biomarkers of activity and characterize the cell death mechanism in multiple-lineage leukemia (MLL)+ AML. The MTT assay is performed using obatoclax mesylate-cytotoxic chemotherapy combinations to determine synergy focusing on common cytotoxic drugs employed in AML treatment regimens.\n\nObatoclax mesylate efficacy is tested in a therapeutic NOG xenograft model of primary MLL+ infant AML.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients With Acute Myeloid Leukemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of acute myeloid leukemia (AML)\n* Cryopreserved samples from infants with AML available\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT01150656', 'briefTitle': 'Obatoclax Mesylate in Samples From Young Patients With Acute Myeloid Leukemia', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'SCOR in Targeted Therapies for Infant Leukemias Project 2: Targeting Apoptosis in Leukemia in Infants', 'orgStudyIdInfo': {'id': 'AAML10B17'}, 'secondaryIdInfos': [{'id': 'COG-AAML10B17', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'NCI-2011-02239', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'AAML10B17', 'type': 'OTHER', 'domain': "Children's Oncology Group"}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'microarray analysis', 'type': 'GENETIC'}, {'name': 'protein expression analysis', 'type': 'GENETIC'}, {'name': 'reverse transcriptase-polymerase chain reaction', 'type': 'GENETIC'}, {'name': 'western blotting', 'type': 'GENETIC'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'pharmacological study', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Carolyn A. Felix, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}