Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-24 @ 8:55 PM
Study NCT ID:
NCT01407757
Status:
COMPLETED
Last Update Posted:
2016-05-19
First Post:
2011-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Gemtuzumab Ozogamicin Therapy in DNA Samples From Patients With Acute Myeloid Leukemia Treated on COG-AAML0531
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D015471', 'term': 'Leukemia, Basophilic, Acute'}, {'id': 'D015472', 'term': 'Leukemia, Eosinophilic, Acute'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015479', 'term': 'Leukemia, Myelomonocytic, Acute'}, {'id': 'D007948', 'term': 'Leukemia, Monocytic, Acute'}, {'id': 'D004915', 'term': 'Leukemia, Erythroblastic, Acute'}, {'id': 'D007947', 'term': 'Leukemia, Megakaryoblastic, Acute'}], 'ancestors': [{'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': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D000071185', 'term': 'Pharmacogenomic Testing'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2016-05-17', 'studyFirstSubmitDate': '2011-07-30', 'studyFirstSubmitQcDate': '2011-07-30', 'lastUpdatePostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genetic changes in CD33 impact outcome of gemtuzumab ozogamicin-based therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['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)', 'untreated adult acute myeloid leukemia', 'untreated childhood acute myeloid leukemia and other myeloid malignancies', 'adult acute basophilic leukemia', 'childhood acute basophilic leukemia', 'adult acute eosinophilic leukemia', 'childhood acute eosinophilic leukemia', 'adult acute myeloblastic leukemia without maturation (M1)', 'childhood acute myeloblastic leukemia without maturation (M1)', 'adult acute minimally differentiated myeloid leukemia (M0)', 'childhood acute minimally differentiated myeloid leukemia (M0)', 'adult acute myeloblastic leukemia with maturation (M2)', 'childhood acute myeloblastic leukemia with maturation (M2)', 'adult acute myelomonocytic leukemia (M4)', 'childhood acute myelomonocytic leukemia (M4)', 'adult acute monoblastic leukemia (M5a)', 'adult acute monocytic leukemia (M5b)', 'childhood acute monoblastic leukemia (M5a)', 'childhood acute monocytic leukemia (M5b)', 'adult erythroleukemia (M6a)', 'adult pure erythroid leukemia (M6b)', 'childhood acute erythroleukemia (M6)', 'adult acute megakaryoblastic leukemia (M7)', 'childhood acute megakaryocytic leukemia (M7)', 'recurrent adult acute myeloid leukemia', 'recurrent childhood acute myeloid leukemia'], 'conditions': ['Leukemia']}, 'referencesModule': {'references': [{'pmid': '34048275', 'type': 'DERIVED', 'citation': "Pollard JA, Guest E, Alonzo TA, Gerbing RB, Loken MR, Brodersen LE, Kolb EA, Aplenc R, Meshinchi S, Raimondi SC, Hirsch B, Gamis AS. Gemtuzumab Ozogamicin Improves Event-Free Survival and Reduces Relapse in Pediatric KMT2A-Rearranged AML: Results From the Phase III Children's Oncology Group Trial AAML0531. J Clin Oncol. 2021 Oct 1;39(28):3149-3160. doi: 10.1200/JCO.20.03048. Epub 2021 May 28."}, {'pmid': '31182436', 'type': 'DERIVED', 'citation': 'Tarlock K, Alonzo TA, Wang YC, Gerbing RB, Ries R, Loken MR, Pardo L, Hylkema T, Joaquin J, Sarukkai L, Raimondi SC, Hirsch B, Sung L, Aplenc R, Bernstein I, Gamis AS, Meshinchi S, Pollard JA. Functional Properties of KIT Mutations Are Associated with Differential Clinical Outcomes and Response to Targeted Therapeutics in CBF Acute Myeloid Leukemia. Clin Cancer Res. 2019 Aug 15;25(16):5038-5048. doi: 10.1158/1078-0432.CCR-18-1897. Epub 2019 Jun 10.'}, {'pmid': '28411282', 'type': 'DERIVED', 'citation': "Vujkovic M, Attiyeh EF, Ries RE, Goodman EK, Ding Y, Kavcic M, Alonzo TA, Wang YC, Gerbing RB, Sung L, Hirsch B, Raimondi S, Gamis AS, Meshinchi S, Aplenc R. Genomic architecture and treatment outcome in pediatric acute myeloid leukemia: a Children's Oncology Group report. Blood. 2017 Jun 8;129(23):3051-3058. doi: 10.1182/blood-2017-03-772384. Epub 2017 Apr 14."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: DNA analysis of blood and tissue samples may help doctors predict how well patients will respond to treatment. It may also help doctors learn more about how gemtuzumab ozogamicin works in the body.\n\nPURPOSE: This research study is looking at gemtuzumab ozogamicin in DNA samples from patients with acute myeloid leukemia treated on COG-AAML0531.', 'detailedDescription': 'OBJECTIVES:\n\n* To genotype the genomic DNA from acute myeloid leukemia (AML) patients treated on COG-AAML0531 clinical trial for CD33 (and PgP and SOC3) single nucleotide polymorphisms (SNPs).\n\nOUTLINE: Archived DNA samples are analyzed for single nucleotide polymorphisms in CD33, PgP, and SOC3 genes by Sequenome platform. Results are then compared with patients clinical outcomes, including minimal-residual disease levels post induction I (chemotherapy and gemtuzumab ozogamicin), complete remission rates, refractory disease with various levels of bone marrow blasts, development of CNS/persistent disease, event-free survival, overall survival, and toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '29 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosed with acute myeloid leukemia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosed with acute myeloid leukemia\n* DNA samples from patients treated on COG-AAML0531\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT01407757', 'briefTitle': 'Study of Gemtuzumab Ozogamicin Therapy in DNA Samples From Patients With Acute Myeloid Leukemia Treated on COG-AAML0531', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Pharmacogenetics of Gemtuzumab Ozogamicin (GO) Therapy in Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'AAML11B10'}, 'secondaryIdInfos': [{'id': 'COG-AAML11B10', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'AAML11B10', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'NCI-2011-03802', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'DNA analysis', 'type': 'GENETIC'}, {'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'pharmacogenomic studies', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jatinder Lamba, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masonic Cancer Center, University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}