Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-01 @ 7:24 AM
Study NCT ID:
NCT03226418
Status:
COMPLETED
Last Update Posted:
2025-11-05
First Post:
2017-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D000077209', 'term': 'Decitabine'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D015255', 'term': 'Idarubicin'}, {'id': 'C000629812', 'term': 'CPX-351'}, {'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'C579720', 'term': 'venetoclax'}, {'id': 'C000592580', 'term': 'glasdegib'}], 'ancestors': [{'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'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'IITOffice@unmc.edu', 'phone': '402-559-5520', 'title': 'Vijaya Bhatt', 'organization': 'University of Nebraska Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Ongoing from initiation of study drug until 30 days after last administration of study drug, up to 20 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Group I', 'description': 'INTENSIVE INDUCTION THERAPY: Patients receive cytarabine intravenously (IV) on days 1-7 and idarubicin over 10-15 minutes on days 1-3 (7+3), or liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3 and 5. Gemtuzumab or midostaurin are added to 7+3 as per the standard of care. Treatment continues for 1 course in the absence of unacceptable toxicity.\n\nINTENSIVE CONSOLIDATION THERAPY: Patients who go into remission, receive cytarabine IV over 1-3 hours twice daily (BID) on days 1, 3, and 5. Treatment repeats every 4 weeks for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients treated with liposome-encapsulated daunorubicin-cytarabine receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 5-8 weeks for 2 courses in the absence of disease progression, unacceptable toxicity.\n\nCytarabine: Given IV\n\nIdarubicin: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLiposome-encapsulated Daunorubicin-Cytarabine: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Group II', 'description': 'LOW-INTENSITY: Patients receive venetoclax in combination with azacitidine or decitabine or other standard of care low-intensity therapy such as azacitidine or decitabine alone or in combination with FLT3 inhibitor such as midostaurin, low-dose cytarabine in combination with glasdegib.\n\nVenetoclax dose varies depending on drug interaction with antifungal agents. Given daily continuous for \\>= 3 months orally. Glasdegib dose is 100 mg oral daily.\n\nDecitabine IV over 1-3 hours daily for 5-10 days. Treatment repeats every 4-5 weeks for \\>= 3 courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant. Azacitidine IV infusion over 10 to 40 minutes days 1 -7. Treatment repeats every 4-5 weeks for \\>= 3 courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant.\n\nDecitabine: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nAzacitidine: Given by infusion\n\nVenetoclax: oral tablet\n\nglasdegib: oral tablet', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 65, 'seriousNumAtRisk': 65, 'deathsNumAffected': 15, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 65, 'numAffected': 65}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 65, 'numAffected': 65}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 65, 'numAffected': 65}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 63, 'numAffected': 63}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gallbladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Catheter-related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tumor lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal/Urinary disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Complete Remission and Mortality in the Entire Cohort of Older Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Cohort', 'description': 'Includes entire study cohort of older adults.'}], 'classes': [{'title': '90-Day Mortality', 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}]}]}, {'title': 'Remission', 'categories': [{'measurements': [{'value': '52.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 90 days', 'description': 'All analyses will be performed based on intent-to-treat principle. The method of inversion will be used to generate an interval estimate for the proportion of 90-day mortality.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': '"It was pre-specified to report for the entire cohort as a whole in this Outcome Measure. Results for each Arm/Group are pre-specified to be reported separately in Outcome Measure 2,"'}, {'type': 'SECONDARY', 'title': 'Rate of Complete Remission and Mortality in Subsets of Older Patients Who Receive Intensive and Low-intensity Chemotherapy', 'timeFrame': 'At 90 days', 'description': 'All analyses will be performed based on intent-to-treat principle. The method of inversion will be used to generate an interval estimate for the proportion of 90-day mortality.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-10'}, {'type': 'SECONDARY', 'title': 'Baseline Functional Status Measure by Geriatric Assessment', 'timeFrame': 'At 90 days', 'description': 'Will assess the impact of baseline functional status on the rate of complete remission and mortality.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-10'}, {'type': 'SECONDARY', 'title': 'Baseline Functional Status', 'timeFrame': 'Up to 90 days', 'description': 'Will evaluate the influence of baseline functional status on the quality of life and neurocognitive status. The association between categories of functional status and quality of life will be explored using analysis of variance (ANOVA); if assumptions of ANOVA fail, Kruskal Wallis will be used. The association between functional status (fit or vulnerable) and neurocognitive status (\\< 25 or 26 or higher) will be explored using a chi-square test. A generalized linear mixed model will be utilized to evaluate changes in quality of life over time. The proportion (and associated 95% confidence interval) of patients with definitely or probably modifiable impairments will be presented.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-10'}, {'type': 'SECONDARY', 'title': 'Symptom Burden', 'timeFrame': 'Baseline (diagnosis), 10, 30 and 90 days following initiation of chemotherapy', 'description': 'Symptom burden will be determined using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30) at four time points. This instrument asks 28 questions about symptoms and their effects which are scored 1 to 4. Higher scores indicate worse symptoms and effects. Two additional questions ask about overall health and quality of life during the past week and are scored 1 to 7. Higher scores indicate better weekly health and quality of life.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-10'}, {'type': 'SECONDARY', 'title': 'Mortality at 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I', 'description': 'INTENSIVE INDUCTION THERAPY: Patients receive cytarabine intravenously (IV) on days 1-7 and idarubicin over 10-15 minutes on days 1-3 (7+3), or liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3 and 5. Gemtuzumab or midostaurin are added to 7+3 as per the standard of care. Treatment continues for 1 course in the absence of unacceptable toxicity.\n\nINTENSIVE CONSOLIDATION THERAPY: Patients who go into remission, receive cytarabine IV over 1-3 hours twice daily (BID) on days 1, 3, and 5. Treatment repeats every 4 weeks for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients treated with liposome-encapsulated daunorubicin-cytarabine receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 5-8 weeks for 2 courses in the absence of disease progression, unacceptable toxicity.\n\nCytarabine: Given IV\n\nIdarubicin: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLiposome-encapsulated Daunorubicin-Cytarabine: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG001', 'title': 'Group II', 'description': 'LOW-INTENSITY: Patients receive venetoclax in combination with azacitidine or decitabine or other standard of care low-intensity therapy such as azacitidine or decitabine alone or in combination with FLT3 inhibitor such as midostaurin, low-dose cytarabine in combination with glasdegib.\n\nVenetoclax dose varies depending on drug interaction with antifungal agents. Given daily continuous for \\>= 3 months orally. Glasdegib dose is 100 mg oral daily.\n\nDecitabine IV over 1-3 hours daily for 5-10 days. Treatment repeats every 4-5 weeks for \\>= 3 courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant. Azacitidine IV infusion over 10 to 40 minutes days 1 -7. Treatment repeats every 4-5 weeks for \\>= 3 courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant.\n\nDecitabine: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nAzacitidine: Given by infusion\n\nVenetoclax: oral tablet\n\nglasdegib: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 90 days from diagnosis', 'description': 'Mortality at 90 days will be calculated from date of diagnosis to date of death due to any cause within 90 days from diagnosis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire', 'timeFrame': 'Several time points after completion of treatment, up to 2 years', 'description': 'The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), Version 3.0, will be given at several time points in follow-up after completion of treatment. The instrument assesses cancer patients\' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items.\n\nA linear transformation is used to standardise the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. The scores will be utilized to determine quality of life status will be used to evaluate changes in quality of life over time.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-10'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Status as Measured by the Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'Several time points after completion of treatment, up to 2 years', 'description': 'The Montreal Cognitive Assessment (MoCA) will be given at several time points in follow-up after completion of treatment. The instrument assesses different cognitive domains, including attention, visuospatial skills, executive functions, memory, language, and abstract thinking. Each task has a specific scoring guide, with points awarded based on performance. Composite scores of 26-30 generally indicates normal cognitive function, 18-25 suggests mild cognitive impairment, 10-17 indicates moderate impairment, and scores below 10 point to severe cognitive impairment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-10'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group I', 'description': 'INTENSIVE INDUCTION THERAPY: Patients receive cytarabine intravenously (IV) on days 1-7 and idarubicin over 10-15 minutes on days 1-3 (7+3), or liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3 and 5. Gemtuzumab or midostaurin are added to 7+3 as per the standard of care. Treatment continues for 1 course in the absence of unacceptable toxicity.\n\nINTENSIVE CONSOLIDATION THERAPY: Patients who go into remission, receive cytarabine IV over 1-3 hours twice daily (BID) on days 1, 3, and 5. Treatment repeats every 4 weeks for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients treated with liposome-encapsulated daunorubicin-cytarabine receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 5-8 weeks for 2 courses in the absence of disease progression, unacceptable toxicity.\n\nCytarabine: Given IV\n\nIdarubicin: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLiposome-encapsulated Daunorubicin-Cytarabine: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'FG001', 'title': 'Group II', 'description': 'LOW-INTENSITY: Patients receive venetoclax in combination with azacitidine or decitabine or other standard of care low-intensity therapy such as azacitidine or decitabine alone or in combination with fms-like tyrosine kinase 3 (FLT3) inhibitor such as midostaurin, low-dose cytarabine in combination with glasdegib.\n\nVenetoclax dose varies depending on drug interaction with antifungal agents. Given daily continuous for \\>= 3 months orally. Glasdegib dose is 100 mg oral daily.\n\nDecitabine IV over 1-3 hours daily for 5-10 days. Treatment repeats every 4-5 weeks for \\>= 3 courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant. Azacitidine IV infusion over 10 to 40 minutes days 1 -7. Treatment repeats every 4-5 weeks for \\>= 3 courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant.\n\nDecitabine: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nAzacitidine: Given by infusion\n\nVenetoclax: oral tablet\n\nglasdegib: oral tablet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '2 participants ineligible'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group I', 'description': 'INTENSIVE INDUCTION THERAPY: Patients receive cytarabine intravenously (IV) on days 1-7 and idarubicin over 10-15 minutes on days 1-3 (7+3), or liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3 and 5. Gemtuzumab or midostaurin are added to 7+3 as per the standard of care. Treatment continues for 1 course in the absence of unacceptable toxicity.\n\nINTENSIVE CONSOLIDATION THERAPY: Patients who go into remission, receive cytarabine IV over 1-3 hours twice daily (BID) on days 1, 3, and 5. Treatment repeats every 4 weeks for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients treated with liposome-encapsulated daunorubicin-cytarabine receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 5-8 weeks for 2 courses in the absence of disease progression, unacceptable toxicity.\n\nCytarabine: Given IV\n\nIdarubicin: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLiposome-encapsulated Daunorubicin-Cytarabine: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'BG001', 'title': 'Group II', 'description': 'LOW-INTENSITY: Patients receive venetoclax in combination with azacitidine or decitabine or other standard of care low-intensity therapy such as azacitidine or decitabine alone or in combination with FLT3 inhibitor such as midostaurin, low-dose cytarabine in combination with glasdegib.\n\nVenetoclax dose varies depending on drug interaction with antifungal agents. Given daily continuous for \\>= 3 months orally. Glasdegib dose is 100 mg oral daily.\n\nDecitabine IV over 1-3 hours daily for 5-10 days. Treatment repeats every 4-5 weeks for \\>= 3 courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant. Azacitidine IV infusion over 10 to 40 minutes days 1 -7. Treatment repeats every 4-5 weeks for \\>= 3 courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant.\n\nDecitabine: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nAzacitidine: Given by infusion\n\nVenetoclax: oral tablet\n\nglasdegib: oral tablet'}, {'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': '5', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Symptom Burden', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4.2'}, {'value': '16.7', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '16.7', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '50'}]}]}], 'paramType': 'MEDIAN', 'description': 'Each EORTC QLQ-C30 symptom sub-scale included here-Fatigue, Nausea/Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrhoea and Financial Difficulties-ranges from 0 (no symptom) to 100 (worst symptom). This instrument asks 28 questions about symptoms and their effects. Higher scores consistently indicate greater symptom burden. Multi-item scales are calculated by averaging their constituent items and then linearly transforming that mean to the 0-100 metric, while single-item scales are transformed directly without averaging.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Quality of Life as Measured by EORTC QLQ-C30 Version 3.0 at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '85.4'}, {'value': '50', 'groupId': 'BG001', 'lowerLimit': '33.3', 'upperLimit': '66.7'}, {'value': '50', 'groupId': 'BG002', 'lowerLimit': '33.3', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'description': 'The baseline value shown represents the Global Health Status (GHS) scale of the EORTC QLQ-C30, version 3.0, which is scored from 0 (worst possible overall health/quality of life) to 100 (best possible); thus, higher scores denote better outcomes. The GHS score for each participant is calculated by taking the arithmetic mean of QLQ-C30 items 29 and 30 and then linearly transforming that mean to the 0 - 100 metric specified in the EORTC scoring manual.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline Functional Status', 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000', 'lowerLimit': '80', 'upperLimit': '100'}, {'value': '80', 'groupId': 'BG001', 'lowerLimit': '60', 'upperLimit': '100'}, {'value': '80', 'groupId': 'BG002', 'lowerLimit': '60', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'description': "Karnofsky Performance Status (KPS) ranges from 0 to 100 in 10-point increments; higher scores indicate better functional ability. 'Full Range' reflects the observed minimum and maximum for each arm and for the overall cohort.", 'unitOfMeasure': 'score (0-100 scale)', 'dispersionType': 'FULL_RANGE'}, {'title': 'Baseline Functional Status Measure by Geriatric Assessment', 'classes': [{'title': 'Katz ADL Index', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '6', 'upperLimit': '6'}, {'value': '6', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '6'}, {'value': '6', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '6'}]}]}, {'title': 'Lawton IADL Index', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000', 'lowerLimit': '8', 'upperLimit': '8'}, {'value': '8', 'groupId': 'BG001', 'lowerLimit': '8', 'upperLimit': '8'}, {'value': '8', 'groupId': 'BG002', 'lowerLimit': '8', 'upperLimit': '8'}]}]}, {'title': 'SPPB', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '11'}, {'value': '7', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '9'}, {'value': '7', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '11'}]}]}], 'paramType': 'MEDIAN', 'description': 'Assessed using multiple tools from the geriatric assessment. Katz ADL ranges 0-6 (sum of six basic ADLs scored 0 = dependent, 1 = independent); higher = better basic self-care. Lawton IADL ranges 0-8 (sum of eight instrumental tasks, same 0/1 scoring); higher = better community functioning. SPPB ranges 0-12, adding three test sub-scores (balance, gait speed, chair stands each 0-4); higher = better lower-extremity performance. Each tool is interpreted on its own; no composite score is generated.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Neurocognitive Status by MoCA at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '29'}, {'value': '23', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '24'}, {'value': '23', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '29'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Montreal Cognitive Assessment (MoCA) is scored from 0 to 30, where higher scores reflect better cognition. Standard cut-points are ≥ 26 = normal, 18 - 25 = mild cognitive impairment, 10 - 17 = moderate impairment, and \\< 10 = severe impairment; no additional weighting or transformations are applied-the final score is the direct sum of item points across the 10 cognitive domains assessed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-21', 'size': 135654, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-01T17:21', 'hasProtocol': True}, {'date': '2022-03-17', 'size': 432754, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-03-14T15:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2017-07-19', 'resultsFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-15', 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Complete Remission and Mortality in the Entire Cohort of Older Patients', 'timeFrame': 'At 90 days', 'description': 'All analyses will be performed based on intent-to-treat principle. The method of inversion will be used to generate an interval estimate for the proportion of 90-day mortality.'}], 'secondaryOutcomes': [{'measure': 'Rate of Complete Remission and Mortality in Subsets of Older Patients Who Receive Intensive and Low-intensity Chemotherapy', 'timeFrame': 'At 90 days', 'description': 'All analyses will be performed based on intent-to-treat principle. The method of inversion will be used to generate an interval estimate for the proportion of 90-day mortality.'}, {'measure': 'Baseline Functional Status Measure by Geriatric Assessment', 'timeFrame': 'At 90 days', 'description': 'Will assess the impact of baseline functional status on the rate of complete remission and mortality.'}, {'measure': 'Baseline Functional Status', 'timeFrame': 'Up to 90 days', 'description': 'Will evaluate the influence of baseline functional status on the quality of life and neurocognitive status. The association between categories of functional status and quality of life will be explored using analysis of variance (ANOVA); if assumptions of ANOVA fail, Kruskal Wallis will be used. The association between functional status (fit or vulnerable) and neurocognitive status (\\< 25 or 26 or higher) will be explored using a chi-square test. A generalized linear mixed model will be utilized to evaluate changes in quality of life over time. The proportion (and associated 95% confidence interval) of patients with definitely or probably modifiable impairments will be presented.'}, {'measure': 'Symptom Burden', 'timeFrame': 'Baseline (diagnosis), 10, 30 and 90 days following initiation of chemotherapy', 'description': 'Symptom burden will be determined using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30) at four time points. This instrument asks 28 questions about symptoms and their effects which are scored 1 to 4. Higher scores indicate worse symptoms and effects. Two additional questions ask about overall health and quality of life during the past week and are scored 1 to 7. Higher scores indicate better weekly health and quality of life.'}, {'measure': 'Mortality at 90 Days', 'timeFrame': 'Up to 90 days from diagnosis', 'description': 'Mortality at 90 days will be calculated from date of diagnosis to date of death due to any cause within 90 days from diagnosis.'}, {'measure': 'Quality of Life as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire', 'timeFrame': 'Several time points after completion of treatment, up to 2 years', 'description': 'The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), Version 3.0, will be given at several time points in follow-up after completion of treatment. The instrument assesses cancer patients\' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items.\n\nA linear transformation is used to standardise the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. The scores will be utilized to determine quality of life status will be used to evaluate changes in quality of life over time.'}, {'measure': 'Neurocognitive Status as Measured by the Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'Several time points after completion of treatment, up to 2 years', 'description': 'The Montreal Cognitive Assessment (MoCA) will be given at several time points in follow-up after completion of treatment. The instrument assesses different cognitive domains, including attention, visuospatial skills, executive functions, memory, language, and abstract thinking. Each task has a specific scoring guide, with points awarded based on performance. Composite scores of 26-30 generally indicates normal cognitive function, 18-25 suggests mild cognitive impairment, 10-17 indicates moderate impairment, and scores below 10 point to severe cognitive impairment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adult Acute Myeloid Leukemia', 'Secondary Acute Myeloid Leukemia', 'Therapy-Related Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '40298352', 'type': 'DERIVED', 'citation': 'Bhatt VR, Wichman CS, Koll TT, Fisher AL, Wildes TM, Haddadin M, Berger AM, Armitage JO, Holstein SA, Maness LJ, Gundabolu K. A Phase II Trial of Geriatric Assessment-Guided Selection of Treatment Intensity in Older Adults With AML. Am J Hematol. 2025 Jul;100(7):1163-1172. doi: 10.1002/ajh.27694. Epub 2025 Apr 29.'}, {'pmid': '38000343', 'type': 'DERIVED', 'citation': 'Bhatt VR, Wichman C, Koll TT, Fisher AL, Wildes TM, Berger A, Armitage JO, Holstein SA, Maness LJ, Gundabolu K. Longitudinal changes in cognitive and physical function and health-related quality of life in older adults with acute myeloid leukemia. J Geriatr Oncol. 2024 Jan;15(1):101676. doi: 10.1016/j.jgo.2023.101676. Epub 2023 Nov 24.'}, {'pmid': '35450817', 'type': 'DERIVED', 'citation': 'Bhatt VR, Wichman C, Al-Kadhimi ZS, Koll TT, Fisher AL, Mahato RI, Hyde RK, Berger A, Armitage JO, Holstein SA, Maness LJ, Gundabolu K. Integrating geriatric assessment and genetic profiling to personalize therapy selection in older adults with acute myeloid leukemia. J Geriatr Oncol. 2022 Jul;13(6):871-874. doi: 10.1016/j.jgo.2022.04.005. Epub 2022 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'Acute myeloid leukemia (AML) is among the most common hematologic malignancies in adults and accounts for approximately 10,000 deaths in the United States every year. AML is commonly diagnosed in sixth or seventh decades of life. The management of AML is complex in older patients because of associated comorbidities, intolerance to high-dose chemotherapy and high-risk tumor biology. In real world practice, over one-third of patients aged 60 years and older do not receive initial chemotherapy for AML, consequently, only 10-20% of patients are alive at 3-5 years. Longer-term survival has not improved significantly in last few decades. Poor survival of older patients with AML may be improved with refined risk-stratification and therapy selection strategies, integration of principles of geriatric medicine, and use of effective but low intensity and novel therapies.\n\nThis study will examine the impact of clinicogenetic risk-stratified management on outcomes of acute myeloid leukemia in older participants (≥ 60 years) with newly diagnosed acute myeloid leukemia who receive clinicogenetic risk-stratified therapy allocation. Participants will receive standard of care intensive or low-intensity induction based on cytogenetic and geriatric assessment-based risk stratification. Participants will be evaluated for disease status, survival, quality of life and neurocognitive status for 90 days and then followed for a total of 2 years for survival data.', 'detailedDescription': 'Acute myeloid leukemia (AML) is among the most common hematologic malignancies in adults and accounts for approximately 10,000 deaths in the United States every year. AML is commonly diagnosed in sixth or seventh decades of life. The management of AML is complex in older patients because of associated comorbidities, intolerance to high-dose chemotherapy and high-risk tumor biology. The current approach for therapy selection is largely subjective based on chronological age, performance status and/or comorbidities, and does not clearly identify patients who should undergo or forego intensive chemotherapy. The outcomes of older patients with high-risk AML can improve with enhanced risk-stratification and therapy selection strategies, and with the use of low intensity combination chemotherapy in patients who are not fit to receive intensive chemotherapy.\n\nComprehensive geriatric assessment offers a thorough assessment of multiple health domains including comorbidities, polypharmacy, cognitive, nutritional, psychological, functional and social status. Such multidimensional assessment based on geriatric principles is an important tool that can improve risk-stratification and therapy selection in older patients. This approach provides a deeper understanding of the biological age and physical fitness of patients, and anticipated tolerance to chemotherapy. In older patients with AML, previous studies have demonstrated that comprehensive geriatric assessment uncovers significant functional impairments and predicts toxicities and overall survival. Hence, geriatric assessment is considered superior to therapy allocation based on assessment of age and performance status.\n\nUp to 75 participants newly diagnosed with AML or AML equivalents, such as myeloid sarcoma, myelodysplastic syndrome in transition to AML or high-grade treatment-related myeloid neoplasm will be enrolled and assigned to one of two groups based on cytogenetic and geriatric assessment-based risk stratification. Group I will receive intensive induction and consolidation therapy. Participants will receive cytarabine and idarubicin or liposome-encapsulated daunorubicin-cytarabine to which gemtuzumab or midostaurin will be added for one course of treatment in the absence of disease progression or unacceptable toxicity. Participants who go into remission will then receive either cytarabine or liposome-encapsulated daunorubicin-cytarabine, depending on induction therapy, for up to 4 or 8 courses in the absence of disease progression or unacceptable toxicity. Group II will receive low-intensity induction and consolidation therapy. Participants will receive oral venetoclax and azacitidine, decitabine or alternate standard of care low-intensity therapies up to four courses in the absence of disease progression or unacceptable toxicity. Participants who achieve complete remission will then receive the above treatments for three or more courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant. All participants are followed up for up to 2 years after completion of treatment.\n\nStudy objectives include determining the rate of complete remission and mortality at 90 days in participants who receive clinicogenetic risk-stratified therapy allocation, determining the rate of complete remission and mortality in participants who receive intensive versus low-intensity chemotherapy, determining proportion of participants with impairments detected by geriatric assessment, determining the percentage of older participants receiving allogeneic stem cell transplant during the study, and to assessing the overall survival at 1-year for the entire cohort of participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* New diagnosis of de novo, secondary or treatment-related acute myeloid leukemia (AML), other AML equivalent such as myeloid sarcoma, myelodysplastic syndrome in transformation to AML, or high-grade treatment-related myeloid neoplasm\n* 60 years of age or older\n* Karnofsky Performance Status ≥60%\n* Able and willingly give signed informed consent\n\nExclusion criteria:\n\n* Acute promyelocytic leukemia (APL). Participants with brief exposure to all-trans retinoic acid (ATRA), arsenic trioxide (ATO) or similar product for suspected APL, who later turn out not to have APL, are eligible.\n* Relapsed or refractory acute myeloid leukemia (AML) requiring salvage therapy\n* Prior exposure to decitabine or azacitidine (exclusion criterion for use of decitabine or azacitidine)\n* Participants requiring urgent initiation of chemotherapy for leukemia-related emergencies such as leukostasis or disseminated intravascular coagulopathy Participants will not be excluded solely based on current or prior use of debulking agent (e.g., hydroxyurea or cyclophosphamide). Prior or current use of leukapheresis will be allowed.\n* Uncontrolled serious infection at enrollment. Infections are considered controlled if appropriate therapy has been instituted and, at enrollment, participants do not have signs of infection progression (e.g., hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection). Persistent fever without other signs or symptoms will not be interpreted as progressing infection.\n* Uncontrolled clinically significant arrhythmia, myocardial ischemia or congestive heart failure within the past 2 weeks, that is considered a contraindication for initiation of chemotherapy by the treating physician\n* Ejection fraction \\< 45% will be an exclusion criterion for intensive chemotherapy. These participants may receive low intensity therapy.\n* Clinically significant kidney (e.g., glomerular filtration rate (GFR) ≤ 45ml/minute or creatinine of ≥2 mg/dl) or liver dysfunction \\[e.g., aspartate aminotransferase (AST)/alanine aminotransferase (ALT) and/or bilirubin ≥2 times upper limit of normal (ULN)\\] at enrollment that may prevent safe use of chemotherapy. These participants may be allowed to receive low-intensity chemotherapy. Participants with elevated bilirubin secondary to Gilbert syndrome will not be excluded.\n* Any other condition that may not allow safe use of chemotherapy based on clinical judgment of treating oncologist'}, 'identificationModule': {'nctId': 'NCT03226418', 'briefTitle': 'Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'A Phase II Study of the Impact of Clinicogenetic Risk-Stratified Management on Outcomes of Acute Myeloid Leukemia in Older Patients', 'orgStudyIdInfo': {'id': '0179-17-FB'}, 'secondaryIdInfos': [{'id': 'NCI-2017-01285', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'P30CA036727', 'link': 'https://reporter.nih.gov/quickSearch/P30CA036727', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I Intensive Induction and Consolidation Therapies', 'description': 'Intensive Induction Therapy: Participants receive cytarabine intravenously (IV) on days 1-7 and idarubicin over 10-15 minutes on days 1-3 (7+3), or liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3 and 5. Gemtuzumab or midostaurin is added to 7+3 as per the standard of care. Treatment continues for 1 course in the absence of unacceptable toxicity.\n\nIntensive Consolidation Therapy: Participants who go into remission, receive cytarabine IV over 1-3 hours twice daily (BID) on days 1, 3, and 5. Treatment repeats every 4 weeks for 2-4 courses in the absence of disease progression or unacceptable toxicity. Participants treated with liposome-encapsulated daunorubicin-cytarabine receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 5-8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Cytarabine', 'Drug: Idarubicin', 'Other: Laboratory Biomarker Analysis', 'Drug: Liposome-encapsulated Daunorubicin-Cytarabine', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Group II Low-intensity Induction and Consolidation Therapies', 'description': 'Low-intensity: Participants receive venetoclax in combination with azacitidine or decitabine or other standard of care low-intensity therapy such as azacitidine or decitabine alone or in combination with fms-like tyrosine kinase 3 (FLT3) inhibitor such as midostaurin, low-dose cytarabine in combination with glasdegib. Venetoclax dose varies depending on drug interaction with anti-fungal agents. Given daily continuous for 3 or more months orally. Glasdegib dose is 100 mg oral daily.\n\nDecitabine intravenously (IV) over 1 - 3 hours daily for 5 - 10 days. Treatment repeats every 4 - 5 weeks for 3 or more courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant. Azacitidine IV infusion over 10 to 40 minutes days 1 - 7. Treatment repeats every 4 - 5 weeks for 3 or more courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant.', 'interventionNames': ['Drug: Decitabine', 'Other: Laboratory Biomarker Analysis', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Drug: Azacitidine', 'Drug: Venetoclax', 'Drug: glasdegib']}], 'interventions': [{'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['.beta.-Cytosine arabinoside', '1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone', '1-.beta.-D-Arabinofuranosylcytosine', '1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone', '1-Beta-D-arabinofuranosylcytosine', '1.beta.-D-Arabinofuranosylcytosine', '2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-', '2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-', 'Alexan', 'Ara-C', 'ARA-cell', 'Arabine', 'Arabinofuranosylcytosine', 'Arabinosylcytosine', 'Aracytidine', 'Aracytin', 'Aracytine', 'Beta-cytosine Arabinoside', 'CHX-3311', 'Cytarabinum', 'Cytarbel', 'Cytosar', 'Cytosine Arabinoside', 'Cytosine-.beta.-arabinoside', 'Cytosine-beta-arabinoside', 'Erpalfa', 'Starasid', 'Tarabine PFS', 'U 19920', 'U-19920', 'Udicil', 'WR-28453'], 'description': 'Given IV', 'armGroupLabels': ['Group I Intensive Induction and Consolidation Therapies']}, {'name': 'Decitabine', 'type': 'DRUG', 'otherNames': ["5-Aza-2'-deoxycytidine", 'Aza-TdC', 'Dacogen', 'Decitabine for Injection', 'Deoxyazacytidine', 'Dezocitidine'], 'description': 'Given IV', 'armGroupLabels': ['Group II Low-intensity Induction and Consolidation Therapies']}, {'name': 'Idarubicin', 'type': 'DRUG', 'otherNames': ['4-Demethoxydaunomycin', '4-demethoxydaunorubicin', '4-DMDR'], 'description': 'Given IV', 'armGroupLabels': ['Group I Intensive Induction and Consolidation Therapies']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Group I Intensive Induction and Consolidation Therapies', 'Group II Low-intensity Induction and Consolidation Therapies']}, {'name': 'Liposome-encapsulated Daunorubicin-Cytarabine', 'type': 'DRUG', 'otherNames': ['CPX-351', 'Cytarabine-Daunorubicin Liposome for Injection', 'Liposomal AraC-Daunorubicin CPX-351', 'Liposomal Cytarabine-Daunorubicin', 'Liposome-encapsulated Combination of Daunorubicin and Cytarabine', 'Vyxeos'], 'description': 'Given IV', 'armGroupLabels': ['Group I Intensive Induction and Consolidation Therapies']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Group I Intensive Induction and Consolidation Therapies', 'Group II Low-intensity Induction and Consolidation Therapies']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I Intensive Induction and Consolidation Therapies', 'Group II Low-intensity Induction and Consolidation Therapies']}, {'name': 'Azacitidine', 'type': 'DRUG', 'otherNames': ['VIDAZA'], 'description': 'Given by infusion', 'armGroupLabels': ['Group II Low-intensity Induction and Consolidation Therapies']}, {'name': 'Venetoclax', 'type': 'DRUG', 'otherNames': ['Venclexta, Venclyxto'], 'description': 'oral tablet', 'armGroupLabels': ['Group II Low-intensity Induction and Consolidation Therapies']}, {'name': 'glasdegib', 'type': 'DRUG', 'otherNames': ['Daurismo'], 'description': 'oral tablet', 'armGroupLabels': ['Group II Low-intensity Induction and Consolidation Therapies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Vijaya R Bhatt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}