[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649433":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":34,"responsibleParty":50,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":80,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University of Rochester","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GA-guided treatment Arm","EXPERIMENTAL","Participants will undergo a Practical Geriatric Assessment (PGA). Based on specific domains and measures within the PGA, participants will be categorized as fit, vulnerable, or frail and will receive treatment tailored to their physiologic status.",[13],"Drug: GA-directed treatment regimens",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care\u002FControl Arm","NO_INTERVENTION","Participants will undergo a structured Geriatric Assessment (GA) to determine physiologic fitness using the Practical Geriatric Assessment (PGA) and receive therapy determined by their treating oncologist not based on the GA results.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","GA-directed treatment regimens","Fit, vulnerable, and frail patients will receive predefined regimens based on their GA results.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Kah Poh (Melissa) Loh, MD, MS","CONTACT","585-275-5863","Kahpoh_Loh@URMC.Rochester.edu",{"name":32,"role":28,"phone":29,"phoneExt":18,"email":33},"Clinical Trials Office","wcictoresearch@urmc.rochester.edu",[35],{"facility":36,"status":18,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"University of Rochester Medicine","Rochester","New York","14642","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-77.61556,43.15478,{"lat":46,"lon":45},[49],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Kah Poh Loh","Associate Professor - Department of Medicine, Hematology\u002FOncology (SMD)",[55],{"name":56,"class":6},"Rising Tide Foundation","100649433","phase-2-geriatric-assessment-guided-treatment-selection-in-older-adults-with-acute-myeloid-leukemia-100649433",false,"NCT07735208","Geriatric Assessment-Guided Treatment Selection in Older Adults With Acute Myeloid Leukemia","Geriatric Assessment-Guided Treatment Selection in Older Adults With Acute Myeloid Leukemia (The ALIGN-AML Trial)","ALIGN-AML","Inclusion Criteria:\n\n1. Age 60 and above\n2. A 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\n\n   1. AML diagnosis can be based on the World Health Organization (WHO) 2022 criteria or International Consensus Classification (ICC) 2022 criteria\n   2. The use of hydroxyurea, cytarabine (up to 1 gm total dose), or leukapheresis for cytoreduction is allowed\n   3. Patients with brief exposure to all-trans retinoic acid (ATRA), arsenic trioxide (ATO) or similar product for suspected acute promyelocytic leukemia (APL), who later turn out not to have APL, are eligible\n   4. The use of other cancer-directed treatments (e.g., hormonal treatment, targeted treatment, immunotherapy, radiation) other than chemotherapy for other concurrent malignancies is allowed\n3. Able to provide informed consent\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia\n2. Unwilling to complete study procedures","ALL","60 Years",{"count":68,"type":69},120,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","This is a phase 2 randomized controlled trial to evaluate whether a geriatric assessment (GA)-guided treatment strategy reduces treatment-related toxicity and improves patient-centered outcomes compared with usual oncologist-directed care in adults aged 60 years and older with newly diagnosed AML.",[75],"Acute Myeloid Leukemia",[77,78,79],"AML","Geriatric Assessment","Acute myeloid leukemia","NOT_YET_RECRUITING","2026-07-24",{"date":83,"type":84},"2026-07-29","ACTUAL",{"date":86,"type":69},"2026-12-01",{"date":88,"type":69},"2031-11-30",{"name":5,"class":6},1]