[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07735208":3,"trial-entities:NCT07735208":136,"trial-summary:NCT07735208":141},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":94,"minimum_age":95,"maximum_age":96,"healthy_volunteers":97,"eligibility_criteria":98,"std_ages":102,"locations":105,"central_contacts":121,"overall_officials":126,"references":127,"see_also_links":132},"NCT07735208","UMLEU26044","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)","NOT_YET_RECRUITING","2031-11-30","2026-07","2026-07-29","2026-12-01","University of Rochester","OTHER",true,"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.","Acute myeloid leukemia (AML) primarily affects older adults, yet treatment decision-making in this population remains largely inconsistent. Older adults with AML are highly heterogeneous with respect to physiologic reserve, functional status, cognition, and comorbidities, all of which strongly influence treatment tolerance and outcomes. Despite this heterogeneity, treatment decisions are often made rapidly and rely heavily on chronological age and clinician judgment, approaches that have been repeatedly shown to inadequately predict toxicity, early mortality, and functional decline. The proposed trial addresses a critical scientific question: whether a structured geriatric assessment (GA)-guided treatment strategy improves clinically meaningful outcomes compared with usual oncologist-directed care in older adults with AML. Although GA has been extensively validated as a prognostic and risk stratification tool in oncology and has improved care delivery in solid tumors, it has not been tested in a randomized controlled trial in AML, where treatment urgency, toxicity burden, and early adverse events are especially pronounced. This study therefore fills a major evidence gap at the intersection of geriatric oncology and hematologic malignancies.\n\nThis multicenter, prospective, randomized controlled trial is designed to evaluate whether a geriatric assessment (GA)-guided treatment strategy improves clinically meaningful outcomes compared with usual oncologist-directed care in older adults with newly diagnosed acute myeloid leukemia (AML). Approximately 120 adults aged 60 years and older will be enrolled across 3 academic and community institutions affiliated with the Cancer and Aging Research Group (CARG). Patients will be randomized in a 1:1 ratio to either a GA-guided treatment arm or a usual-care arm, with randomization stratified by study site and GA-defined fitness category (fit, vulnerable, frail). All patients will undergo a structured GA using the Practical Geriatric Assessment recommended by the American Society of Clinical Oncology and adapted for hematologic malignancies. However, GA results will be used to guide treatment selection only for participants assigned to the intervention arm.",[19],"Acute Myeloid Leukemia",[21,22,23],"AML","Geriatric Assessment","Acute myeloid leukemia","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},120,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","GA-directed treatment regimens","Fit, vulnerable, and frail patients will receive predefined regimens based on their GA results.",[37],"GA-guided treatment Arm",[39],{"measure":40,"description":41,"timeFrame":42},"Treatment failure rate at 3 months","Treatment failure is defined as the occurrence of any of the following within 3 months after treatment initiation: disease progression or relapse, death from any cause, treatment discontinuation for any reason except logistical reasons, absence of at least one agent in the initial treatment regimen for more than 30 days following the last day of the previous treatment cycle (temporary dose interruptions and cycle delays within the 30 day window are not considered treatment failure events), or initiation of an alternative treatment regimen or addition of an agent because of clinician documented concern for lack of efficacy or disease control.","3 months after treatment initiation",[44,48,51,55,58,61,64,68,71,74,77,80,83,86,90],{"measure":45,"description":46,"timeFrame":47},"Treatment failure rate at 6 months","Treatment failure will be assessed at 6 months (180 days) after treatment initiation and include any of the following events: • Disease progression or relapse • Death from any cause • Treatment discontinuation for any reason (except logistical) • Treatment delays, defined as: o Absence of at least one agent in the initial regimen for \\>30 days following the last day of prior treatment cycle o Temporary dose interruptions and cycle delays within the 30-day window are not considered treatment failure events • Initiation of an alternative treatment regimen or addition of an agent to the initial regimen due to clinician-documented concern for lack of efficacy or disease control, including but not limited to: o Failure to achieve the expected response o Rising blast percentage or worsening cytopenias attributed to disease o Loss of a prior response","6 months after treatment initiation",{"measure":49,"description":50,"timeFrame":47},"Overall Response Rate","Best overall response from the initial treatment regimen within the first 6 months after treatment initiation. Overall response includes complete remission (CR), complete remission with incomplete hematologic recovery (CRi), and complete remission with partial hematologic recovery (CRh), assessed according to the European LeukemiaNet (ELN) 2022 response criteria.",{"measure":52,"description":53,"timeFrame":54},"Overall survival","Time from randomization to death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive.","Up to 2 years after randomization",{"measure":56,"description":57,"timeFrame":54},"Event-free survival","Time from randomization to the first occurrence of failure to achieve complete remission (CR), complete remission with incomplete hematologic recovery (CRi), or complete remission with partial hematologic recovery (CRh), relapse after achieving CR, CRi, or CRh, or death from any cause.",{"measure":59,"description":60,"timeFrame":47},"Grade 3-5 toxicities","Proportion of participants with Grade 3 or higher nonhematologic adverse events and Grade 3 or higher neutropenia, thrombocytopenia, or anemia associated with the initial treatment regimen, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Asymptomatic laboratory abnormalities lasting 7 days or less that do not result in a dose modification or treatment hold will not be included.",{"measure":62,"description":63,"timeFrame":47},"Unplanned hospitalizations","Number of unplanned inpatient hospitalizations during the first 6 months after treatment initiation, excluding the initial hospitalization for treatment initiation.",{"measure":65,"description":66,"timeFrame":67},"Activities of Daily Living (ADL)","Change in Katz ADL total score from baseline. ADL measures independence in activities of daily living (including bathing, dressing, toileting, transferring, continence, and feeding). ADL ranges from 0 to 6, with higher scores representing greater independence in activities of daily living.","Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90",{"measure":69,"description":70,"timeFrame":67},"Instrumental Activities of Daily Living (IADL)","Change in OARS IADL total score from baseline. IADL measures independence in instrumental activities of daily living (including using the telephone, travel, shopping, meal preparation, housework, taking medications, and handling money). IADL ranges from 0 to 14, with higher scores representing greater independence in instrumental activities of daily living.",{"measure":72,"description":73,"timeFrame":67},"Fall History","Change in number of falls from baseline. More falls represent worse physical function.",{"measure":75,"description":76,"timeFrame":67},"Short Physical Performance Battery (SPPB)","Change in SPPB total score from baseline. SPPB measures physical function and ranges from 0 to 12 (higher scores represent greater physical function).",{"measure":78,"description":79,"timeFrame":67},"Montreal Cognitive Assessment (MoCA)","Change in MoCA total score from baseline. MoCA measure cognitive function and ranges from 0 to 30 (higher scores represent greater cognitive function).",{"measure":81,"description":82,"timeFrame":67},"Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety","Change in PROMIS Anxiety 4a total score from baseline. PROMIS Anxiety measures anxiety and ranges from 4 to 20 (higher scores represent greater anxiety).",{"measure":84,"description":85,"timeFrame":67},"Geriatric Depression Scale-15 (GDS-15)","Change in GDS-15 total score from baseline. GDS-15 measures depression and ranges from 0 to 15 (higher scores represent greater depression).",{"measure":87,"description":88,"timeFrame":89},"Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)","Change in FACT-Leu total score from baseline. FACT-Leu measures quality of life and is designed specifically for patients with leukemia. FACT-Leu ranges from 0 to 176, with higher scores representing better quality of life.","Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90, day 180, day 360",{"measure":91,"description":92,"timeFrame":93},"Patient Reported Toxicities","Change in patient reported symptomatic toxicities measured using the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO CTCAE). Responses will be assessed longitudinally at the protocol specified assessment time points.","Baseline, during Cycle 1, at the start of Cycle 2 (or consolidation), Day 90, and Day 180. 28 day cycle","ALL","60 Years",null,false,{"inclusion":99,"exclusion":100,"raw_text":101},[],[],"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",[103,104],"ADULT","OLDER_ADULT",[106],{"facility":107,"city":108,"state":109,"zip":110,"country":111,"contacts":112,"geoPoint":118},"University of Rochester Medicine","Rochester","New York","14642","United States",[113],{"name":114,"role":115,"phone":116,"email":117},"Kah Poh (Melissa) Loh, MD, MS","CONTACT","585-275-5863","Kahpoh_Loh@URMC.Rochester.edu",{"lat":119,"lon":120},43.15478,-77.61556,[122,123],{"name":114,"role":115,"phone":116,"email":117},{"name":124,"role":115,"phone":116,"email":125},"Clinical Trials Office","wcictoresearch@urmc.rochester.edu",[],[128],{"pmid":129,"type":130,"citation":131},"40298352","BACKGROUND","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\u002Fajh.27694. Epub 2025 Apr 29.",[133],{"label":134,"url":135},"National Cancer Institute Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Leukemia - Acute Myeloid Leukemia (AML), 2025","https:\u002F\u002Fseer.cancer.gov\u002Fstatfacts\u002Fhtml\u002Famyl.html",{"nct_id":4,"conditions":137,"biomarkers":140},[19,138,139],"Myelodysplastic Syndrome","Myeloid Sarcoma",[],{"nct_id":4,"found":15,"summary":142,"prompt_version":152},{"design":143,"status":144,"heading":145,"summary":146,"follow_up":147,"word_count":148,"commitments":149,"compensation":150,"drugs_mentioned":151},"This is a Phase 2 randomized controlled trial involving 120 participants. It compares a geriatric assessment-guided treatment strategy to usual oncologist-directed care.","completed","Geriatric Assessment for Older Adults with Acute Myeloid Leukemia","This study is for adults aged 60 and older who have been newly diagnosed with Acute Myeloid Leukemia (AML), a type of blood cancer. It's testing if using a \"geriatric assessment\" (GA) to guide treatment choices can reduce side effects and improve how you feel, compared to standard care. The GA helps doctors understand your overall health, not just your age. Depending on your GA results (fit, vulnerable, or frail), you would receive specific treatment regimens. The main goal is to see how many people experience treatment failure within 3 months. This study is currently unclear on its recruitment status.","The primary endpoint is measured at 3 months after treatment initiation to assess treatment failure rate.",100,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]