Geriatric Assessment-Guided Treatment Selection in Older Adults With Acute Myeloid Leukemia

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.

This 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.

• Treatment failure rate at 6 months [Time frame: 6 months after treatment initiation]
• Overall Response Rate [Time frame: 6 months after treatment initiation]
• Overall survival [Time frame: Up to 2 years after randomization]
• Event-free survival [Time frame: Up to 2 years after randomization]
• Grade 3-5 toxicities [Time frame: 6 months after treatment initiation]
• Unplanned hospitalizations [Time frame: 6 months after treatment initiation]
• Activities of Daily Living (ADL) [Time frame: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90]
• Instrumental Activities of Daily Living (IADL) [Time frame: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90]
• Fall History [Time frame: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90]
• Short Physical Performance Battery (SPPB) [Time frame: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90]
• Montreal Cognitive Assessment (MoCA) [Time frame: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90]
• Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety [Time frame: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90]