Geriatric Assessment-Guided Treatment Selection in Older Adults With Acute Myeloid Leukemia (The ALIGN-AML Trial)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- University of Rochester
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Treatment failure rate at 3 months
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 60 and above
- •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
- •AML diagnosis can be based on the World Health Organization (WHO) 2022 criteria or International Consensus Classification (ICC) 2022 criteria
- •The use of hydroxyurea, cytarabine (up to 1 gm total dose), or leukapheresis for cytoreduction is allowed
- •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
- •The use of other cancer-directed treatments (e.g., hormonal treatment, targeted treatment, immunotherapy, radiation) other than chemotherapy for other concurrent malignancies is allowed
- •Able to provide informed consent
Exclusion Criteria
- •Acute promyelocytic leukemia
- •Unwilling to complete study procedures
Outcomes
Primary Outcomes
Treatment failure rate at 3 months
Time Frame: 3 months after treatment initiation
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.
Secondary Outcomes
- Treatment failure rate at 6 months(6 months after treatment initiation)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety(Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90)
- Overall Response Rate(6 months after treatment initiation)
- Overall survival(Up to 2 years after randomization)
- Event-free survival(Up to 2 years after randomization)
- Grade 3-5 toxicities(6 months after treatment initiation)
- Unplanned hospitalizations(6 months after treatment initiation)
- Activities of Daily Living (ADL)(Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90)
- Instrumental Activities of Daily Living (IADL)(Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90)
- Fall History(Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90)
- Short Physical Performance Battery (SPPB)(Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90)
- Montreal Cognitive Assessment (MoCA)(Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90)
- Geriatric Depression Scale-15 (GDS-15)(Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90)
- Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)(Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90, day 180, day 360)
- Patient Reported Toxicities(Baseline, during Cycle 1, at the start of Cycle 2 (or consolidation), Day 90, and Day 180. 28 day cycle)
Investigators
Kah Poh Loh
Associate Professor - Department of Medicine, Hematology/Oncology (SMD)
University of Rochester