Geriatric Assessment-Guided Treatment Selection in Older Adults With Acute Myeloid Leukemia | NCT07735208

NCT07735208

Overview

NCT ID: NCT07735208
Lead Sponsor: University of RochesterOTHER
Official Title: Geriatric Assessment-Guided Treatment Selection in Older Adults With Acute Myeloid Leukemia (The ALIGN-AML Trial)
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.
Conditions: Acute Myeloid Leukemia
Interventions: GA-directed treatment regimens

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Dec 1, 2026Estimated
Primary Completion Date: Nov 30, 2031Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 120Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Kah Poh (Melissa) Loh, MD, MSContact
Kahpoh_Loh@URMC.Rochester.edu

Similar Studies

Participant Group/Arms

GA-guided treatment ArmExperimental

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.

Drug: GA-directed treatment regimens

Usual Care/Control ArmNo 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.