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

NCT07735208 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: UMLEU26044
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

AML; Geriatric Assessment; Acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (15)

• Treatment failure rate at 6 months

  6 months after treatment initiation

• 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

Study Arms (2)

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.

Drug: GA-directed treatment regimens

Usual Care/Control 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.

Interventions

GA-directed treatment regimens DRUG

Fit, vulnerable, and frail patients will receive predefined regimens based on their GA results.

GA-guided treatment Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Acute promyelocytic leukemia
• Unwilling to complete study procedures

Sponsors & Collaborators

• University of Rochester: lead
• Rising Tide Foundation: collaborator

Study Sites (1)

University of Rochester Medicine

Rochester, New York, 14642, United States

Location

Related Publications (1)

• 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/ajh.27694. Epub 2025 Apr 29.

  PMID: 40298352 BACKGROUND

Related Links

• National Cancer Institute Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Leukemia - Acute Myeloid Leukemia (AML), 2025

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Kah Poh (Melissa) Loh, MD, MS

CONTACT

585-275-5863; Kahpoh_Loh@URMC.Rochester.edu

Clinical Trials Office

CONTACT

585-275-5863; wcictoresearch@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Department of Medicine, Hematology/Oncology (SMD)

Model Details: Patients will be randomized 1:1 to the intervention or usual care arms using stratified randomized block design. Stratum will be defined by institution and fitness categories (fit, vulnerable, frail).

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): November 30, 2031
• Study Completion (Estimated): November 30, 2031
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)