About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Acute promyelocytic leukemia
Unwilling to complete study procedures
Trial design
Treatments tested in this trial
- GA-directed treatment regimens
Treatment groups
Sponsors and collaborators
University of Rochester
Lead sponsor
Rising Tide Foundation
Collaborator