Investigating the Relationship Between Physical Function, Comorbidity and Cytogenetic Risk Group in Older Adults With Acute Myelogenous Leukemia (AML)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 82
- Primary Endpoint
- Overall Survival
Study Overview
Brief Summary
AML is a disease of older adults, with a median age at diagnosis of 67 years . An estimated 13,410 new cases of AML will be diagnosed in 2007. Survival for AML is age-dependent, with significantly lower survival rates reported for older adults. SEER statistics from 1996-2003 show a 5 year relative survival rate of 34.4% for adults younger than 65 and 4.3% for those ≥65 years of age 1. Clinical trials have demonstrated worse survival outcomes in older adults with AML using age cutoffs of 55, 60 and 65 years. Older adults have also experienced increased toxicity to standard therapies in clinical trials. Chronologic age cutoffs have therefore been used in research and clinical practice due to concerns regarding toxicity associated with treatment. The reasons for the increased toxicity and decreased survival in older adults with AML is incompletely understood and likely multifactorial including both tumor specific and host specific factors. Improving understanding of which measurable clinical characteristics predict vulnerability to toxicity will help refine the research and clinical approach to older adults with AML.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Capacity to provide signed protocol specific informed consent
- •Age ≥ 60 years
- •Pathologically confirmed newly diagnosed AML or undergoing workup for suspected AML
- •Planned induction chemotherapy
- •Inpatient status
Exclusion Criteria
- •Requiring intensive care unit support during initial evaluation
- •Prior therapy for AML
- •ECOG score >3
Outcomes
Primary Outcomes
Overall Survival
Time Frame: 27 months
Overall survival will be measured in months from the date of initial AML diagnosis.
Secondary Outcomes
- Treatment Related Mortality(30 days)
