Investigating the Relationship Between Physical Function, Comorbidity and Cytogenetic Risk Group in Older Adults With Acute Myelogenous Leukemia (AML)
This trial has been completed.
|Condition||acute myelogenous leukemia|
|Sponsor||Wake Forest University Health Sciences|
|Start date||January 2009|
|End date||April 2011|
|Trial size||82 participants|
|Trial identifier||NCT02662933, CCCWFU 22A08|
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.
|Intervention model||single group assignment|
|Primary purpose||supportive care|
time frame: 27 months
Treatment Related Mortality
time frame: 30 days
All participants at least 60 years old.
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
|Official title||Investigating the Relationship Between Physical Function, Comorbidity and Cytogenetic Risk Group in Older Adults With Acute Myelogenous Leukemia (AML)|
|Principal investigator||Heidi Klepin, MD|
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