Investigating the Relationship Between Physical Function, Comorbidity and Cytogenetic Risk Group in Older Adults With Acute Myelogenous Leukemia (AML)

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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bedside assessment

Other

The study intervention consists of a bedside functional assessment to be administered to eligible, consented subjects who are hospitalized with a new diagnosis of AML or are undergoing workup for suspected AML diagnosis. All subjects will be enrolled within 5 days of admission to the hospital for known or suspected AML or within 5 days of new confirmed diagnosis of AML obtained during a hospitalization for other indications. All measures will be performed by a trained examiner during a face to face interview.

Bedside assessment measures will be repeated once for subjects who complete induction chemotherapy within 2-8 weeks post discharge from initial hospitalization.

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

Time frame: 30 days

Treatment-related mortality, defined as death within 30 days of chemotherapy initiation, will provide a general measure of treatment-related toxicity.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Jan 26, 2016
Registry last updated: Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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