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

Not Applicable

Completed

• Conditions: ACUTE MYELOGENOUS LEUKEMIA
• Interventions: Other: Bedside assessment

• Registration Number: NCT02662933
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

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Exclusion Criteria

• Requiring intensive care unit support during initial evaluation
• Prior therapy for AML
• ECOG score >3

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bedside Assessment Measures	Bedside assessment	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 Outcome Measures

Name	Time	Method
Overall Survival	27 months	Overall survival will be measured in months from the date of initial AML diagnosis.

Secondary Outcome Measures

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