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Clinical Trials/NCT02662933
NCT02662933CompletedNot Applicable

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

Wake Forest University Health Sciences0 sites82 target enrollmentStarted: January 2009Last updated:
Conditions

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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