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

NCT ID: NCT02662933

Last Updated: 2023-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-04-30

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.

Conditions

ACUTE MYELOGENOUS LEUKEMIA

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Bedside Assessment Measures

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.

Group Type: EXPERIMENTAL

Bedside assessment

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heidi Klepin, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Other Identifiers

CCCWFU 22A08

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00007722

Identifier Type: -

Identifier Source: org_study_id