High-dose cytarabine (HiDAC) is considered a standard chemotherapy treatment for patients with acute myeloid leukemia. However, most patients receiving this therapy are required to be admitted to the hospital during their treatment course. The purpose of this study is to compare the safety and cost of high-dose cytarabine treatment given in an in-patient setting versus an out-patient setting.
The primary objective of this study is to: • To determine the incidence of grade 3 to 5 non-hematologic toxicity of high-dose cytarabine (HiDAC) for AML consolidation administered in an outpatient setting. The secondary objectives of this study are to: * To determine cost effectiveness of outpatient HiDAC consolidation versus the standard of care inpatient HiDAC consolidation. * Evaluate patient quality of life (QOL) with this outpatient regimen in comparison to that with the standard inpatient regimen.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
University of Rochester
Rochester, New York, United States
Number of Participants With Grades 3 to 5 Non-hematologic Toxicity.
To determine the incidence of number of grades 3 to 5 non-hematologic toxicity of high-dose cytarabine for AML consolidation administered in an outpatient setting.
Time frame: 3 months
Number of Participants Who Successfully Completed the of Quality of Life Form
Subjects receiving outpatient high dose cytarabine or inpatient high dose cytarabine will complete the European Organization for Research and Treatment of Cancer Quality of Life tool on the last day of each cycle of chemotherapy. It encompasses 5 functional scales, 3 symptom scales and a global health measure. Scores range from 0-100 with higher scores associated with improved quality of life.
Time frame: 3 months
Mean Cost Savings
Time frame: 3 months
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