Spots Global Cancer Trial Database for Pilot Study of Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML)

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Trial Identification

Brief Title: Pilot Study of Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML)

Official Title: Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia

Study ID: NCT02101983

Conditions

Acute Myeloid Leukemia

Interventions

Cytosine Arabinoside

Study Description

Brief Summary: 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.

Detailed Description: 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.