NCT02101983

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 55 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Cytosine Arabinoside

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-12-01
• Completion: 2017-08-01
• First posted: 2014-04-02
• Last updated: 2018-06-27
• Results posted: 2018-06-27

Locations

1 site across 1 country: United States