Phase 2 Study of Early Discharge and Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML
PRIMARY OBJECTIVES:
I. Estimate the early death rate in patients discharged after completion of intensive
induction or salvage chemotherapy.
SECONDARY OBJECTIVES:
I. Compare the costs incurred by patients discharged early after induction or salvage
chemotherapy with similar patients who are discharged only after their blood counts recover.
II. Compare resource utilization (transfusions, etc.) in patients discharged early after
induction or salvage chemotherapy with similar patients who are discharged only after blood
count recovery.
III. Compare the quality of life in patients discharged early after induction or salvage
chemotherapy with similar patients who are discharged only after their blood counts recover.
OUTLINE:
Patients are discharged within 72 hours after completion of chemotherapy and undergo
standard outpatient care by a registered nurse (RN), physician assistant (PA), or
resident/fellow at a local facility or the study center approximately 3 times per week, as
clinically indicated for up to 45 days.
After completion of study, patients are followed up for 1 month.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Proportion of early deaths among patients who are discharged after completion of induction or salvage chemotherapy
A one-sided lower exact 95% confidence interval for the proportion of early deaths after discharge will be calculated.
Up to day 35
No
Roland Walter
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
2449.00
NCT01235572
December 2010
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |