NCT01807091

Outpatient Induction Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

Feasibility of Outpatient Induction Chemotherapy for Adult Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies the feasibility of having induction chemotherapy in an outpatient setting. Patients with acute leukemia (AML) or advanced myelodysplastic syndrome (MDS), at least 18 years of age will be examined. Treating eligible patients with induction chemotherapy in an outpatient setting may save in healthcare cost and improve a patients' quality of life.

Detailed description

PRIMARY OBJECTIVES: Assess the feasibility of outpatient induction therapy for acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS) by examining whether: 1. \> 50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital. 2. \< 5% of patients die within 14 days of beginning outpatient chemotherapy. OUTLINE: Patients receive outpatient induction chemotherapy. STATISTICAL CONSIDERATIONS: The study was monitored to assure that there was not an excess probability of admission to the hospital during receipt of outpatient chemotherapy or death within 14 days of initiating chemotherapy as assessed by Bayesian posterior probabilities using the "predictive probabilities" tool (MD Anderson Cancer Center Department of Statistics). Stopping earlier would happen under 2 circumstances: 1. Excess probability that patients required admission to hospital during the 4-7 days of outpatient chemotherapy (predictive probability be \< 0.10, or 7 patients admitted and 3 not admitted among 10 patients enrolled versus the maximum acceptable rate of 4 patients admitted and 6 not admitted among 10 patients enrolled). 2. Excess probability that patients die during the 14 days after beginning outpatient treatment (predictive probability be \>0.90, for example in cases where there are 2 patient deaths within 14 days and less than 5 patients without deaths within 14 days, or in any case where there are 3 patient deaths within 14 days).

Conditions

• Adult Acute Myeloid Leukemia
• Adult Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Chemotherapy	Receive outpatient induction chemotherapy

Timeline

• Start date: 2013-05-21
• Primary completion: 2020-01-08
• Completion: 2020-01-08
• First posted: 2013-03-08
• Last updated: 2021-03-05
• Results posted: 2021-03-05

Locations

9 sites across 1 country: United States