Acute Myeloid Leukemia Clinical Trial

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

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.

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Full Description

PRIMARY OBJECTIVES:

Assess the feasibility of outpatient induction therapy for acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS) by examining whether:

> 50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital.
< 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:

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).
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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Signed written informed consent

The signed informed consent
The benefits/risks of the induction chemotherapy regimen will be reviewed, and a second consent may be necessary if the regimen will be administered according to a separate protocol
AML (acute promyelocytic leukemia [APL] excepted) or high-risk MDS (10-19% blasts in marrow by morphology or flow cytometry or blood)
Treatment-related mortality (TRM) score < 9.21 corresponding to a TRM rate of 3% when chemotherapy of similar intensity as proposed here is administered to inpatients
Blast count =< 10,000
Fibrinogen > 200
Afebrile with clear chest imaging and no signs of active viral, bacterial, fungal infection unless determined to be, at the discretion of the investigator, not clinically significant in the context of this study
Adequate cardiac function as demonstrated by left ventricular ejection fraction (LVEF) of 45% or greater, by multiple gated acquisition (MUGA) or echocardiogram; no ongoing cardiac issues such as uncontrolled arrhythmias or unstable angina or congestive heart failure
Patient must have an outpatient caregiver available
Patient must live within 30 minutes of the treating physician's office during outpatient treatment
Patient must be willing to return to the treating physician's office for outpatient follow-up once outpatient treatment is completed

Logistical requirements:

Space available in infusion room
Outpatient infusion pump available if continuous infusion required
Case discussed with infusion room nursing staff

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

17

Study ID:

NCT01807091

Recruitment Status:

Completed

Sponsor:

University of Washington

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There are 9 Locations for this study

See Locations Near You

Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
Kadlec Clinic Hematology and Oncology
Kennewick Washington, 99336, United States
EvergreenHealth Medical Center
Kirkland Washington, 98033, United States
Skagit Valley Hospital
Mount Vernon Washington, 98274, United States
Olympic Medical Center
Port Angeles Washington, 98362, United States
Group Health Cooperative
Redmond Washington, 98052, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle Washington, 98109, United States
Multicare Health System
Tacoma Washington, 98415, United States
Wenatchee Valley Hospital and Clinics
Wenatchee Washington, 98801, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

17

Study ID:

NCT01807091

Recruitment Status:

Completed

Sponsor:


University of Washington

How clear is this clinincal trial information?

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