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

Completed · Not applicable

Conditions studied: Adult Acute Myeloid Leukemia, Adult Myelodysplastic Syndrome

In brief

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.

Key facts

Study ID

NCT01807091

Run by

University of Washington

People needed

17

Starts

2013-05-21

Expected to finish

2020-01-08

Last updated by the study team

2021-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Bozeman Deaconess Hospital — Bozeman, Montana, United States
• Kadlec Clinic Hematology and Oncology — Kennewick, Washington, United States
• EvergreenHealth Medical Center — Kirkland, Washington, United States
• Skagit Valley Hospital — Mount Vernon, Washington, United States
• Olympic Medical Center — Port Angeles, Washington, United States
• Group Health Cooperative — Redmond, Washington, United States
• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States
• Multicare Health System — Tacoma, Washington, United States
• Wenatchee Valley Hospital and Clinics — Wenatchee, Washington, United States

Full record on ClinicalTrials.gov

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