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



Status:Recruiting
Conditions:Blood Cancer, Women's Studies, Hematology
Therapuetic Areas:Hematology, Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:11/11/2018
Start Date:May 21, 2013

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

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.

PRIMARY OBJECTIVES:

I. 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 or < 5% of patients
die within 14 days of beginning outpatient chemotherapy.

OUTLINE:

Patients receive outpatient induction chemotherapy.

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
We found this trial at
9
sites
915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Principal Investigator: Jack O. Hensold
Phone: 406-585-5070
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Kennewick, Washington 99336
Principal Investigator: Thomas A. Rado
Phone: 509-783-0144
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Kennewick, WA
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Kirkland, Washington 98033
Principal Investigator: Aimee D. Kohn
Phone: 425-899-3953
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Kirkland, WA
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Mount Vernon, Washington 98274
Principal Investigator: Kiarash Kojouri
Phone: 360-428-2146
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Mount Vernon, WA
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Port Angeles, Washington 98362
Principal Investigator: Thomas D. Kummet
Phone: 360-683-9895
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Port Angeles, WA
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Redmond, Washington 98052
Principal Investigator: Eric Y. Chen
Phone: 425-502-3690
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Redmond, WA
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Seattle, Washington 98109
Principal Investigator: Pamela S. Becker
Phone: 206-616-1589
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Seattle, WA
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314 Martin Luther King Junior Way
Tacoma, Washington 98405
(253) 403-5200
Principal Investigator: John A. Keech
Phone: 253-403-1677
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
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Wenatchee, Washington 98801
Principal Investigator: Mitchell A. Garrison
Phone: 509-663-8711
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Wenatchee, WA
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