Status:
COMPLETED
Outpatient Induction Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adult Acute Myeloid Leukemia
Adult Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
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 tre...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 21 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01807091
Start Date
May 21 2013
End Date
January 8 2020
Last Update
March 5 2021
Active Locations (9)
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1
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
2
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States, 99336
3
EvergreenHealth Medical Center
Kirkland, Washington, United States, 98033
4
Skagit Valley Hospital
Mount Vernon, Washington, United States, 98274