Feasibility of Outpatient Induction Chemotherapy for Adult Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 17
- Locations
- 9
- Primary Endpoint
- Rate of Hospital Admission During Outpatient Induction Chemotherapy
Study Overview
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 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:
- > 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 Criteria
- Not provided
Arms & Interventions
Treatment (chemotherapy)
Participants received intensive initial or salvage induction chemotherapy regimens. These regimens would usually be administered in the inpatient setting, however participants received them outpatient. This study did not dictate the choice of induction chemotherapy regimen. The regimen was decided upon by patient and their treating oncologist and clinical care team. The induction chemotherapy regimens administrations spanned 4-7 days.
Intervention: Chemotherapy (Drug)
Outcomes
Primary Outcomes
Rate of Hospital Admission During Outpatient Induction Chemotherapy
Time Frame: During the 4-7 days of outpatient induction chemotherapy
Feasibility for this study objective would be considered a "success" if \>50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital.
Death Within 14 Days of Initiating Outpatient Induction Chemotherapy
Time Frame: During the 14 days after beginning outpatient induction treatment
Feasibility for this study objective would be considered a "success" if \<5% of patients die within 14 days of beginning outpatient chemotherapy.
Secondary Outcomes
No secondary outcomes reported
Investigators
Elihu H. Estey
Professor
University of Washington