Clinical trial NCT01807091: Outpatient Induction Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
Official title: Feasibility of Outpatient Induction Chemotherapy for Adult Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Acute Myeloid Leukemia
Adult Myelodysplastic Syndrome
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-03-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

1. \> 50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital.
2. \< 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:

1. 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).
2. 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).

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

Primary outcomes:
measure: Rate of Hospital Admission During Outpatient Induction Chemotherapy
timeFrame: During the 4-7 days of outpatient induction chemotherapy
measure: Death Within 14 Days of Initiating Outpatient Induction Chemotherapy
timeFrame: During the 14 days after beginning outpatient induction treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: Bozeman Deaconess Hospital
state: Montana
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and Oncology
state: Washington
city: Kirkland
country: United States
facility: EvergreenHealth Medical Center
state: Washington
city: Mount Vernon
country: United States
facility: Skagit Valley Hospital
state: Washington
city: Port Angeles
country: United States
facility: Olympic Medical Center
state: Washington
city: Redmond
country: United States
facility: Group Health Cooperative
state: Washington
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
city: Tacoma
country: United States
facility: Multicare Health System
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital and Clinics
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Pamela Becker
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Eli Estey
role: PRINCIPAL_INVESTIGATOR
References: