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

Adult Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807091
• Other study ID #: 7910
• Secondary ID: NCI-2013-0048379
• Status: Completed
• Phase: N/A
• Start date: May 21, 2013
• Est. completion date: January 8, 2020

Study information

• Verified date: February 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 8, 2020
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Acute Myeloid Leukemia
• Adult Myelodysplastic Syndrome
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Chemotherapy
Receive outpatient induction chemotherapy

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Hospital Admission During 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.	During the 4-7 days of outpatient induction chemotherapy
Primary	Death Within 14 Days of Initiating Outpatient Induction Chemotherapy	Feasibility for this study objective would be considered a "success" if <5% of patients die within 14 days of beginning outpatient chemotherapy.	During the 14 days after beginning outpatient induction treatment