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

NCT ID: NCT01807091

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-21
• Study Completion Date: 2020-01-08

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).

Conditions

Adult Acute Myeloid Leukemia; Adult Myelodysplastic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Chemotherapy

Intervention Type: DRUG

Receive outpatient induction chemotherapy

Interventions

Chemotherapy

Receive outpatient induction chemotherapy

Intervention Type: DRUG

Other Intervention Names

Chemo; Chemotherapy (NOS); Chemotherapy, Cancer, General

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Elihu H. Estey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela Becker

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Eli Estey

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2013-00483

Identifier Type: REGISTRY

Identifier Source: secondary_id

7910

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RG1000945

Identifier Type: OTHER

Identifier Source: secondary_id

7910

Identifier Type: -

Identifier Source: org_study_id