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

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

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.

Study Overview

• Status: Completed
• Conditions: Adult Acute Myeloid Leukemia; Adult Myelodysplastic Syndrome
• Intervention / Treatment: Drug: Chemotherapy

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).

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Montana
    • Bozeman, Montana, United States, 59715
      • Bozeman Deaconess Hospital
  • Washington
    • Kennewick, Washington, United States, 99336
      • Kadlec Clinic Hematology and Oncology
    • Kirkland, Washington, United States, 98033
      • EvergreenHealth Medical Center
    • Mount Vernon, Washington, United States, 98274
      • Skagit Valley Hospital
    • Port Angeles, Washington, United States, 98362
      • Olympic Medical Center
    • Redmond, Washington, United States, 98052
      • Group Health Cooperative
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium
    • Tacoma, Washington, United States, 98415
      • MultiCare Health System
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: Chemotherapy; Receive outpatient induction chemotherapy; Other Names: Chemo; Chemotherapy (NOS); Chemotherapy, Cancer, General

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Eli Estey, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2013
• Primary Completion (Actual): January 8, 2020
• Study Completion (Actual): January 8, 2020

Study Registration Dates

• First Submitted: March 6, 2013
• First Submitted That Met QC Criteria: March 7, 2013
• First Posted (Estimate): March 8, 2013

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia
• Other Study ID Numbers: 7910 (Fred Hutch/University of Washington Cancer Consortium); P30CA015704 (U.S. NIH Grant/Contract); NCI-2013-00483 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); RG1000945 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No