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

Primary Purpose

Adult Acute Myeloid Leukemia, Adult Myelodysplastic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chemotherapy
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bozeman Deaconess Hospital
  • Kadlec Clinic Hematology and Oncology
  • EvergreenHealth Medical Center
  • Skagit Valley Hospital
  • Olympic Medical Center
  • Group Health Cooperative
  • Fred Hutch/University of Washington Cancer Consortium
  • Multicare Health System
  • Wenatchee Valley Hospital and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (chemotherapy)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2013
Last Updated
February 11, 2021
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01807091
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 21, 2013 (Actual)
Primary Completion Date
January 8, 2020 (Actual)
Study Completion Date
January 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. 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: 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). 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Acute Myeloid Leukemia, Adult Myelodysplastic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (chemotherapy)
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General
Intervention Description
Receive outpatient induction chemotherapy
Primary Outcome Measure Information:
Title
Rate of Hospital Admission During Outpatient Induction Chemotherapy
Description
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.
Time Frame
During the 4-7 days of outpatient induction chemotherapy
Title
Death Within 14 Days of Initiating Outpatient Induction Chemotherapy
Description
Feasibility for this study objective would be considered a "success" if <5% of patients die within 14 days of beginning outpatient chemotherapy.
Time Frame
During the 14 days after beginning outpatient induction treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Becker
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eli Estey
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
EvergreenHealth Medical Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Skagit Valley Hospital
City
Mount Vernon
State/Province
Washington
ZIP/Postal Code
98274
Country
United States
Facility Name
Olympic Medical Center
City
Port Angeles
State/Province
Washington
ZIP/Postal Code
98362
Country
United States
Facility Name
Group Health Cooperative
City
Redmond
State/Province
Washington
ZIP/Postal Code
98052
Country
United States
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Multicare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98415
Country
United States
Facility Name
Wenatchee Valley Hospital and Clinics
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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