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

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ClinicalTrials.gov Identifier: NCT01807091
Recruitment Status : Completed
First Posted : March 8, 2013
Results First Posted : March 5, 2021
Last Update Posted : March 5, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Elihu H. Estey, University of Washington

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adult Acute Myeloid Leukemia Adult Myelodysplastic Syndrome Drug: Chemotherapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Outpatient Induction Chemotherapy for Adult Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
Actual Study Start Date : May 21, 2013
Actual Primary Completion Date : January 8, 2020
Actual Study Completion Date : January 8, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Hospital Admission During Outpatient Induction Chemotherapy [ Time Frame: During the 4-7 days of 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.

  2. Death Within 14 Days of Initiating Outpatient Induction Chemotherapy [ Time Frame: During the 14 days after beginning outpatient induction treatment ]
    Feasibility for this study objective would be considered a "success" if <5% of patients die within 14 days of beginning outpatient chemotherapy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807091


Locations
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United States, Montana
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
United States, Washington
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States, 99336
EvergreenHealth Medical Center
Kirkland, Washington, United States, 98033
Skagit Valley Hospital
Mount Vernon, Washington, United States, 98274
Olympic Medical Center
Port Angeles, Washington, United States, 98362
Group Health Cooperative
Redmond, Washington, United States, 98052
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Multicare Health System
Tacoma, Washington, United States, 98415
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States, 98801
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Pamela Becker Fred Hutch/University of Washington Cancer Consortium
Principal Investigator: Eli Estey Fred Hutch/University of Washington Cancer Consortium
  Study Documents (Full-Text)

Documents provided by Elihu H. Estey, University of Washington:
Study Protocol and Statistical Analysis Plan  [PDF] February 20, 2019

More Information
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Responsible Party: Elihu H. Estey, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01807091    
Other Study ID Numbers: 7910
NCI-2013-00483 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
7910 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
RG1000945 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: March 8, 2013    Key Record Dates
Results First Posted: March 5, 2021
Last Update Posted: March 5, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
 Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions