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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01807091
Recruitment Status : Recruiting
First Posted : March 8, 2013
Last Update Posted : November 9, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

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:


I. 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 or < 5% of patients die within 14 days of beginning outpatient chemotherapy.


Patients receive outpatient induction chemotherapy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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
Estimated Primary Completion Date : October 1, 2019

Arm Intervention/treatment
Experimental: Treatment (chemotherapy)
Patients receive outpatient induction chemotherapy.
Drug: Chemotherapy
Receive outpatient induction chemotherapy
Other Names:
  • Chemo
  • Chemotherapy (NOS)
  • Chemotherapy, Cancer, General

Primary Outcome Measures :
  1. Rate of hospital admission [ Time Frame: During the 4-7 days of outpatient chemotherapy ]
  2. TRM rate [ Time Frame: During the 14 days after beginning outpatient treatment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01807091

United States, Montana
Bozeman Deaconess Hospital Recruiting
Bozeman, Montana, United States, 59715
Contact: Jack O. Hensold    406-585-5070   
Principal Investigator: Jack O. Hensold         
United States, Washington
Kadlec Clinic Hematology and Oncology Recruiting
Kennewick, Washington, United States, 99336
Contact: Thomas A. Rado    509-783-0144   
Principal Investigator: Thomas A. Rado         
EvergreenHealth Medical Center Recruiting
Kirkland, Washington, United States, 98033
Contact: Aimee D. Kohn    425-899-3953   
Principal Investigator: Aimee D. Kohn         
Skagit Valley Hospital Recruiting
Mount Vernon, Washington, United States, 98274
Contact: Kiarash Kojouri    360-428-2146   
Principal Investigator: Kiarash Kojouri         
Olympic Medical Center Recruiting
Port Angeles, Washington, United States, 98362
Contact: Thomas D. Kummet    360-683-9895   
Principal Investigator: Thomas D. Kummet         
Group Health Cooperative Recruiting
Redmond, Washington, United States, 98052
Contact: Eric Y. Chen    425-502-3690   
Principal Investigator: Eric Y. Chen         
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Pamela S. Becker    206-616-1589   
Principal Investigator: Pamela S. Becker         
Multicare Health System Recruiting
Tacoma, Washington, United States, 98415
Contact: John A. Keech    253-403-1677   
Principal Investigator: John A. Keech         
Wenatchee Valley Hospital and Clinics Recruiting
Wenatchee, Washington, United States, 98801
Contact: Mitchell A. Garrison    509-663-8711   
Principal Investigator: Mitchell A. Garrison         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Pamela Becker Fred Hutch/University of Washington Cancer Consortium

Responsible Party: University of Washington Identifier: NCT01807091     History of Changes
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 )
First Posted: March 8, 2013    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions