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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University of Washington
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
First received: March 6, 2013
Last updated: November 26, 2014
Last verified: November 2014

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 Intervention
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
de Novo Myelodysplastic Syndromes
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Drug: chemotherapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Outpatient Induction Chemotherapy for Adult Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Rate of hospital admission [ Time Frame: During the 4-7 days of outpatient chemotherapy ] [ Designated as safety issue: No ]
  • TRM rate [ Time Frame: During the 14 days after beginning outpatient treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: May 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (chemotherapy)
Patients receive outpatient induction chemotherapy.
Drug: chemotherapy
Receive outpatient induction chemotherapy
Other Name: chemo

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • White blood cell (WBC) count =< 10,000
  • Fibrinogen > 200
  • Afebrile with a clear chest x-ray and no signs of active viral, bacterial, or fungal infection
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807091

United States, Montana
Bozeman Deaconess Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Jack O. Hensold    406-585-5070      
Principal Investigator: Jack O. Hensold         
United States, Washington
Columbia Basin Hematology and Oncology PLLC Recruiting
Kennewick, Washington, United States, 99336
Contact: Thomas A. Rado    509-783-0144    research@cbho.org   
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 Hutchinson Cancer Research Center/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 Medical Center Recruiting
Wenatchee, Washington, United States, 98801
Contact: Mitchell A. Garrison    509-663-8711      
Principal Investigator: Mitchell A. Garrison         
Sponsors and Collaborators
University of Washington
Principal Investigator: Pamela Becker Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01807091     History of Changes
Other Study ID Numbers: 7910, NCI-2013-00483, 7910, P30CA015704
Study First Received: March 6, 2013
Last Updated: November 26, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia, Erythroblastic, Acute
Leukemia, Megakaryoblastic, Acute
Leukemia, Monocytic, Acute
Leukemia, Myeloid
Leukemia, Myelomonocytic, Acute
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms by Histologic Type
Pathologic Processes
Precancerous Conditions

ClinicalTrials.gov processed this record on March 31, 2015