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

Status: Active

Description

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.

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

Locations & Contacts

Montana

Bozeman
Bozeman Deaconess Hospital
Status: Active
Contact: Jack Oliver Hensold
Phone: 406-585-5070
Email: jhensold@bdh-boz.com

Washington

Kennewick
Kadlec Clinic Hematology and Oncology
Status: Active
Contact: Thomas A. Rado
Phone: 509-783-0144
Email: research@cbho.org
Kirkland
EvergreenHealth Medical Center
Status: Active
Contact: Aimee Debra Kohn
Phone: 425-899-3953
Email: adkohn@uw.edu
Mount Vernon
Skagit Valley Hospital
Status: Active
Contact: Kiarash Kojouri
Phone: 360-428-2146
Email: kkojouri@skagitvalleyhospital.org
Port Angeles
Olympic Medical Center
Status: Active
Contact: Thomas D. Kummet
Phone: 360-683-9895
Email: tkummet@olympicmedical.org
Redmond
Group Health Cooperative
Status: Active
Contact: Eric Y. Chen
Phone: 425-502-3690
Email: chen.e@ghc.org
Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Contact: Pamela Sue Becker
Phone: 206-616-1589
Email: pbecker@u.washington.edu
Tacoma
MultiCare Tacoma General Hospital
Status: Active
Contact: John A. Keech
Phone: 253-403-1677
Email: john.keech@multicare.org
Wenatchee
Wenatchee Valley Hospital and Clinics
Status: Active
Contact: Mitchell A. Garrison
Phone: 509-663-8711
Email: mgarrison@wvmedical.com

Trial Objectives and Outline

PRIMARY OBJECTIVES:

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.

OUTLINE:

Patients receive outpatient induction chemotherapy.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Treatment

Lead Organization

Lead Organization
Fred Hutch / University of Washington Cancer Consortium

Principal Investigator
Pamela Sue Becker

Trial IDs

Primary ID 7910
Secondary IDs NCI-2013-00483
Clinicaltrials.gov ID NCT01807091