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

This study is currently recruiting participants.
Verified July 2017 by University of Washington
Sponsor:
ClinicalTrials.gov Identifier:
NCT01807091
First Posted: March 8, 2013
Last Update Posted: July 5, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington
March 6, 2013
March 8, 2013
July 5, 2017
May 21, 2013
April 1, 2018   (Final data collection date for primary outcome measure)
  • Rate of hospital admission [ Time Frame: During the 4-7 days of outpatient chemotherapy ]
  • TRM rate [ Time Frame: During the 14 days after beginning outpatient treatment ]
  • Rate of hospital admission [ Time Frame: Up to 2 years ]
  • Death within 10 days [ Time Frame: 10 days ]
Complete list of historical versions of study NCT01807091 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Outpatient Induction Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
Feasibility of Outpatient Induction Chemotherapy for Adult Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Adult Acute Myeloid Leukemia
  • Adult Myelodysplastic Syndrome
Drug: Chemotherapy
Receive outpatient induction chemotherapy
Other Names:
  • Chemo
  • Chemotherapy (NOS)
  • Chemotherapy, Cancer, General
Experimental: Treatment (chemotherapy)
Patients receive outpatient induction chemotherapy.
Intervention: Drug: Chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
Not Provided
April 1, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
United States
 
 
NCT01807091
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 )
No
Not Provided
Not Provided
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Pamela Becker Fred Hutch/University of Washington Cancer Consortium
University of Washington
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP