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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01807091
First received: March 6, 2013
Last updated: March 19, 2014
Last verified: March 2014

March 6, 2013
March 19, 2014
May 2013
March 2015   (final data collection date for primary outcome measure)
  • Rate of hospital admission [ Time Frame: During the 4-7 days of outpatient chemotherapy ] [ Designated as safety issue: No ]
  • Patient death [ Time Frame: During the 14 days after beginning outpatient treatment ] [ Designated as safety issue: No ]
  • Rate of hospital admission [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Death within 10 days [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01807091 on ClinicalTrials.gov Archive Site
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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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Receive outpatient induction chemotherapy
Other Name: chemo
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
March 2015   (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
  • 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 Seattle Cancer Care Alliance during outpatient treatment
  • Patient must be willing to return to the Seattle Cancer Care Alliance 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
Both
18 Years and older
No
United States
 
NCT01807091
7910, NCI-2013-00483, 7910, P30CA015704
No
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Pamela Becker Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
University of Washington
March 2014

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