Clinical Trials /

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

NCT01807091

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.

Related Conditions:
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Outpatient Induction Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
  • Official Title: Feasibility of Outpatient Induction Chemotherapy for Adult Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

Clinical Trial IDs

  • ORG STUDY ID: 7910
  • SECONDARY ID: NCI-2013-00483
  • SECONDARY ID: 7910
  • SECONDARY ID: P30CA015704
  • NCT ID: NCT01807091

Conditions

  • Adult Acute Myeloid Leukemia
  • Adult Myelodysplastic Syndrome

Interventions

DrugSynonymsArms
ChemotherapyChemo, Chemotherapy (NOS), Chemotherapy, Cancer, GeneralTreatment (chemotherapy)

Purpose

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.

Detailed Description

      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 Arms

NameTypeDescriptionInterventions
Treatment (chemotherapy)ExperimentalPatients receive outpatient induction chemotherapy.
  • Chemotherapy

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Rate of hospital admission
Time Frame:During the 4-7 days of outpatient chemotherapy
Safety Issue:
Description:

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Washington

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