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:

Completed

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
  • SECONDARY ID: RG1000945
  • 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:

      Assess the feasibility of outpatient induction therapy for acute myeloid leukemia (AML) or
      advanced myelodysplastic syndrome (MDS) by examining whether:

        1. > 50% of patients treated as outpatients can complete chemotherapy without being
           admitted to hospital.

        2. < 5% of patients die within 14 days of beginning outpatient chemotherapy.

      OUTLINE:

      Patients receive outpatient induction chemotherapy.

      STATISTICAL CONSIDERATIONS:

      The study was monitored to assure that there was not an excess probability of admission to
      the hospital during receipt of outpatient chemotherapy or death within 14 days of initiating
      chemotherapy as assessed by Bayesian posterior probabilities using the "predictive
      probabilities" tool (MD Anderson Cancer Center Department of Statistics).

      Stopping earlier would happen under 2 circumstances:

        1. Excess probability that patients required admission to hospital during the 4-7 days of
           outpatient chemotherapy (predictive probability be < 0.10, or 7 patients admitted and 3
           not admitted among 10 patients enrolled versus the maximum acceptable rate of 4 patients
           admitted and 6 not admitted among 10 patients enrolled).

        2. Excess probability that patients die during the 14 days after beginning outpatient
           treatment (predictive probability be >0.90, for example in cases where there are 2
           patient deaths within 14 days and less than 5 patients without deaths within 14 days, or
           in any case where there are 3 patient deaths within 14 days).
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (chemotherapy)ExperimentalParticipants received intensive initial or salvage induction chemotherapy regimens. These regimens would usually be administered in the inpatient setting, however participants received them outpatient. This study did not dictate the choice of induction chemotherapy regimen. The regimen was decided upon by patient and their treating oncologist and clinical care team. The induction chemotherapy regimens administrations spanned 4-7 days.
  • 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 During Outpatient Induction Chemotherapy
Time Frame:During the 4-7 days of outpatient induction chemotherapy
Safety Issue:
Description:Feasibility for this study objective would be considered a "success" if >50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital.

Details

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

Last Updated

March 5, 2021