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

Not Applicable

Completed

• Conditions: Adult Acute Myeloid Leukemia; Adult Myelodysplastic Syndrome
• Interventions: Drug: Chemotherapy

• Registration Number: NCT01807091
• Lead Sponsor: University of Washington

Brief Summary

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).

Study Timeline

• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-08
• Study Start: 2013-05-21
• Primary Completion: 2020-01-08
• Study Completion: 2020-01-08
• Results First Submitted: 2020-12-24
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-11
• Last Update Submitted: 2021-02-11
• Results First Posted: 2021-03-05
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (chemotherapy)	Chemotherapy	Participants 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.

Primary Outcome Measures

Name	Time	Method
Rate of Hospital Admission During Outpatient Induction Chemotherapy	During the 4-7 days of outpatient induction chemotherapy	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.
Death Within 14 Days of Initiating Outpatient Induction Chemotherapy	During the 14 days after beginning outpatient induction treatment	Feasibility for this study objective would be considered a "success" if \<5% of patients die within 14 days of beginning outpatient chemotherapy.

Trial Locations

Locations (9)

Bozeman Deaconess Hospital; 🇺🇸 Bozeman, Montana, United States

Kadlec Clinic Hematology and Oncology; 🇺🇸 Kennewick, Washington, United States

EvergreenHealth Medical Center; 🇺🇸 Kirkland, Washington, United States

Olympic Medical Center; 🇺🇸 Port Angeles, Washington, United States

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States

Group Health Cooperative; 🇺🇸 Redmond, Washington, United States

Wenatchee Valley Hospital and Clinics; 🇺🇸 Wenatchee, Washington, United States

Skagit Valley Hospital; 🇺🇸 Mount Vernon, Washington, United States

Multicare Health System; 🇺🇸 Tacoma, Washington, United States