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

Study Overview
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Brief Summary
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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
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PRIMARY OBJECTIVES: 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. < 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: 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). 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).

Official Title
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Feasibility of Outpatient Induction Chemotherapy for Adult Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

Conditions
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Adult Acute Myeloid Leukemia, Adult Myelodysplastic Syndrome

Intervention / Treatment
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* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (chemotherapy)<br>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. | Drug: Chemotherapy<br>* Receive outpatient induction chemotherapy<br>* Other names: Chemotherapy, Cancer, General;|

What is the study measuring?
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Primary Outcome Measures

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