Pilot Study of Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML)

Study Overview
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Brief Summary
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High-dose cytarabine (HiDAC) is considered a standard chemotherapy treatment for patients with acute myeloid leukemia. However, most patients receiving this therapy are required to be admitted to the hospital during their treatment course. The purpose of this study is to compare the safety and cost of high-dose cytarabine treatment given in an in-patient setting versus an out-patient setting.

Detailed Description
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The primary objective of this study is to: • To determine the incidence of grade 3 to 5 non-hematologic toxicity of high-dose cytarabine (HiDAC) for AML consolidation administered in an outpatient setting. The secondary objectives of this study are to: To determine cost effectiveness of outpatient HiDAC consolidation versus the standard of care inpatient HiDAC consolidation. Evaluate patient quality of life (QOL) with this outpatient regimen in comparison to that with the standard inpatient regimen.

Official Title
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Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Cytosine Arabinoside


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria for Outpatient Administration of HiDAC Unequivocal diagnosis of AML (>20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia). Documented complete remission (CR) following induction chemotherapy as defined as (18): Bone marrow with <5% blasts; absence of blasts with Auer rods Absolute neutrophil count >1000/mcL Platelets >100,000/mcL Independence of red cell transfusions Absence of extramedullary disease Age ≥ 55 years. Relapsed AML patients are eligible as long as they meet other inclusion and exclusion criteria. Good performance status of (ECOG 0-2), see appendix 15.3. Adequate renal and hepatic function (Cr ≤ 1.2, alkaline phosphatase <3.0 x upper limit of normal, total bilirubin <1.5 x upper limit of normal unless there is a history of Gilbert's disease). Inclusion Criteria for Quality of Life Comparison Group All patients decline to participate as an out-patient or who are not eligible for participation in the out-patient portion of the study will be approached to participate in the QOL comparison. Age ≥ 18 years Exclusion Criteria: Exclusion Criteria for All Patients Active, uncontrolled viral, bacterial, or fungal infection. Documented CNS leukemia. If unable to do a reliable cerebellar examination for monitoring of neurotoxicity. History of prior autologous or allogeneic bone marrow/stem cell transplant. New York Heart Association class III/IV congestive heart failure, see appendix 15.4, or active ischemic heart disease. Pregnant or lactating women (women and men of childbearing age should use effective contraception). Concomitant active malignancy requiring treatment with cytotoxic chemotherapy or radiation therapy. (Ongoing hormonal therapy for the treatment of malignancy would not exclude patients from this trial.) Time period of greater than 10 weeks between initiation of induction chemotherapy and day 1 of the first cycle of consolidation chemotherapy. Patients seropositive for infection with Human Immunodeficiency Virus (HIV) are excluded due to potential for serious infectious complications associated with T-cell suppressive therapy in these patients.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 65 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient HiDAC Consolidation<br>Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle. | Drug: Cytosine Arabinoside<br> <br> * Other names: 1-B-Arabinoe-furanosyl-cytosine;|
| Active Comparator: Quality of Life Comparison Group<br>Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy. | Drug: Cytosine Arabinoside<br> <br> * Other names: 1-B-Arabinoe-furanosyl-cytosine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Grades 3 to 5 Non-hematologic Toxicity. | To determine the incidence of number of grades 3 to 5 non-hematologic toxicity of high-dose cytarabine for AML consolidation administered in an outpatient setting. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Successfully Completed the of Quality of Life Form | Subjects receiving outpatient high dose cytarabine or inpatient high dose cytarabine will complete the European Organization for Research and Treatment of Cancer Quality of Life tool on the last day of each cycle of chemotherapy. It encompasses 5 functional scales, 3 symptom scales and a global health measure. Scores range from 0-100 with higher scores associated with improved quality of life. | 3 months | 
| Mean Cost Savings |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute myeloid leukemia, outpatient consolidation treatment